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Background: Studies suggest that individualized music listening is an effective, non-pharmacological intervention for improving the quality of life of people with dementia in the institutional care setting. Noting that most people with dementia live at home, we conduct a randomized controlled trial to assess the feasibility and effectiveness of an app-based individualized music listening intervention for people with dementia in the home care setting. The intervention is delivered by family caregivers. Methods: We will recruit N = 130 dyads consisting of one person with dementia living at home and their family caregiver. After a baseline assessment, dyads are randomly assigned by gender to either the intervention or control group. People with dementia in the intervention group listen to individualized music playlists for 20 min every other day for six weeks via the self-developed Individualized Music and Dementia app. The control group receives standard care. All dyads complete paper-and-pencil questionnaires six weeks before the start of the intervention (T0), directly before the intervention (T1), directly after the intervention (T2), and six weeks later (T3). During the intervention period, all caregivers also complete daily ecological momentary assessments via the app. During three home visits, a trained project member will observe the dyads and collect hair samples. After the intervention, semi-structured interviews will be conducted to collect information about participants' experiences with the app and intervention. The primary outcome is the attainment of individual goals established during the baseline assessment. Secondary outcomes are the well-being, physiological stress and quality of life of people with dementia and their caregivers; people with dementia's behavioural and psychological symptoms of dementia, resistance during care, and reactions to the music; caregivers' burden of care, positive aspects of care, and caregiving self-efficacy; and the quality of the caregiver-care recipient interaction. Discussion: Our study will assess the extent to which an app-based individualized music listening intervention is feasible and effective for enhancing the well-being and quality of life of people with dementia living at home and their family caregivers. Trial registration: German Clinical Trials Register DRKS00025502 and ISRCTN registry ISRCTN68084105, https://doi.org/10.1186/ISRCTN68084105 [ABSTRACT FROM AUTHOR]

Background: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. This protocol paper describes a two-arm, multi-center, randomized controlled trial on the short- and longer-term effectiveness and cost-effectiveness of a brief, individually tailored behavioral parent training program for children with behavioral difficulties. Methods: Parents of children aged 2–12 years referred to a child mental healthcare center are randomized to (i) three sessions of behavioral parent training with optional booster sessions or (ii) care as usual. To evaluate effectiveness, our primary outcome is the mean severity of five daily ratings by parents of four selected behavioral difficulties. Secondary outcomes include measures of parent and child behavior, well-being, and parent–child interaction. We explore whether child and parent characteristics moderate intervention effects. To evaluate cost-effectiveness, the use and costs of mental healthcare and utilities are measured. Finally, parents' and therapists' satisfaction with the brief program are explored. Measurements take place at baseline (T0), one week after the brief parent training, or eight weeks after baseline (in case of care as usual) (T1), and six months (T2) and twelve months (T3) after T1. Discussion: The results of this trial could have meaningful societal implications for children with behavioral difficulties and their parents. If we find the brief behavioral parent training to be more (cost-)effective than care as usual, it could be used in clinical practice to make parent training more accessible. Trial registration: The trial is prospectively registered at ClinicalTrials.gov (NCT05591820) on October 24th, 2022 and updated throughout the trial. [ABSTRACT FROM AUTHOR]

Background: Low-intensity cognitive behavioural therapy (LICBT) has been recommended as a primary intervention in the tiered care for mild to moderate generalised anxiety disorder. However, LICBT for generalised anxiety disorder are markedly diverse and efficacy data on various outcomes have not been systematically reviewed. This meta-analysis aimed to synthesise effect sizes of three NICE-recommended LICBT for generalised anxiety disorder: non-facilitated self-help, guided self-help, and psychoeducational groups. Methods: A systematic literature review of randomised controlled trials (RCTs) examining LICBT for generalised anxiety disorder in the last 23 years (2000–2023) was conducted. Efficacy data for anxiety, depression, and worry outcomes were separately meta-analysed. The study was reported following the PRISMA guidelines. Results: The systematic review identified 12 RCTs out of 1205 papers. The three meta-analyses consisted of 12 (anxiety), 11 (depression), and 9 (worry) effect sizes respectively, including total sample sizes of 1201 (anxiety), 1164 (depression), and 908 (worry). The adjusted effect sizes for reductions in anxiety (g = -0.63), depression (g = -0.48), and worry (g = -0.64) were all in the medium range, favouring LICBT over control conditions. Between-study heterogeneity was significant on anxiety and worry, with no specific moderators identified by meta-regression. Conclusions: LICBT has shown promise as an effective and efficient treatment modality for individuals with generalised anxiety disorder. Future research comparing various LICBT subtypes and treatment components will further inform clinical practice. Trial registration: This systematic review protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO; record ID CRD42021285590). [ABSTRACT FROM AUTHOR]

Background: There is ongoing debate regarding the treatment of severe and multiple traumatized children and adolescents with post-traumatic stress disorder (PTSD). Many clinicians favor a phase-based treatment approach (i.e., a stabilization phase prior to trauma-focused therapy) over immediate trauma-focused psychological treatment, despite the lack of scientific evidence. Research on the effects of different treatment approaches is needed for children and adolescents with (symptoms of complex) PTSD resulting from repeated sexual and/or physical abuse during childhood. Objective: This paper describes the rationale, study design, and methods of the MARS-study, a two-arm randomized controlled trial (RCT) that aims to compare the results of phase-based treatment with those of immediate trauma-focused treatment and determine whether immediate trauma-focused treatment is not worse than phase-based treatment in reducing PTSD symptoms. Methods: Participants are individuals between 12 and 18 years who meet the diagnostic criteria for PTSD due to repeated sexual abuse, physical abuse, or domestic violence during childhood. Participants will be blindly allocated to either the phase-based or immediate trauma-focused treatment condition. In the phase-based treatment condition, participants receive 12 sessions of the Dutch version of Skill Training in Affective and Interpersonal Regulation (STAIR-A), followed by 12 sessions of EMDR therapy. In the immediate trauma-focused condition, the participants receive 12 sessions of EMDR therapy. The two groups are compared for several outcome variables before treatment, mid-treatment (only in the phase-based treatment condition), after 12 trauma-focused treatment sessions (post-treatment), and six months post-treatment (follow-up). The main parameter is the presence and severity of PTSD symptoms (Clinician-Administered PTSD Scale for Children and Adolescents, CAPS-CA). The secondary outcome variables are the severity of complex PTSD symptoms (Interpersonal Problems as measured by the Experiences in Close Relationship-Revised, ECR-RC; Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale, DERS; Self Esteem as measured by the Rosenberg Self Esteem Scale, RSES), changes in anxiety and mood symptoms (Revised Anxiety and Depression Scale; RCADS), changes in posttraumatic cognitions (Child Posttraumatic Cognitions Inventory, CPTCI), changes in general psychopathology symptoms (Child Behavior Checklist, CBCL), and Quality of Life (Youth Outcome Questionnaire, Y-OQ-30). Furthermore, parental stress (Opvoedingsvragenlijst, OBVL) and patient-therapist relationship (Feedback Informed Treatment, FIT) will be measured, whereas PTSD symptoms will be monitored in each session during both treatment conditions (Children's Revised Impact of Event Scale, CRIES-13). Discussion: Treating (symptoms of complex) PTSD in children and adolescents with a history of repeated sexual and/or physical abuse during childhood is of great importance. However, there is a lack of consensus among trauma experts regarding the optimal treatment approach. The results of the current study may have important implications for selecting effective treatment options for clinicians working with children and adolescents who experience the effects of exposure to multiple interpersonal traumatic events during childhood. Trial registrations: The study was registered on the "National Trial Register (NTR)" with the number NTR7024. This registry was obtained from the International Clinical Trial Registry Platform (ICTRP) and can be accessed through the ICTRP Search Portal (https://trialsearch.who.int/). [ABSTRACT FROM AUTHOR]

Background: A lifestyle including poor diet, physical inactivity, excessive gaming and inadequate sleep hygiene is frequently seen among Dutch children. These lifestyle behaviors can cause long-term health problems later in life. Unhealthy lifestyle and poor physical health are even more prevalent among children with mental illness (MI) such as autism, attention-deficit/hyperactivity disorder, depression, and anxiety. However, research on lifestyle interventions among children with MI is lacking. As a result, there are currently no guidelines, or treatment programs where children with MI and poor lifestyle can receive effective support. To address these issues and to provide insight into the effectiveness of lifestyle interventions in children with MI and their families, the Movementss study was designed. This paper describes the rationale, study design, and methods of an ongoing randomized controlled trial (RCT) comparing the short-term (12 weeks) and long-term (1 year) effects of a lifestyle intervention with care as usual (CAU) in children with MI and an unhealthy lifestyle. Methods: A total of 80 children (6–12 years) with MI according to DSM-V and an unhealthy lifestyle are randomized to the lifestyle intervention group or CAU at a specialized child and adolescent mental hospital. The primary outcome measure is quality of life measured with the KIDSCREEN. Secondary outcomes include emotional and behavior symptoms, lifestyle parameters regarding diet, physical activity, sleep, and screen time, cognitive assessment (intelligence and executive functions), physical measurements (e.g., BMI), parenting styles, and family functioning, prior beliefs, adherence, satisfaction, and cost-effectiveness. Assessments will take place at the start of the study (T0), after 12 weeks (T1), six months (T2), and 12 months of baseline (T3) to measure long-term effects. Discussion: This RCT will likely contribute to the currently lacking knowledge on lifestyle interventions in children with MI. Trial registration: trialsearch.who.int/ NL9822. Registered at November 2nd, 2021. [ABSTRACT FROM AUTHOR]

Background: Bulimia nervosa (BN) and binge eating disorder (BED) are eating disorders (EDs) characterized by recurrent binge eating. They are associated with medical complications, impaired adaptive function and often a high BMI, for which a multidisciplinary treatment approach may be needed. This study explored the efficacy of a novel intervention integrating Cognitive Behavioural Therapy- Enhanced (CBT-E) and weight management for people with recurrent binge eating episodes and high BMI with respect to physical, psychopathological and quality of life outcomes. Methods: Ninety-eight adults diagnosed with BN, BED, or Other Specified/Unspecified Feeding or Eating Disorder (OSFED/UFED) and BMI ≥ 27 to <40 kg/m2 were randomized to a multidisciplinary approach, the Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED) or to CBT-E. Metabolic parameters, health-related quality of life, general psychological and ED symptoms and ED diagnostic status outcomes are reported. Data were analyzed with mixed effects models adopting multiple imputed datasets where data were missing. Results: Both HAPIFED and CBT-E showed statistical significance for the time effect, with reduction in stress (p < 0.001), improvement in mental health-related quality of life (p = 0.032), reduction in binge eating severity (p < 0.001), and also in global ED symptoms scores (p < 0.001), with the significant changes found at end of treatment and sustained at 12-month follow-up. However, no statistical significance was found for differences between the interventions in any of the outcomes measured. Despite a high BMI, most participants (> 75%) had blood test results for glucose, insulin, triglycerides and cholesterol within the normal range, and 52% were within the normal range for the physical component of quality of life at baseline with no change during the trial period. Conclusion: Integrating weight and ED management resulted in comparable outcomes to ED therapy alone. Although adding weight management to an ED intervention had no adverse effects on psychological outcomes, it also had no beneficial effect on metabolic outcomes. Therefore, more intense weight management strategies may be required where indicated to improve metabolic outcomes. Safety will need to be concurrently investigated. Trial registration: US National Institutes of Health clinical trial registration number NCT02464345, date of registration 08/06/2015. Changes to the present paper from the published protocol paper (Trials 18:578, 2015) and as reported in the Trial registration (clinicaltrials.gov) are reported in Supplementary File 1. [ABSTRACT FROM AUTHOR]

Background: Though Internet- and mobile-based interventions (IMIs) and mindfulness-based interventions (generally delivered in-situ) appear effective for people with substance use disorders, IMIs incorporating mindfulness are largely missing, including those targeting frequent cannabis use. Methods: This paper details the protocol for a three-arm randomized controlled trial comparing a mindfulness-based self-help IMI (arm 1) and cognitive-behavioral therapy (CBT)-based self-help IMI (arm 2) versus being on a waiting list (arm 3) in their effectiveness reducing cannabis use in frequent cannabis users. Predictors of retention, adherence and treatment outcomes will be identified and similarities between the two active intervention arms explored. Both active interventions last six weeks and consist of eight modules designed to reduce cannabis use and common mental health symptoms. With a targeted sample size of n = 210 per treatment arm, data will be collected at baseline immediately before program use is initiated; at six weeks, immediately after program completion; and at three and six months post baseline assessment to assess the retention of any gains achieved during treatment. The primary outcome will be number of days of cannabis use over the preceding 30 days. Secondary outcomes will include further measures of cannabis use and use of other substances, changes in mental health symptoms and mindfulness, client satisfaction, intervention retention and adherence, and adverse effects. Data analysis will follow ITT principles and primarily employ (generalized) linear mixed models. Discussion: This RCT will provide important insights into the effectiveness of an IMI integrating mindfulness to reduce cannabis use in frequent cannabis users. Trial registration: International Standard Randomized Controlled Trial Number Registry: ISRCTN14971662; date of registration: 09/09/2021. [ABSTRACT FROM AUTHOR]

Background: Electroconvulsive therapy (ECT) has long been used for treating individuals with treatment-resistant depression (TRD). Esketamine has recently emerged as a new treatment for TRD due to its rapid antidepressant effects. To further inform the decision regarding choice of treatment, this paper aims to evaluate whether ECT or esketamine is the more cost-effective option. Methods: The cost-effectiveness was derived as cost per quality-adjusted life-year (QALY) using a Markov model from a societal and life-time perspective. The incremental cost-effectiveness ratio (ICER) was calculated. Health states included different depression and remission states and death. Data to populate the model was derived from randomised controlled trials and other research. Various sensitivity analyses were carried out to test the robustness of the model. Results: The base case scenario shows that ECT is cost-effective compared to esketamine and yields more QALYs at a lower cost. The sensitivity analysis shows that ECT is cost-effective in all scenarios and ECT dominates esketamine in 12 scenarios. Conclusions: This study found that, from a cost-effectiveness point of view, ECT should be the first-hand option for individuals with TRD, when other first line treatments have failed. Considering the lack of economic evaluation of ECT and esketamine, this study is of great value to decision makers. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is a highly prevalent mental disorder with large disease burden, high levels of relapse or persistence, and overall suboptimal outcomes of protocolized pharmacological and psychotherapeutic treatments. There is an urgent need to improve treatment effectiveness, possibly through systematic treatment personalization. In psychotherapeutic treatments this can be achieved by case conceptualization. To support this process, we developed the Therap-i module, which consists of personalized Experienced Sampling Methodology (ESM) and feedback. The Therap-i module is integrated into outpatient psychotherapeutic treatment as usual (TAU) for depression. The study aim is to investigate the efficacy of the Therap-i module in decreasing symptomatology in unresponsive or relapsing patients diagnosed with MDD. We hypothesize that the Therap-i module will contribute to TAU by i) decreasing depressive symptoms, and ii) improving general functioning, therapeutic working alliance, and illness perception. This paper provides details of the study rationale, aims, procedures, and a discussion on potential pitfalls and promises of the module. Methods: Patients diagnosed with MDD (n = 100) will enrol in a pragmatic two-armed randomized controlled trial. Randomization is stratified according to the patient's treatment resistance level assessed with the Dutch Method for quantification of Treatment Resistance in Depression (DM-TRD). All fill-out the Inventory of Depressive Symptomatology Self Report (IDS-SR), Outcome Questionnaire (OQ-45), Illness Perception Questionnaire Mental Health (IPQ-MH), and Work Alliance Inventory Self Report (WAI-SR). In the intervention arm, through close collaboration between patient, clinician, and researcher, a personalized ESM diary is developed based on the patient's case conceptualization. During the ESM monitoring period (8 weeks, 5 assessments/day), patients receive feedback three times, which is discussed among the abovementioned three parties. Both patients and clinicians will evaluate the Therap-i module. Results: Data collection is ongoing. Discussion: This is the first study in which personalized ESM and feedback is integrated in outpatient psychotherapeutic TAU for depression. The labour intensive procedure and methodological pitfalls are anticipated challenges and were taken into account when designing the study. When hypotheses are confirmed, the Therap-i module may advance treatment for depression by providing insights into personalized patterns driving or perpetuating depressive complaints. Trial registration: Trial NL7190 (NTR7381), registered prospectively 03-08-2018. [ABSTRACT FROM AUTHOR]

Background: Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients' recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontrolled clinical trials were conducted, with pre-post treatment and follow-up assessments. The results of these studies and subsequent replications showed an improvement in family attitudes and caregiver burnout. Our research team adapted FC for delivery in the Spanish population. We intend to test the efficacy of this program versus a treatment as usual condition. Moreover, we aim to test the efficacy of this program and study its effectiveness (in terms of participants' acceptance). This paper presents the study protocol. Methods: The study is a randomized controlled trial. The participants will be recruited in a Personality Disorders Unit and randomly assigned to one of two treatment conditions: Family Connections group (FC) or Treatment As Usual (TAU). Primary outcome measures will be the BAS and FAD-GFS. Secondary outcomes will include DASS-21, FES, GS, and QLI. Participants' treatment acceptance and degree of satisfaction will also be measured. Participants will be assessed at pre-, post-treatment, and 6-month follow-up. Intention to treat and per protocol analyses will be performed. Discussion: This is the first study on FC for relatives of people with borderline personality disorder (BPD) compared to an active condition (TAU), and this is the first time relatives' and patients' data will be analyzed. In addition, it is the first study to test the efficacy of the program in Spain. This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection. Trial registration: ClinicalTrials.gov ID: NCT04160871. Registered November 15th 2019. [ABSTRACT FROM AUTHOR]

Background: Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition. Methods: The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed. Discussion: This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial. Trial registration: The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019. [ABSTRACT FROM AUTHOR]

Objective: To assess the effectiveness of Internet-based self-help interventions in treating depression in adolescents and young adults. Methods: A systematic search was conducted across six databases, including PubMed, to identify randomized controlled trials (RCTs) that satisfied the specified inclusion and exclusion criteria. The intervention measure consisted of Internet-based self-help interventions. Results: A total of 23 randomized controlled trials (RCTs) were included in this analysis. Meta-analysis indicated that Internet-based self-help therapies significantly reduced depression scores in adolescents and young adults. (OR = -0.68, 95%CI [-0.88, -0.47], P < 0.001). We examined the effects of patient recruitment from various regions, medication usage, therapist involvement, weekly intervention time, and intervention duration. Patients selected from school, primary healthcare centers, clinics and local communities had better results. Intervention lasting 30 to 60 min and 60 to180 minutes per week were effective in the short term. Conclusion: The internet-based self-help intervention can be effective in treating depression in adolescents and young adults. However, factors such as patient recruitment locations, medication usage, Therapists' involvement, weekly intervention time, and intervention duration interacted with the outcome. Subgroup analysis on potential adverse effects and gender was impossible due to insufficient data from the included studies. [ABSTRACT FROM AUTHOR]

Background: Emotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assistance to all the people in need. Information and Communication Technologies can be very useful. This study aims to evaluate the efficacy of a transdiagnostic Internetbased treatment for ED in a community sample. The protocol includes traditional CBT components, as well as a specific component to address positive affect. We intend to test this protocol, including this specific component or not, versus a waiting list control group. Moreover, we aim to test the differential effect of this specific component, and study the effectiveness (in terms of patients' acceptance) of using a self-applied Internet-based program. This paper presents the study protocol. Methods: The study is a randomized controlled trial. 207 participants will be randomly assigned to: a) Transdiagnostic Internet-based protocol (TIBP), b)Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA), or c)a Waiting List control group (WL). Primary outcomes measures will be the BDI-II, the BAI, and the PANAS. Secondary outcomes will include diagnosis-specific measures of the principal disorder. Participants' treatment acceptance will also be measured. Participants will be assessed at pre-, post-treatment, and 3- and 12- month followups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. Discussion: To the best of our knowledge, this is the first study of a transdiagnostic Internet-based treatment for ED with a specific component to up-regulate positive affectivity. This intervention could contribute to improve the efficiency and effectiveness of current treatment programs for ED, promote the dissemination of EBTs, and help to decrease the high prevalence of ED. [ABSTRACT FROM AUTHOR]

Background: Postpartum depression is a disease with a prevalence of 20% that has deleterious consequences not only for the mother but also for the baby and can cause delays in physical, social and cognitive development. In this context, the European Union Committee on Public Health has declared it essential that preventative measures are taken by centres providing care for women with a multidisciplinary approach. PROGEA is a multicentre, single-blind randomized, 3-year, longitudinal clinical trial aiming to evaluate the efficacy of a psychoeducational programme in preventing postpartum depression in at-risk women, based on a range of clinical variables, and explore prognostic factors. This paper describes the methods and rationale behind the study. Methods: We will study women receiving treatment as usual plus a psychoeducation cognitive behavioural therapy (CBT)-based intervention and a control group receiving only treatment as usual. The sample will be recruited from an incidental sampling of pregnant women in two health regions. We will recruit 600 women in the third trimester of pregnancy who consent to take part in the study. Almost half of the women, about 280, would be expected to have some risk factors for postpartum depression. All those found to have risk factors will be evaluated, and we estimate that a quarter will be classified as at-risk of developing postpartum depression as measured with the Edinburgh Postnatal Depression Scale. This subset will be randomly allocated to receive treatment as usual with or without the CBT intervention. Six sessions of CBT (1 individual and 5 group) will be offered by a psychologist. Discussion: Findings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT-based intervention in improving the mood of women in the postpartum period. [ABSTRACT FROM AUTHOR]

Background: According to the World Alzheimer Report (Prince, The Global Impact of Dementia: an Analysis of Prevalence, Incidence, Cost and Trends, 2015), 46.8 million people worldwide are nowadays living with dementia. And this number is estimated to approximate 131.5 million by 2050, with an increasing burden on society and families. The lack of medical treatments able to stop or slow down the course of the disease has moved the focus of interest toward the nonpharmacological approach and psychosocial therapies for people with/at risk of dementia, as in the Mild Cognitive Impairment (MCI) condition. The purpose of the present study is to test an individualized home-based multidimensional program aimed at enhancing the continuum of care for MCI and outpatients with dementia in early stage using technology. Methods: The proposed study is a single blind randomized controlled trial (RCT) involving 30 subjects with MCI and Alzheimer's disease (AD) randomly assigned to the intervention group (Ability group), who will receive the "Ability Program", or to the active control group (ACG), who will receive "Treatment As Usual" (TAU). The protocol provides for three steps of assessment: at the baseline (T_0), after treatment, (T_1) and at follow-up (T_2) with a multidimensional evaluation battery including cognitive functioning, behavioral, functional, and quality of life measures. The Ability Program lasts 6 weeks, comprises tablet-delivered cognitive (5 days/week) and physical activities (7 days/week) combined with a set of devices for the measurement and monitoring from remote of vital and physical health parameters. The TAU equally lasts 6 weeks and includes paper and pencil cognitive activities (5 days/week), with clinician's prescription to perform physical exercise every day and to monitor selected vital parameters. Discussion: Results of this study will inform on the efficacy of a technology-enhanced home care service to preserve cognitive and motor levels of functioning in MCI and AD, in order to slow down their loss of autonomy in daily life. The expected outcome is to ensure the continuity of care from clinical practice to the patient's home, enabling also cost effectiveness and the empowerment of patient and caregiver in the care process, positively impacting on their quality of life. [ABSTRACT FROM AUTHOR]

Background: Adolescents are at risk of developing depressive symptoms. Given the prevalence, recurrence and negative consequences of adolescent depression, it is crucial to implement prevention programs for high-risk adolescents. Prevention programs at an indicated level have shown to be successful in reducing depressive symptoms in adolescents. This study will evaluate the (cost)effectiveness of the prevention program 'Op Volle Kracht (OVK 2.0)' for adolescents with elevated depressive symptoms. Methods: We will perform a Randomized Controlled Trial (RCT) with an intervention and control condition to test the effectiveness of an indicated prevention program aimed at depression in adolescents. Adolescents in their second year of secondary education (11-15 year) will be screened for depressive symptoms. Those with heightened levels of depressive symptoms (CDI-2 ≥ 14) will be randomly assigned to the intervention (N = 80) or control group (N = 80). The participants in the intervention condition will receive a prevention program comprising eight meetings of 60 min each. The participants in the control condition will receive psychoeducational information. All participants and their parents will complete assessment at baseline, post-intervention, and 6-, 12- and 24- month follow-up. Primary outcome will be depressive symptoms. Additionally, the present study will identify mechanisms that mediate and moderate the program effects and test the effect of OVK 2.0 on secondary outcomes. Discussion: This paper describes a study designed to screen adolescents for depressive symptoms and offer them a prevention program to prevent the onset of depressive symptomatology. Adolescents in the intervention condition are expected to show lower levels of depressive symptoms at 12 month follow-up compared to adolescents in the control condition. If OVK 2.0 proves to be effective, the screening and intervention program could be implemented in schools on a large scale. [ABSTRACT FROM AUTHOR]

Background: Approximately half of patients who seek care at Emergency Departments due to chest pain are diagnosed with Non-Cardiac Chest Pain (NCCP). Concerns for heart disease and misinterpretation of the symptoms increase cardiac anxiety and have a negative impact on patients' lives. Psychological interventions such as internet-delivered cognitive behavioral therapy (iCBT) are effective in treating psychological conditions such as anxiety, by helping patients to learn how to manage chest pain. Aims: To evaluate the effects of a nurse-led iCBT program on cardiac anxiety and secondary outcomes, as bodily sensations, depressive symptoms, health-related quality of life and chest pain frequency in patients with NCCP at 6- and 12-month follow-up, and to explore predictors that can have impact on the effects of the iCBT program on psychological distress. Methods: A longitudinal study of a Randomized Controlled Trial (RCT) evaluating the long-term effects of an iCBT program (n = 54) in patients with NCCP, compared to psychoeducation (n = 55). The primary outcome, cardiac anxiety was measured using the Cardiac Anxiety Questionnaire (CAQ), and the secondary outcomes were measured with The Body Sensations Questionnaire (BSQ), Patient Health Questionnaire-9 (PHQ-9), The EuroQol Visual Analog Scale (EQ-VAS) and a self-developed question to measure chest pain frequency. All measurements were performed before and after the intervention, and 3, 6 and 12 months after the intervention. Linear mixed model was used to test between-group differences in primary and secondary outcomes and multiple regression analysis was used to explore factors that may have an impact on the treatment effect of iCBT on cardiac anxiety. Results: A total of 85% (n = 93/109) participants completed the 12-month follow-up. Mixed model analysis showed no statistically significant interaction effect of time and group between the iCBT and psychoeducation groups regarding cardiac anxiety over the 12-month follow-up. However, there was a statistically significant interaction effect of time and group (p =.009) regarding chest pain frequency favouring the iCBT group. In addition, we found a group effect in health-related quality of life (p =.03) favouring the iCBT group. The regression analysis showed that higher avoidance scores at baseline were associated with improvement in cardiac anxiety at 12-month follow-up. Conclusions: Cardiac anxiety was reduced in patients with NCCP, but iCBT was not more effective than psychoeducation. Patients with a high tendency to avoid activities or situations that they believe could trigger cardiac symptoms may benefit more from psychological interventions targeting cardiac anxiety. Trial Registration: The trial was registered at ClinicalTrials.gov NCT03336112 on 08/11/2017. [ABSTRACT FROM AUTHOR]

Background: Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants. Methods: The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months. Discussion: The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed. [ABSTRACT FROM AUTHOR]

Background: Epidemiological studies suggest that compared with the general population, mood disorders are up to 4.7 times more prevalent in substance dependent samples. Comorbid substance use disorder (SUD) and depression has been associated with a more severe and protracted illness course and poorer treatment outcomes. Despite this, the development and assessment of behavioural interventions for treating depression among individuals with SUDs have received little empirical attention. Behavioural Activation Treatment for Depression (BATD-R) is an empirically supported treatment for depression that has shown some efficacy among substance users. This paper describes the study protocol of a parallel, single blind, randomised controlled trial to determine the efficacy and feasibility of a modified version of the BATD-R (Activate) in reducing symptoms of depression and substance dependence among individuals in residential rehabilitation (RR) and opioid substitution therapy (OST). Methods/design: A sample of approximately 200 individuals with depressive symptomatology in treatment for SUD will be recruited from RR and OST services in New South Wales, Australia. Dynamic random allocation following minimisation methodology will be used to assign participants to one of two groups. The control group will receive treatment as usual (TAU), which will be the model of care provided in accordance with standard practice at participating RR and OST services. The intervention group will receive Activate, comprising 10 individual 60-min therapy sessions with a psychologist employed on the research team, in addition to TAU. Data collection will occur at baseline (pre-intervention), and 3-months and 12-months post baseline. Discussion: The association between depression and substance dependence has been well documented, yet practical and effective treatments are scarce. The findings of the present study will contribute significantly to understanding the types of programs that are effective in treating this comorbidity. [ABSTRACT FROM AUTHOR]

Background: Government policy encourages increasing involvement of patients in their long-term care. This paper describes the development and pilot evaluation of a 'Medication Review Tool' designed to assist people to participate more effectively in discussions about antipsychotic drug treatment. Methods: The Medication Review Tool developed consisted of a form to help patients identify pros and cons of their current antipsychotic treatment and any desired changes. It was associated with a website containing information and links about antipsychotics. For the trial, participants diagnosed with psychotic disorders were recruited from community mental health services. Cluster randomisation was used to allocate health professionals (care co-ordinators) and their associated patients to use of the Medication Review Tool or usual care. All participants had a medical consultation scheduled, and those in the intervention group completed the Medication Review Tool, with the help of their health professional prior to this, and took the completed Form into the consultation. Two follow-up interviews were conducted up to three months after the consultation. The principal outcome was the Decision Self Efficacy Scale (DSES). Qualitative feedback was collected from patients in the intervention group. Results: One hundred and thirty patients were screened, sixty patients were randomised, 51 completed the first follow-up assessment and 49 completed the second. Many patients were not randomised due to the timing of their consultation, and involvement of health professionals was inconsistent. There was no difference between the groups on the DSES (-4.16 95 % CI -9.81, 1.49), symptoms, side effects, antipsychotic doses or patient satisfaction. Scores on the Medication Adherence Questionnaire indicated an increase in participants' reported inclination to adherence in the intervention group (coefficient adjusted for baseline values -0.44; 95 % CI -0.76, -0.11), and there was a small increase in positive attitudes to antipsychotic medication (Drug Attitude Inventory, adjusted coefficient 1.65; 95 % CI -0.09, 3.40). Qualitative feedback indicated patients valued the Tool for identifying both positive and negative aspects of drug treatment. Conclusions: The trial demonstrated the design was feasible, although challenges included service re-configurations and maintaining health professional involvement. Results may indicate a more intensive and sustained intervention is required to facilitate participation in decision-making for this group of patients. [ABSTRACT FROM AUTHOR]

Background: In this paper, we present the protocol for a cluster-randomised trial to evaluate the implementation and effectiveness of a workplace mental health intervention in the state-wide police department of the southeastern Australian state of Victoria. n. The primary aims of the intervention are to improve psychosocial working conditions and mental health literacy, and secondarily to improve mental health and organisational outcomes. Methods/design: The intervention was designed collaboratively with Victoria Police based on a mixed methods pilot study, and combines multi-session leadership coaching for the senior officers within stations (e.g., Sergeants, Senior Sergeants) with tailored mental health literacy training for lower and upper ranks. Intervention effectiveness will be evaluated using a two-arm cluster-randomised trial design, with 12 police stations randomly assigned to the intervention and 12 to the non-intervention/usual care control condition. Data will be collected from all police members in each station (estimated at >20 per station). Psychosocial working conditions (e.g., supervisory support, job control, job demands), mental health literacy (e.g., knowledge, confidence in assisting someone who may have a mental health problem), and mental health will be assessed using validated measures. Organisational outcomes will include organisational depression disclosure norms, organisational cynicism, and station-level sickness absence rates. The trial will be conducted following CONSORT guidelines. Identifying data will not be collected in order to protect participant privacy and to optimise participation, hence changes in primary and secondary outcomes will be assessed using a two-sample t-test comparing summary measures by arm, with weighting by cluster size. Discussion: This intervention is novel in its integration of stressor-reduction and mental health literacy-enhancing strategies. Effectiveness will be rigorously evaluated, and if positive results are observed, the intervention will be adapted across Victoria Police (total employees ~16,500) as well as possibly in other policing contexts, both nationally and internationally. Trial registration: Current Controlled Trials: ISRCTN82041334. Registered 24th July, 2014. [ABSTRACT FROM AUTHOR]

Background: Anxiety disorders are among the most prevalent psychiatric conditions, and are associated with poor quality of life and substantial economic burden. Cognitive behavioural therapy is an effective treatment to reduce anxiety symptoms, but is also costly and labour intensive. Cost-effectiveness could possibly be improved by delivering cognitive behavioural therapy in a blended format, where face-to-face sessions are partially replaced by online sessions. The aim of this trial is to determine the cost-effectiveness of blended cognitive behavioural therapy for adults with anxiety disorders, i.e. panic disorder, social phobia or generalized anxiety disorder, in specialized mental health care settings compared to face-to-face cognitive behavioural therapy. In this paper, we present the study protocol. It is hypothesized that blended cognitive behavioural therapy for anxiety disorders is clinically as effective as face-to-face cognitive behavioural therapy, but that intervention costs may be reduced. We thus hypothesize that blended cognitive behavioural therapy is more cost-effective than face-to-face cognitive behavioural therapy. Methods/design: In a randomised controlled equivalence trial 156 patients will be included (n = 78 in blended cognitive behavioural therapy, n = 78 in face-to-face cognitive behavioural therapy) based on a power of 0.80, calculated by using a formula to estimate the power of a cost-effectiveness analysis: n=... Measurements will take place at baseline, midway treatment (7 weeks), immediately after treatment (15 weeks) and 12-month follow-up. At baseline a diagnostic interview will be administered. Primary clinical outcomes are changes in anxiety symptom severity as measured with the Beck Anxiety Inventory. An incremental costeffectiveness ratio will be calculated to obtain the costs per quality-adjusted life years (QALYs) measured by the EQ-5D (5-level version). Health-economic outcomes will be explored from a societal and health care perspective. Discussion: This trial will be one of the first to provide information on the cost-effectiveness of blended cognitive behavioural therapy for anxiety disorders in routine specialized mental health care settings, both from a societal and a health care perspective. [ABSTRACT FROM AUTHOR]

Background: Mental Health First Aid (MHFA) training teaches community members how to provide initial support to someone with a mental health problem. Key gaps in the evidence base supporting the training are the longevity of effects beyond 6 months, effects on mental health first aid behavior, and the impact of support on the recipient of aid. This study aimed to evaluate the effect of the Youth MHFA course 3 years after training. Methods: 384 Australian parents of an adolescent aged 12–15 were randomized to receive either the 14-h Youth MHFA course or the 15-h Australian Red Cross Provide First Aid course. This paper reports outcomes at baseline and 3 years later. Primary outcomes were cases of adolescent mental health problems, and parental support towards their adolescent if they developed a mental health problem, rated by the parent and adolescent. Secondary outcomes included parent knowledge about youth mental health problems, intentions and confidence in supporting a young person, stigmatizing attitudes, and help-seeking for mental health problems. Data were analyzed with mixed-effects models with group by measurement occasion interactions. Results: 3-year follow-up data was obtained from 149 parents and 118 adolescents, who were aged 16.5 years on average. Between baseline and 3-year follow-up, there was a non-significant reduction in adolescent cases of mental health problems relative to the control group (odds ratios (OR) 0.16–0.17), a non-significant improvement in parental support reported by adolescents with a mental health problem (OR 2.80–4.31), and a non-significant improvement in the quality of support that parents reported providing to their adolescents with a mental health problem (d = 0.38). Secondary outcomes that showed significant improvements relative to the control group were parental knowledge about youth mental health problems (d = 0.31) and adolescent perceptions of general social support from their parents (d = 0.35). Conclusions: This paper reports on the longest follow-up of Mental Health First Aid training in a controlled trial. Three years after training, participants had maintained their improved knowledge about mental health problems. There were some indications of other positive effects, but the study was underpowered to clearly show benefits to mental health first aid skills and recipients of aid. Trial registration: ACTRN12612000390886, registered retrospectively 5/4/2012, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347502 [ABSTRACT FROM AUTHOR]

Background: In the clinical setting, a large proportion of children with an autism spectrum disorder (ASD) experience anxiety symptoms. Because anxiety is an important cause of impairment for children with an ASD, it is necessary that effective anxiety interventions are implemented for these children. Recently, a serious game called Mindlight has been developed that is focused on decreasing anxiety in children. This approach is based on recent research suggesting that video games might be suitable as an intervention vehicle to enhance mental health in children. In the present study it will be investigated whether Mindlight is effective in decreasing (sub) clinical anxiety symptoms in children who are diagnosed with an ASD. Methods/Design: The present study involves a randomized controlled trial (RCT) with two conditions (experimental versus control), in which it is investigated whether Mindlight is effective in decreasing (sub) clinical anxiety symptoms in children with an ASD. For this study, children of 8-16 years old with a diagnosis of an ASD and (sub) clinical anxiety symptoms will be randomly assigned to the experimental (N = 60) or the control (N = 60) condition. Children in the experimental condition will play Mindlight for one hour per week, for six consecutive weeks. Children in the control condition will play the puzzle game Triple Town, also for one hour per week and for six consecutive weeks. All children will complete assessments at baseline, post-intervention and 3-months follow-up. Furthermore, parents and teachers will also complete assessments at the same time points. The primary outcome will be child report of anxiety symptoms. Secondary outcomes will be parent report of child anxiety, child/parent report of depressive symptoms, and parent/teacher report of social functioning and behavior problems. Discussion: This paper aims to describe a study that will examine the effect of the serious game Mindlight on (sub) clinical anxiety symptoms of children with an ASD in the age of 8-16 years old. It is expected that children in the experimental condition will show lower levels of anxiety symptoms at 3-months follow-up, compared to children in the control condition. If Mindlight turns out to be effective, it could be an important contribution to the already existing interventions for anxiety in children with an ASD. Mindlight could then be implemented as an evidence-based treatment for anxiety symptoms in children with an ASD in mental health institutes and special education schools. [ABSTRACT FROM AUTHOR]

Background: Despite widespread popularity, text messaging has rarely been used for data collection in clinical research. This paper reports on the development, feasibility, acceptability, validity, and discriminant utility of a single item depression rating scale, delivered weekly via an automated SMS system, as part of a large randomised controlled trial. Methods: 755 depressed patients (BDI-II score ≥20) were recruited from primary care into a randomised trial of acupuncture versus counselling or usual care, and invited to opt into a repeated-measures text messaging sub-study. Two weeks following random allocation, trial participants were sent a weekly text message for 15 weeks. Texts were a single question asking, on a scale from 1 to 9, the extent to which they felt depressed. Feasibility and acceptability of the automated SMS system were evaluated according to cost, ease of implementation, proportion consenting, response rates, and qualitative feedback. Concurrent validity was estimated by correlating SMS responses with the Patient Health Questionnaire (PHQ-9). SMS responses were compared between groups over time to explore treatment effects. Results: 527 (69.8%) trial participants consented to the texting sub-study, of whom 498 (94.5%) responded to at least one message. Participants provided a valid response to an average of 12.5 messages. Invalid responses accounted for 1.1% of texts. The automated SMS system was quick to set-up, inexpensive, and well received. Comparison of PHQ-9 and SMS responses at 3 months demonstrated a moderate to high degree of agreement (Kendall's tau-b = 0.57, p < 0.0001, n = 220). SMS depression scores over the 15 weeks differed significantly between trial arms (p = 0.007), with participants allocated to the acupuncture and counselling arms reporting improved depression outcomes compared to usual GP care alone, which reached statistical significance ten weeks after randomisation. Overall, the single item SMS scale also appeared more responsive to changes in depression, resulting from treatment, than the PHQ-9. Conclusions: Automated SMS systems offer a feasible and acceptable means of monitoring depression within clinical research. This study provides clear evidence to support the regular use of a simple SMS scale as a sensitive and valid outcome measure of depression within future randomised controlled trials. [ABSTRACT FROM AUTHOR]

Background: The impact of mental health problems and disorders in Australia is significant. Mental health problems often start early and disproportionately affect young people. Poor adolescent mental health can predict educational achievement at school and educational and occupational attainment in adulthood. Many young people attend higher education and have been found to experience a range of mental health issues. The university setting therefore presents a unique opportunity to trial interventions to reduce the burden of mental health problems. Mental Health First Aid (MHFA) aims to train participants to recognise symptoms of mental health problems and assist an individual who may be experiencing a mental health crisis. Training nursing students in MHFA may increase mental health literacy and decrease stigma in the student population. This paper presents a protocol for a trial to examine the efficacy of the MHFA training for students studying nursing at a large university in Perth, Western Australia. Methods/Design: This randomised controlled trial will follow the CONSORT guidelines. Participants will be randomly allocated to the intervention group (receiving a MHFA training course comprising two face to face 6.5 hour sessions run over two days during the intervention period) or a waitlisted control group (not receiving MHFA training during the study). The source population will be undergraduate nursing students at a large university located in Perth, Western Australia. Efficacy of the MHFA training will be assessed by following the intention-to-treat principle and repeated measures analysis. Discussion: Given the known burden of mental health disorders among student populations, it is important universities consider effective strategies to address mental health issues. Providing MHFA training to students offers the advantage of increasing mental health literacy, among the student population. Further, students trained in MHFA are likely to utilise these skills in the broader community, when they graduate to the workforce. It is anticipated that this trial will demonstrate the scalability of MHFA in the university environment for pre-service nurses and that implementation of MHFA courses, with comprehensive evaluation, could yield positive improvements in the mental health literacy amongst this target group as well as other tertiary student groups. [ABSTRACT FROM AUTHOR]

Background: A substantial proportion of people with bipolar disorder (BD) experience persistent cognitive difficulties associated with impairments in psychosocial functioning and a poorer disorder course. Emerging evidence suggests that cognitive remediation (CR), a psychological intervention with established efficacy in people with schizophrenia, can also benefit people with BD. Following a proof-of-concept trial showing that CR is feasible and potentially beneficial for people with BD, we are conducting an adequately powered trial in euthymic people with BD to 1) determine whether an individual, therapist-supported, computerised CR can reduce cognitive difficulties and improve functional outcomes; and 2) explore how CR exerts its effects. Methods: CRiB2 is a two-arm, assessor-blind, multi-site, randomised controlled trial (RCT) comparing CR to treatment-as-usual (TAU). Participants are people with a diagnosis of BD, aged between 18 and 65, with no neurological or current substance use disorder, and currently euthymic. 250 participants will be recruited through primary, secondary, tertiary care, and the community. Participants will be block-randomised (1:1 ratio, stratified by site) to continue with their usual care (TAU) or receive a 12-week course of therapy and usual care (CR + TAU). The intervention comprises one-on-one CR sessions with a therapist supplemented with independent cognitive training for 30–40 h in total. Outcomes will be assessed at 13- and 25-weeks post-randomisation. Efficacy will be examined by intention-to-treat analyses estimating between-group differences in primary (i.e., psychosocial functioning at week 25 measured with the Functional Assessment Short Test) and secondary outcomes (i.e., measures of cognition, mood, patient-defined goals, and quality of life). Global cognition, metacognitive skills, affect fluctuation, and salivary cortisol levels will be evaluated as putative mechanisms of CR through mediation models. Discussion: This study will provide a robust evaluation of efficacy of CR in people with BD and examine the putative mechanisms by which this therapy works. The findings will contribute to determining the clinical utility of CR and potential mechanisms of action. Trial registration: Cognitive Remediation in Bipolar 2 (CRiB2): ISRCTN registry: https://www.isrctn.com/ISRCTN10362331. Registered 04 May 2022. Overall trial status: Ongoing; Recruitment status: Recruiting. [ABSTRACT FROM AUTHOR]

Background: Self-harm in young people is a public health concern connected with severe mental health problems, such as personality pathology. Currently, there are no specific evidence-based interventions available for young people who self-harm. Therefore, we developed PRe-Intervention Monitoring of Affect and Relationships in Youth (PRIMARY), a smartphone-based intervention, co-designed by clinicians and young people with lived experience of mental ill-health. PRIMARY combines the Experience Sampling Method (ESM) with weekly report sessions. The study aims to examine the effectiveness of PRIMARY with regard to reducing self-harm, and improving emotion regulation and quality of relationships. Methods: This study is a multicenter, parallel groups, randomized controlled trial (RCT) comparing the PRIMARY intervention to a waiting list control group. PRIMARY comprises 28 consecutive days of questionnaires five times each day (i.e., ESM) and four weekly report sessions. Participants will comprise 180 young people referred for treatment to the participating Dutch mental healthcare institutions and (1) are aged 12 to 25 years, and (2) engaged in ≥ 1 act of self-harm in the past year. Participants are randomly allocated to a study group after screening in a 1:1 ratio by an independent researcher using computer-generated randomization sequences with stratified block randomization by age (12 to 15 years / 16 to 25 years). Staff will conduct assessments with all participants at baseline (Wave 1), after 28 days (Wave 2), and in a subsample after 10 weeks of subsequent specialized treatment (Wave 3). The primary outcomes are self-harm, emotion regulation, and quality of relationships. Secondary outcomes include patient and clinician satisfaction. Exploratory analyses of ESM data will examine the relationship between emotions, social relationships, and self-harm. Discussion: The results of this trial will clarify whether an innovative smartphone-based intervention is effective for reducing self harm and improving emotion regulation and the quality of social relationships. It has the potential to fill a treatment gap of interventions specifically targeting self-harm. If proven effective, it would provide an accessible, easy-to-implement, low-cost intervention for young people. Furthermore, the ESM-data will allow detailed analyses into the processes underlying self-harm, which will contribute to theoretical knowledge regarding the behavior. Trial registration: ISRCTN42088538 (https://doi.org/10.1186/ISRCTN42088538), retrospectively registered on the 26th of October 2022. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has negatively affected the mental health of international migrant workers (IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters in times of stress (DWM), a guided self-help web application, and Problem Management Plus (PM +), a brief facilitator-led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped-care programme (DWM/PM +) is effective and cost-effective in reducing psychological distress, among Polish migrant workers with psychological distress living in the Netherlands. Methods: The stepped-care DWM/PM + intervention will be tested in a two-arm, parallel-group, randomized controlled trial (RCT) among adult Polish migrant workers with self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15.9). Participants (n = 212) will be randomized into either the intervention group that receives DWM/PM + with psychological first aid (PFA) and care-as-usual (enhanced care-as-usual or eCAU), or into the control group that receives PFA and eCAU-only (1:1 allocation ratio). Baseline, 1-week post-DWM (week 7), 1-week post-PM + (week 13), and follow-up (week 21) self-reported assessments will be conducted. The primary outcome is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes are self-reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD), resilience, quality of life, and cost-effectiveness. In a process evaluation, stakeholders' views on barriers and facilitators to the implementation of DWM/PM + will be evaluated. Discussion: To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interventions into a stepped-care programme for migrant populations. If proven to be effective, this may bridge the mental health treatment gap IMWs experience. Trial registration: Dutch trial register NL9630, 20/07/2021, https://www.onderzoekmetmensen.nl/en/trial/27052 [ABSTRACT FROM AUTHOR]

Background: Treatment of adults with attention-deficit/hyperactivity disorder (ADHD) primary involves methylphenidate (MPH). Earlier studies have identified placebo responders to increase toward the end of the treatment periods. However, little is known about the immediate effects of placebo on the core symptoms of ADHD in adults. The present study aimed to examine the effects of one single-dose MPH compared to one single-dose placebo during clinical assessments with continuous performance tests (CPT). Methods: In a randomized study with cross-over design, 40 adults between 19 and 64 years (72.5% women) with untreated ADHD were consecutively enrolled. The study comprised two trial days with four days in between. The QbTest was performed twice on the same day, before and 80 min after intake of one single-dose 20 mg immediate release methylphenidate (IR-MPH) and with one single-dose placebo, in randomized order. Results: Performance improved in QbInattention, F (3, 117) = 38.25, p < 0.001, after given IR-MPH (mean diff = 1.14) and after placebo (mean diff = 0.60) with the effect sizes 1.17 and 0.63 respectively. IR-MPH improved performance in QbActivity (mean diff = 0.81, p < 0.001) and QbImpulsivity (mean diff = 0.46, p < 0.04). The proportion of improvements (a decrease by ≥ 0.5 Qb-score) in the parameters QbInattention, QbActivity and QbImpulsivity were 90%, 60% and 52.5%, respectively. After given placebo, corresponding proportions were 60%, 30% and 35%, respectively. Conclusions: There seems to be an immediate placebo response in the core symptom inattention. The effect of placebo cannot be ruled out and must be taken in consideration during drug trials with continuous performance tests (CPTs). Trial registration: ClinicalTrials.gov; Identifier: NCT02473185. [ABSTRACT FROM AUTHOR]

Background: Non-cardiac chest pain is common and associated with increased anxiety and reduced health-related quality of life. Randomized controlled trials on psychological interventions for patients with non-cardiac chest pain have reported mixed results. Patients with non-cardiac chest pain are a heterogeneous group. Identifying sub-groups that could potentially benefit more (or less) from an intervention would be valuable knowledge. We have conducted a randomized controlled trial where internet-based cognitive behavioural therapy (iCBT) had effect on reducing cardiac anxiety and increasing health-related quality of life at 12-month follow-up. The aim of the present study was to explore potential effect modifiers of iCBT in patients with non-cardiac chest pain on cardiac anxiety and/or health related quality of life at 12-month follow-up. Methods: We analysed data from our randomized, controlled trial where 161 patients with non-cardiac chest pain were included and randomized to either iCBT or a treatment as usual (control). Cardiac anxiety measured by the Cardiac Anxiety Questionnaire and health-related quality of life measured by the EuroQol Visual Analog Scale at 12 month follow-up were the primary outcomes. Four potential baseline characteristics where identified as potential effect modifiers by a theory-based approach: (1) depression measured by the Patient Health Questionnaire; (2) anxiety measured by the Body Sensations Questionnaire; (3) prior healthcare contacts measured by a self-developed question; and (4) chest pain frequency measured by a self-developed question. Each potential effect modifier was analysed in a linear regression model where cardiac anxiety and EQ-VAS scores at 12-month follow-up, separately, were used as dependent variables. The potential differential treatment effect for each effect modifier was assessed by the interaction term: effect modifier x treatment group. Results: Depression symptoms at baseline predicted a differential treatment effect at 12-month follow-up on health-related quality of life in favor of the iCBT group (regression coefficient of the interaction term: -1.85 (CI -3.28 to -0.41), p = 0.01), but not on cardiac anxiety at 12-month follow-up. Fear of bodily symptoms, chest pain frequency and prior health care contacts at baseline did not predict a treatment effect on either health-related quality of life or cardiac anxiety. Conclusions: Depression symptoms at baseline predicted a positive treatment effect of iCBT on health-related quality of life in patients suffering from non-cardiac chest pain. This indicates that it is important to identify patients with non-cardiac chest pain and co-occurring depression symptoms given that they are particularly likely to benefit from iCBT. Trial registration: ClinicalTrials.gov NCT03096925. [ABSTRACT FROM AUTHOR]

Background: In children with early-onset anorexia nervosa (first symptoms before 13 years old, EO-AN), experts recommend initial outpatient treatment but in-patient treatment (IP) is frequently indicated due to acute medical instability or for those who have not improved with outpatient treatment. This IP can target either a partial weight restauration or a total weight normalization (return to the previous BMI growth trajectory). There are no evidence in the literature on which is the better therapeutic option in EOAN. But as long length of stay induce social isolation, with elevated costs, we wonder if a stepped-care model of daypatient treatment (DP) after short IP stabilisation may be a treatment option as effective as full-time IP to target weight normalization. We designed a two-arm randomised controlled trial testing the non-inferiority of a stepped-care model of DP after short IP stabilisation versus full-time IP. Methods: Eighty-eight children aged 8 to 13 years suffering from EOAN with initial severe undernutrition will be randomly allocated to either IP treatment as usual or a stepped care DP model both targeting weight normalization. Assessments will be conducted at inclusion, somatic stabilization, weight normalization, 6 months and 12 months post randomisation. The primary outcome will be BMI at 12 months post-randomisation. Secondaries outcomes will included clinical (tanner stage), biological (prealbumin, leptin, total ghrelin and IGF1) and radiological (bone mineralization and maturation) outcomes, eating symptomatology and psychiatric assessments, motivation to change, treatment acceptability and quality of life assessments, cost-utility and cost-effectiveness analyses. Discussion: COTIDEA will provide rigorous evaluation of treatment alternative to full-time inpatient treatment to allow a reduction of social iatrogenic link to hospital length of stay and associated costs. Trial registration: Trial is registered on ClinicalTrials.gov (NCT04479683). [ABSTRACT FROM AUTHOR]

Background: Prospective memory is important for our health and independence but declines with age. Hence, interventions to enhance prospective memory, for example by providing an incentive, may promote healthy ageing. The neuroanatomical correlates of prospective memory and the processing of incentive-related prospective memory changes in older adults are not fully understood. In an fMRI study, we will therefore test whether incentives improve prospective memory in older adults and how prospective memory is processed in the brain in general, and when incentives are provided. Since goals and interests change across adulthood, avoiding losses is becoming more important for older adults than achieving gains. We therefore posit that loss-related incentives will enhance prospective memory, which will be subserved by increased prefrontal and midbrain activity. Methods: We will include n = 60 healthy older adults (60–75 years of age) in a randomized, single-blind, and parallel-group study. We will acquire 7T fMRI data in an incentive group and a control group (n = 30 each, stratified by education, age, and sex). Before and after fMRI, all participants will complete questionnaires and cognitive tests to assess possible confounders (e.g., income, personality traits, sensitivity to reward or punishment). Discussion: The results of this study will clarify whether loss-related incentives can enhance prospective memory and how any enhancement is processed in the brain. In addition, we will determine how prospective memory is processed in the brain in general. The results of our study will be an important step towards a better understanding of how prospective memory changes when we get older and for developing interventions to counteract cognitive decline. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

Background: Sleep is necessary for healthy development and mental wellbeing. Despite this, many children do not get the recommended duration of sleep each night, and many experience sleep problems. Although treatable, existing interventions for sleep disturbance are time-consuming, burdensome for families, and focus on providing behavioural strategies to parents rather than upskilling children directly. To address this gap, we modified Sleep Ninja®, an evidence-based cognitive behavioural therapy for insomnia (CBT-I) smartphone app for adolescent sleep disturbance, to be appropriate for 10 to 12 year olds. Here, we describe the protocol for a randomised controlled trial to evaluate the effect of Sleep Ninja on insomnia and other outcomes, including depression, anxiety, sleep quality, and daytime sleepiness, and explore effects on the emergence of Major Depressive Disorder (MDD), compared to an active control group. Methods: We aim to recruit 214 children aged 10 to 12 years old experiencing disturbed sleep. Participants will be screened for inclusion, complete the baseline assessment, and then be randomly allocated to receive Sleep Ninja, or digital psychoeducation flyers (active control) for 6-weeks. The primary outcome, insomnia symptoms, along with depression, anxiety, sleep quality, and daytime sleepiness will be assessed at 6-weeks (primary endpoint), 3-months, and 9-months post-baseline (secondary and tertiary endpoints, respectively). A mixed model repeated measures analytic approach will be used to conduct intention-to-treat analyses to determine whether reductions in insomnia and secondary outcomes are greater for those receiving Sleep Ninja relative to the control condition at the primary and secondary endpoints. The difference in relative risk for MDD onset will be explored at 9-months and compared between conditions. Discussion: This is the first clinical trial examining the effects of a CBT-I smartphone app in children experiencing sleep disturbance. Results will provide empirical evidence about the effects of Sleep Ninja on insomnia and other mental health outcomes. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12623000587606). Universal Trial Number: U1111-1294-4167. [ABSTRACT FROM AUTHOR]

Background: Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. Methods: The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated. Discussion: The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. Trial registration: Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271–9928. [ABSTRACT FROM AUTHOR]

Background: In recent years, whether, when and how to use antidepressants to treat depressive disorder in children and adolescents has been hotly debated. Relevant evidence on this topic has increased rapidly. In this paper, we present the construction and content of a database of randomised controlled trials of antidepressants to treat depressive disorder in children and adolescents. This database can be freely accessed via our website and will be regularly updated. Description: Major bibliographic databases (PubMed, the Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO and LiLACS), international trial registers and regulatory agencies' websites were systematically searched for published and unpublished studies up to April 30, 2017. We included randomised controlled trials in which the efficacy or tolerability of any oral antidepressant was compared with that of a control group or any other treatment. In total, 7377 citations from bibliographical databases and 3289 from international trial registers and regulatory agencies' websites were identified. Of these, 53 trials were eligible for inclusion in the final database. Selected data were extracted from each study, including characteristics of the participants (the study population, setting, diagnostic criteria, type of depression, age, sex, and comorbidity), characteristics of the treatment conditions (the treatment conditions, general information, and detail of pharmacotherapy and psychotherapy) and study characteristics (the sponsor, country, number of sites, blinding method, sample size, treatment duration, depression scales, other scales, and primary outcome measure used, and side-effect monitoring method). Moreover, the risk of bias for each trial were assessed. Conclusion: This database provides information on nearly all randomised controlled trials of antidepressants in children and adolescents. By using this database, researchers can improve research efficiency, avoid inadvertent errors and easily focus on the targeted subgroups in which they are interested. For authors of subsequent reviews, they could only use this database to insure that they have completed a comprehensive review, rather than relied solely on the data from this database. We expect this database could help to promote research on evidence-based practice in the treatment of depressive disorder in children and adolescents. The database could be freely accessed in our website: http://xiepengteam.cn/research/evidence-based-medicine. [ABSTRACT FROM AUTHOR]

Background: Cognitive training shows promising effects for improving cognitive domains in individuals with mild cognitive impairment (MCI), including the crucial predictive factor of executive function (EF) for dementia prognosis. Few studies have paid sufficient emphasis on the training-induced effects of cognitive training programs, particularly with regards to targeting EF. A process-based multi-task adaptive cognitive training (P-bM-tACT) program targeting EF is required to examine direct, transfer, and sustainability effects in older adults with MCI. Objective: This study aimed to evaluate the direct effects of a P-bM-tACT program on EF, the transfer effects on untrained cognitive domains, and further explore the sustainability of training gains for older adults with MCI in the community. Methods: In a single-blind, randomized controlled trial, 92 participants with MCI were randomly assigned to either the intervention group, participating in a P-bM-tACT program (3 training sessions/week, 60 min/session for 10 weeks) or the wait-list control group, accepting a health education program on MCI (1 education session/ twice a week, 40–60 min/session for 10 weeks). The direct and transfer effects of the P-bM-tACT program were assessed at baseline, immediately after 10 weeks of training, and the 3-month follow-up. Repeated measures analysis of variance and a simple effect test were used to compare the direct and transfer effects over the 3-time points between the two groups. Results: The P-bM-tACT program yielded a greater benefit of direct and transfer effects in the intervention group participants than in the wait-list control group. Combined with the results of simple effect tests, the direct and transfer effects of participants in the intervention group significantly increased immediately after 10 weeks of training compared to the baseline (F = 14.702 ~ 62.905, p < 0.05), and these effects were maintained at the 3-month follow-up (F = 19.595 ~ 122.22, p < 0.05). Besides, the acceptability of the cognitive training program was established with a high adherence rate of 83.4%. Conclusions: The P-bM-tACT program exerted positive direct and transfer effects on the improvement of cognitive function, and these effects were sustained for 3 months. The findings provided a viable and potential approach to improving cognitive function in older adults with MCI in the community. Trial registration: The trial was registered at Chinese Clinical Trials Registry on 09/01/2019 (www.chictr.org.cn; Number Registry: ChiCTR1900020585). [ABSTRACT FROM AUTHOR]

Background: Activity and participation are critical to health and wellbeing. Limited evidence exists on how to support people with mental illness in participating in everyday activities. Aim: To investigate the effectiveness of Meaningful Activities and Recovery (MA&R), a co-led peer occupational therapy intervention focusing on activity engagement, functioning, quality of life, and personal recovery. Methods: In a statistician blinded, multicenter RCT including 139 participants from seven community and municipal mental health services in Denmark, participants were randomly assigned to 1) MA&R and standard mental health care or 2) standard mental health care. The MA&R intervention lasted 8 months and consisted of 11 group sessions, 11 individual sessions, and support to engage in activities. The primary outcome, activity engagement, was measured using Profile of Occupational Engagement in People with Severe Mental Illness (POES-S). Outcomes were measured at baseline and post-intervention follow-up. Results: Meaningful Activities and Recovery was delivered with high fidelity and 83% completed the intervention. It did not demonstrate superiority to standard mental health care, as intention-to treat analysis revealed no significant differences between the groups in activity engagement or any of the secondary outcomes. Conclusion: We did not find positive effects of MA&R, possibly because of COVID-19 and related restrictions. Fidelity assessments and adherence rates suggest that MA&R is feasible and acceptable. However, future studies should focus on refining the intervention before investigating its effectiveness. Trial registration: The trial was registered 24/05/2019 at ClinicalTrials.gov NCT03963245. [ABSTRACT FROM AUTHOR]

Background: Hypothyroidism is the most common clinical disorder of the thyroid gland which is associated with an increased prevalence of sexual dysfunction even if treated with medication. Objective: The aim of this study was to determine the effect of cognitive-behavioral therapy (CBT) on sexual function in reproductive-aged women with hypothyroidism. Materials and methods: This randomized clinical trial was performed on 66 reproductive-aged women with hypothyroidism referring to selected health centers in Izeh, Iran. Data collection tools included demographic information form and Female Sexual Function Index (FSFI). Eligible individuals were randomly assigned to case (n = 33) and control (n = 33) groups using block randomization with the block size of 4. In addition to standard hypothyroidism treatment, the case group received 8 sessions of cognitive-behavioral group therapy, while the control group received only standard treatment. Results: Before of treatment, there was no significant difference between the mean score of sexual function and its dimensions between the case and control groups (p < 0.05). However, immediately and 4 weeks after completion of treatment, the mean total score of sexual function and its dimensions in the case group increased significantly compared to the control group (p < 0.001). Conclusion: According to the results of this study, CBT can be effective in improving sexual dysfunction in reproductive-aged women with hypothyroidism. However, before recommending this therapy to women suffering from hypothyroidism, more detailed studies are needed to prove the effectiveness of this intervention, as an adjuvant treatment to the standard pharmacotherapy. [ABSTRACT FROM AUTHOR]

Background: Antisocial behavior during adolescence can have long-lasting negative effects and leads to high societal costs. Forensic Outpatient Systemic Therapy (Forensische Ambulante Systeem Therapie; FAST) is a promising treatment for juveniles aged 12–21 showing severe antisocial behavior. The intensity, content and duration of FAST can be adjusted to the needs of the juvenile and their caregiver(s), which is considered crucial for effective treatment. Next to the regular version of FAST (FASTr), a blended version (FASTb) in which face-to-face contacts are replaced by minimally 50% online contacts over the duration of intervention was developed during the Covid-19 pandemic. The current study will investigate whether FASTb is equally effective as FASTr, and through which mechanisms of change, for whom, and under which conditions FASTr and FASTb work. Methods: A randomized controlled trial (RCT) will be carried out. Participants (N = 200) will be randomly assigned to FASTb (n = 100) or FASTr (n = 100). Data collection will consist of self-report questionnaires and case file analysis, and include a pre-test at the start of the intervention, a post-test immediately after the intervention, and a six month follow-up. Mechanisms of change will be investigated using monthly questionnaires of key variables during treatment. Official recidivism data will be collected at two-year follow-up. Discussion: This study aims to improve the effectiveness and quality of forensic mental health care for juveniles with antisocial behavior by studying the effectiveness of blended care, which has not been studied before in treatment of externalizing behavior. If found to be at least as effective as face-to-face treatment, blended treatment can help meet the urgent need for more flexible and efficient interventions in this field. In addition, the proposed study aims to unravel what works for whom, knowledge urgently needed in mental health care for juveniles with severe antisocial behavior. Trial registration: This trial was registered at ClinicalTrials.gov on 07/11/2022, registration number NCT05606978. [ABSTRACT FROM AUTHOR]

Background: Major Depressive Disorder (MDD) is a leading cause of disability worldwide. Approximately one-third of patients with MDD do not respond to treatment, and often exhibit elevated inflammation biomarkers, which are associated with worse prognosis. Previous research has linked healthier dietary patterns, such as the Mediterranean Diet (MedDiet), with a lower risk of MDD and symptoms of depression, potentially due to their anti-inflammatory properties. The aim of this study is to evaluate the effectiveness of a nutritional counselling intervention promoting MedDiet to alleviate symptoms of depression in adults recently diagnosed with MDD and presenting with elevated inflammation biomarkers. Methods: This study is a randomized controlled trial (RCT) that will recruit adults from outpatient clinics, between the ages of 18 and 70 years who have been diagnosed with MDD and are currently receiving treatment with the first prescribed antidepressant, and who exhibit elevated inflammation biomarkers (interleukin-6 and/or C-reactive protein). The control group will receive treatment-as-usual (TAU) only. The primary outcome of the study will be the change in symptoms of depression, as measured by the Beck Depression Inventory 2 (BDI-II), after 12 weeks of intervention. Data analysis will follow an intention-to-treat approach. Secondary outcomes will include changes in inflammation biomarkers, quality of life, adherence to the MedDiet, and cost-effectiveness of nutritional counselling. All outcomes will be assessed at baseline, after the 12-week intervention, and at 6- and 12-months post-baseline. Discussion: This study will be the first RCT to evaluate the effect of a nutritional intervention with anti-inflammatory properties, as an adjuvant in the treatment of MDD, in individuals diagnosed with MDD and elevated inflammation biomarkers. The results of this study may contribute to the development of more effective and personalized interventions for MDD patients with elevated inflammation biomarkers. [ABSTRACT FROM AUTHOR]

Background: Randomized Controlled Trial is the most rigorous study design to test the efficacy and effectiveness of an intervention. Patient preference may negatively affect patient performance and decrease the generalizability of a trial to clinical population. Patient preference trial have particular implications in the field of mental health and addiction since mental health interventions are generally complex, blinding of intervention is often difficult or impossible, patients may have strong preference, and outcome measures are often subjective patient self-report which may be greatly influenced if patient's preference did not match with the intervention received. Methods: In this review, we have surveyed the application of two-stage randomized preference trial with focus on studies in the field of mental health and addiction. The study selection followed the guideline provided by Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Results: Six two-stage randomized preference trials (ten publications) have been identified in the field of mental health field and addiction. In these trials, the pooled dropout rates were 18.3% for the preference arm, and 28.7% for the random arm, with a pooled RR of 0.70 (95% CI, 0.56–0.88; P = 0.010) indicating lower risk of dropout in the preference arm. The standardized preference effects varied widely from 0.07 to 0.57, and could be as large as the treatment effect in some of the trials. Conclusion: This scoping review has shown that two-stage randomized preference trials are not as popular as expected in mental health research. The results indicated that two-stage randomized preference trials in mental health would be beneficial in retaining patients to expand the generalizability of the trial. [ABSTRACT FROM AUTHOR]

Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness. Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90 min each) prior to exposure therapy (consisting of eight weekly sessions of 90 min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment. Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach. Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is the most prevalent mental health disorder worldwide, including among U.S. service members. In addition to evidence-based treatments, activity-based approaches have been shown to effectively treat depressive symptoms, particularly when they occur in the natural environment. Methods: This study compared two activity-based interventions, Surf Therapy and Hike Therapy, on depression outcomes among 96 active duty service members with MDD. Participants were randomized to 6 weeks of Surf or Hike Therapy. Clinician-administered and self-report measures were completed at preprogram, postprogram, and 3-month follow-up. A brief depression/anxiety measure was completed before and after each activity session. Results: Multilevel modeling results showed that continuous depression outcomes changed significantly over time (ps <.001). Although service members in Hike Therapy reported higher average depression scores than those in Surf Therapy, the trajectory of symptom improvement did not significantly differ between groups. Regarding MDD diagnostic status, there were no significant differences between the groups at postprogram (p =.401), but Surf Therapy participants were more likely to remit from MDD than were those in Hike Therapy at the 3-month follow-up (p =.015). Limitations: The sample consisted of service members, so results may not generalize to other populations. Most participants received concurrent psychotherapy or pharmacotherapy, and, although statistically accounted for, results should be interpreted in this context. Conclusions: Both Surf and Hike Therapies appear to be effective adjunctive interventions for service members with MDD. Research is needed to examine the effectiveness of these therapies as standalone interventions. Trial registration: Clinical trials registration number NCT03302611; First registered on 05/10/2017. [ABSTRACT FROM AUTHOR]

Background: Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and effectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Methods: A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verified by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical fitness, cardiovascular risks, substance use, quality of life, and health-related self-efficacy at 12 months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals. Discussion: The results of the KISMET trial will contribute to the evidence gap of effective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system. Trial registration: Netherlands Trial Register, NTR9783. Registered on 18 October 2021. [ABSTRACT FROM AUTHOR]

Background: Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders. Methods /design: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ). Discussion: We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression. Trial registration: Netherlands Trial Register (NL8955). Registered on October 6th2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955 [ABSTRACT FROM AUTHOR]

Background: Psychosocial interventions for adolescents with attention-deficit/hyperactivity disorder (ADHD), targeting emotional dysregulation and impulsive behaviors, have been requested, but the heterogeneity within this group makes it unlikely that there is one treatment that fits all. The aim of this study was to identify which adolescents with ADHD might have an effect from a structured skills training group (SSTG) based on dialectical behavioral therapy, by exploring pre-treatment characteristics as potential moderators of long-term treatment outcome. Methods: This study was based on follow-up data from a randomized controlled trial comparing the SSTG (n = 71) to a psychoeducational control intervention (n = 57) for adolescents with ADHD (15–18 years old). Clinical characteristics (sex, age, medication status, ADHD presentation, severity of ADHD symptom, psychiatric comorbidity, impairment of emotional dysregulation and functional impairment) were explored as potential moderators of pre-treatment to follow-up change in ADHD symptoms and functional impairment. Moderation analyses were performed using the PROCESS macro for SPSS. Results: Three moderators (severity of hyperactivity/impulsivity, conduct problems and impairment of emotional dysregulation) were identified in regard to the outcome self-rated change in ADHD symptoms. Participants with elevated pre-scores on these variables had a better effect of the SSTG than of the psychoeducational control intervention. No moderators were found in regard to the parental-rated outcomes. Conclusions: The SSTG seems to be beneficial for adolescents with ADHD who perceive pronounced symptoms of hyperactivity/impulsivity, conduct problems and emotional dysregulation. Our findings need to be confirmed in future trials evaluating dialectical behavioral therapy-based skills training for adolescents with ADHD, where these moderators could be used as criteria for inclusion or stratification. Trial registration: https://doi.org/10.1186/ISRCTN17366720, retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Depression is a leading cause of disability in adolescents, however few receive evidence-based treatment. Despite having the potential to overcome barriers to treatment uptake and adherence, there are very few CBT-based smartphone apps for adolescents. To address this gap, we developed ClearlyMe®, a self-guided CBT smartphone app for adolescent depression and anxiety. ClearlyMe® consists of 37 brief lessons containing core CBT elements, accessed either individually or as part of a 'collection'. Here, we describe the protocol for a randomised controlled trial aiming to evaluate the effect of ClearlyMe® on depressive symptoms and secondary outcomes, including engagement, anxiety and wellbeing, when delivered with and without guided support compared to an attention matched control. Methods: We aim to recruit 489 adolescents aged 12-17 years with mild to moderately-severe depressive symptoms. Participants will be screened for inclusion, complete the baseline assessment and are then randomly allocated to receive ClearlyMe® (self-directed use), ClearlyMe® with guided SMS support (guided use) or digital psychoeducation (attention-matched control). Depressive symptoms and secondary outcomes will be assessed at 6-weeks (primary endpoint) and 4-months post-baseline (secondary endpoint). Engagement, conceptualised as uptake, adherence and completion, will also be assessed 6-weeks post-baseline. Mixed-effects linear modelling will be used to conduct intention-to-treat analyses to determine whether reductions in depressive symptoms and secondary outcomes are greater for conditions receiving ClearlyMe® relative to control at 6-weeks and 4-months post-baseline and greater for intervention adherers relative to non-adherers. To minimise risk, participants will be encouraged to use the Get Help section of the app and can also opt to receive a call from the team clinical psychologist at baseline, and at the 6-week and 4-month post-baseline assessments when reporting suicidal ideation. Discussion: This is the first clinical trial examining a CBT smartphone app specifically designed for adolescent depression. It will provide empirical evidence on the effects of ClearlyMe® on depressive symptoms when used with and without guided support. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12622000131752). Universal trial number: U1111-1271-8519. [ABSTRACT FROM AUTHOR]

Background: Obsessive-Compulsive Disorder (OCD) is characterized by disturbing and unwanted thoughts as well as repetitive and time-consuming behaviors that interfere with performance. Cognitive Behavior Therapy (CBT) has shown to have beneficial effects on reducing OCD symptoms as the first line of treatment. Moreover, Virtual Reality (VR) has been a more feasible and accessible intervention for OCD in recent years. Regarding the point, the objective of this study was to evaluate the effectiveness of virtual reality exposure and response prevention (VRERP) in the treatment of the OCD contamination subtype. Methods: A total number of 36 adults with OCD-contamination subtype were registered and randomly assigned to the intervention and control groups. The intervention group received a 60-min CBT including a "contaminated" virtual environment while the control group received CBT as a standardized treatment. Out of these, 29 patients completed the treatment in 12 weekly sessions. The patients completed the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Obsessive Beliefs Questionnaire-44(OBQ-44), and World Health Organization Disability Assessment Scale-2 (WHODAS-2) at week 0, week 12 and after 3 months follow-up. Results: Based on the results of the repeated measure analysis of variances, the total score of obsession and compulsion subscales of Y-BOCS significantly decreased as a primary outcome in the intervention group (F = 60.97, P < 0.001, partial eta squared = 0.82; F = 20.46, P < 0.001, partial eta squared = 0.61; F = 29.57, P < 0.001, partial eta squared = 0.69; respectively). The total score of BDI-II and BAI was reduced in both groups but there was no significant difference between them (BDI-II: F = 0.54, P = 0.47, partial eta squared = 0.02; BAI: F = 3.12, P = 0.06, partial eta squared = 0.19). However, there was a significant difference in the OBQ-44 (F = 16.78, P < 0.001, partial eta squared = 0.56) and the total WHODAS-2 score between the groups (F = 14.64, P < 0.001, partial eta squared = 0.53). Conclusions: This study demonstrated the effectiveness of VRERP in the treatment of the OCD-contamination subtype. Therefore, VRERP can be used in CBT as an alternative exposure tool. Trial registration: Iranian Registry of Clinical Trials, IRCT ID: IRCT20210214050353N1, Registered on 16/10/2021. [ABSTRACT FROM AUTHOR]