Search

Abstract Background People with severe mental illness (SMI) face not only impaired mental health, but also a greater risk of physical comorbidities and a shorter life expectancy compared to the general population. A poor lifestyle plays a substantial role in this disparity. Combined Lifestyle Interventions targeting multiple lifestyle behaviors can improve mental and physical health, and quality of life. However, there is currently no appropriate structural support for people with SMI in outpatient care in the Netherlands. The Combined Lifestyle Intervention for Outpatients with SMI (GOAL!) is developed to address this gap. This study examines the (cost-)effectiveness and implementation of GOAL!. Methods In a type 1 hybrid quasi-experimental study with a mixed-method matched design, GOAL! participants (N = 50) are compared to people receiving care as usual (N = 50). The GOAL! program includes group and individual sessions, given by allied health professionals, over a period of two years. The first year starts with a 3-month intensive course on physical activity and nutrition, followed by 9 months of aftercare covering various lifestyle topics tailored to the group’s needs. There is close collaboration with local stakeholders to facilitate transfer to the community setting. The second year focuses on maintaining established activities in one’s daily living environment. Our primary outcome will be the change in physical activity, comparing GOAL! participants to those receiving care as usual. Secondary outcomes are changes in other lifestyle behaviors, physical health, mental well-being, and healthcare and societal costs. Additionally, achieving lifestyle-related goals, adverse effects, and barriers and facilitators to implementation are examined. Measurements are obtained at start (T0), and after 3 (T1), 12 (T2) and 24 months (T3). Discussion This study investigates the effects of GOAL! on lifestyle behaviors, health outcomes, implementation factors and cost-effectiveness after two years, aiming to offer valuable insights into the effectiveness and implementation outcomes of lifestyle interventions for outpatients with SMI. Trial registration : ClinicalTrials.gov (Identifier: NCT05600205). Prospectively registered on October 26, 2022.

Background: In Ghana, the use of illegal drugs and alcohol has been classified as endemic. To manage this menace, the Therapeutic Community model for Substance Use Disorders (SUD) was introduced in Ghana about a decade ago as an alternative to other existing strategies. However, the effectiveness of this treatment modality for substance use disorders in Pantang Mental Hospital and Accra Psychiatric Hospital has not been scientifically studied. Objective: This study, therefore, sought to explore the experiences of substance users or residents enrolled in the Therapeutic Community programme toward recovery from substance use disorders. Method: This research employed an explorative-descriptive design. Participants (N = 20) were enrolled purposively sampled and recruited into the study. Face-to-face interviews were conducted using a semi-structured guide and data were analyzed using Colaizzi's descriptive phenomenology data analysis process. Results: Two main themes emerged from the data: "Why I stayed" (Motivation), and "All things are new" (Life transformation). The study pointed out that residents or participants mainly expressed positive experiences in the programme, including experiencing a sense of belongingness, enhanced self-esteem/self-worth, and most importantly, developing hope of a life free of addiction. Conclusion: In conclusion, the study found that participants in the Therapeutic Community (TC) program generally had positive experiences and believed in its effectiveness for recovery. Factors such as a relaxed environment, supportive staff, and interactions with other residents contributed to their positive experience. The study discovered that motivation, a conducive environment for care, structured program activities, and relationships among residents were key factors that motivated participants to stay and actively participate in the therapeutic community program. These factors fostered hope and a sense of belonging, ultimately contributing to their recovery journey. However, participants expressed the need for self-actualization, which they hoped to achieve after completing the program and reintegrating into the community. [ABSTRACT FROM AUTHOR]

Abstract Background Severe mental illness (SMI) imposes a substantial worldwide burden of disability, highlighting the need for comprehensive and adaptable mental health services. This study aims to assess the efficacy and cost-effectiveness of community-based mental health services (CBMHS) in reducing relapse and rehospitalization rates among individuals with SMI in Iran. Method A systematic review and meta-analysis were conducted. Medline, EMBASE, ISI, SCOPUS, and ProQuest were searched until December 2022. We focused on randomized controlled trials, quasi-experimental studies, or economic studies related to individuals with SMI. Out of 127 articles, 17 were selected for a full-text review. The primary outcomes were the severity of psychopathology, rehospitalization rates, and the mental health of caregivers. We also examined community-based interventions and their impact on various outcomes. Data extraction and risk of bias assessment were performed, and critical appraisal was conducted using JBI checklists. Meta-analysis was carried out using STATA software. (PROSPERO registration. CRD42022332660). Result Rehospitalization rates among patients who received CBMHS were significantly lower, with an odds ratio of 2.14 (95% CI: 1.44 to 3.19), indicating a 2.14 times lower likelihood than those who received treatment as usual. A reduction in psychopathology accompanied this, SMD: -0.31, 95% CI: -0.49 to -0.13, I2 = 40.23%). Moreover, there was a notable improvement in social skills (SMD: -0.7, 95% CI: -0.98 to -0.44, I2 = 0.00%). The burden on caregivers also decreased (SMD: -0.55, 95% CI: -0.99 to -0.1, I2 = 63.2). The Incremental Cost-Effectiveness Ratio (ICER) for QUALY was acceptable, albeit with a wide range of 613 to 8400 Dollars. Conclusion CBMHS has demonstrated effectiveness and efficiency in Iran as a developing country. Additionally, it shows promise in mitigating the shortage of acute psychiatry beds. Using multiple data collection tools poses a limitation regarding data consolidation and conducting a meta-analysis.

Background: Severe mental illness (SMI) imposes a substantial worldwide burden of disability, highlighting the need for comprehensive and adaptable mental health services. This study aims to assess the efficacy and cost-effectiveness of community-based mental health services (CBMHS) in reducing relapse and rehospitalization rates among individuals with SMI in Iran. Method: A systematic review and meta-analysis were conducted. Medline, EMBASE, ISI, SCOPUS, and ProQuest were searched until December 2022. We focused on randomized controlled trials, quasi-experimental studies, or economic studies related to individuals with SMI. Out of 127 articles, 17 were selected for a full-text review. The primary outcomes were the severity of psychopathology, rehospitalization rates, and the mental health of caregivers. We also examined community-based interventions and their impact on various outcomes. Data extraction and risk of bias assessment were performed, and critical appraisal was conducted using JBI checklists. Meta-analysis was carried out using STATA software. (PROSPERO registration. CRD42022332660). Result: Rehospitalization rates among patients who received CBMHS were significantly lower, with an odds ratio of 2.14 (95% CI: 1.44 to 3.19), indicating a 2.14 times lower likelihood than those who received treatment as usual. A reduction in psychopathology accompanied this, SMD: -0.31, 95% CI: -0.49 to -0.13, I2 = 40.23%). Moreover, there was a notable improvement in social skills (SMD: -0.7, 95% CI: -0.98 to -0.44, I2 = 0.00%). The burden on caregivers also decreased (SMD: -0.55, 95% CI: -0.99 to -0.1, I2 = 63.2). The Incremental Cost-Effectiveness Ratio (ICER) for QUALY was acceptable, albeit with a wide range of 613 to 8400 Dollars. Conclusion: CBMHS has demonstrated effectiveness and efficiency in Iran as a developing country. Additionally, it shows promise in mitigating the shortage of acute psychiatry beds. Using multiple data collection tools poses a limitation regarding data consolidation and conducting a meta-analysis. [ABSTRACT FROM AUTHOR]

Abstract Background Recovery Colleges (RCs) have spread across the globe as a new way of supporting people with mental vulnerabilities in their recovery journey. RCs focus on ‘learning’ rather than ‘curing’ and in that line facilitate a transition from being a passive, dependent patient/client to an active, empowered student learning to live life, despite vulnerabilities. Peer support and co-creation are central in RCs, as peers learn from each other by sharing personal experiences with mental vulnerabilities in an accessible, inspiring and stimulating atmosphere. The implementation of RCs is highly encouraged internationally, and as a result RCs and related self-help initiatives increasingly emerge. However, high-quality research on RCs is scarce and there is a call for thorough investigation of (cost-)effectiveness, mechanisms of action, cross-border fidelity and positioning of RCs. In response, this research project aims to fill these gaps. Methods This research project entails (1) a prospective quasi-experimental effectiveness study and economic evaluation, (2) a multifaceted qualitative study to elaborate on the mechanisms of action of RCs for those involved (3) a study to develop a (Dutch) Fidelity Measure of Recovery Colleges, and (4) an organisational case study to describe the positioning of RCs in relation to other mental health care services and community-based initiatives. Following the ideals of co-creation and empowerment in RCs we conduct this research project in co-creation with RC students from Enik Recovery College in Utrecht, the Netherlands. Discussion This research project will lead to one of the first longitudinal controlled quantitative evaluations of both cost-effectiveness and effectiveness of RC attendance in a broad sense (beyond attending courses alone). Moreover, we will gather data on a micro level (i.e., impact on RC students), meso level (i.e., organisational fidelity) and macro level (i.e., positioning in the care and support domain), capturing all important perspectives when scrutinizing the impact of complex systems. Finally, we will demonstrate the validity and value of embracing experiential knowledge in science as a complementary source of information, leading to a more profound understanding of what is researched. Trial registration The prospective quasi-experimental study has been pre-registered at clinicaltrails.gov (#NCT05620212).

Abstract Background Antipsychotic treatment may improve clinical insight. However, previous studies have reported inconclusive findings on whether antipsychotics improve insight over and above the reduction in symptoms of psychosis. These studies assessed homogeneous samples in terms of stage of illness. Randomised studies investigating a mixed population of first- and multiepisode schizophrenia spectrum disorders might clarify this disagreement. Methods Our data were derived from a pragmatic, rater-blinded, semi-randomised trial that compared the effectiveness of amisulpride, aripiprazole and olanzapine. A sample of 144 patients with first- or multiepisode schizophrenia spectrum disorders underwent eight assessments during a 1-year follow-up. Clinical insight was assessed by item General 12 from the Positive and Negative Syndrome Scale (PANSS). We analysed latent growth curve models to test if the medications had a direct effect on insight that was over and above the reduction in total psychosis symptoms. Furthermore, we investigated whether there were differences between the study drugs in terms of insight. Results Based on allocation analysis, all three drugs were associated with a reduction in total psychosis symptoms in the initial phase (weeks 0–6). Amisulpride and olanzapine were associated with improved insight over and above what was related to the reduction in total psychosis symptoms in the long-term phase (weeks 6–52). However, these differential effects were lost when only including the participants that chose the first drug in the randomisation sequence. We found no differential effect on insight among those who were antipsychotic-naïve and those who were previously medicated with antipsychotics. Conclusions Our results suggest that antipsychotic treatment improves insight, but whether the effect on insight surpasses the effect of reduced total psychosis symptoms is more uncertain. Trial registration ClinicalTrials.gov Identifier: NCT01446328, 05.10.2011.

Abstract 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 Background A post-marketing surveillance of blonanserin has been ongoing since September 2018. The aim of this study was to assess the effectiveness and safety of oral blonanserin in Chinese young and middle-aged female patients with schizophrenia in real clinical settings, using the data from the post-marketing surveillance. Methods A 12-week, prospective, multi-center, open-label, post-marketing surveillance was conducted. Female patients aged 18–40 years were included in this analysis. The Brief Psychiatric Rating Scale (BPRS) was used to evaluate the effectiveness of blonanserin in improving psychiatric symptoms. The incidence of adverse drug reactions (ADRs) such as of extrapyramidal symptoms (EPS), prolactin elevation and the weight gain were used to evaluate the safety profile of blonanserin. Results A total of 392 patients were included both in the safety and full analysis sets, 311 patients completed the surveillance protocol. The BPRS total score was 48.8 ± 14.11 at the baseline, decreasing to 25.5 ± 7.56 at 12 weeks (P

Abstract Background Although the prevalence of psychological problems in transitional-age youth (i.e., youth aged 15 to 25; TAY) is high, TAY are much less likely to receive age-appropriate treatments for their psychological problems compared to younger adolescents or older adults. Hence, effective interventions for TAY seem warranted. ACT your way is a transdiagnostic treatment, specifically developed for TAY, based on the principles of Acceptance and Commitment Therapy (ACT). ACT your way is not directed primarily at symptom reduction, but mainly aims to change the underlying mechanism of psychopathology, namely increasing TAY’s psychological flexibility. Meta-analyses show that ACT is an effective treatment for adults with diverse types of psychopathology. Less is known about the effectiveness of ACT for TAY. Therefore, the goal of this study is to examine the effectiveness and cost-effectiveness of ACT your way. In addition, we will investigate for whom and under what circumstances (i.e., moderators) and how (i.e., mediators) the intervention is (most) effective. Method The study is designed as a multi-centre, randomized controlled trial. In total, 140 TAY diagnosed with any psychological disorder will be randomly assigned to either the ACT your way or treatment as usual (TAU) condition. In total, six assessments will be conducted: at baseline, after 3, 6 and 9 sessions, at post-intervention and at 6-month follow-up, using multiple informants (TAY, parents/caregivers, therapists). Assessments will include diagnostic interviews and questionnaires. The primary outcomes are psychological flexibility and number of DSM-5 diagnoses; the secondary outcomes are the presence of the primary DSM-5 diagnosis, psychopathology, personality problems, global, individual and societal functioning, quality of life, stress, treatment satisfaction, treatment drop-out and therapeutic alliance. We will also assess costs and various moderators (i.e., demographic characteristics, type and severity of problems, psychopathology of parents/caregivers, treatment expectancy and previous treatments) and mediators (i.e., psychological flexibility, emotion regulation, self-compassion, autonomy, perfectionism, self-esteem and group cohesion). Discussion To our knowledge, this is the first study investigating the (cost-)effectiveness of ACT compared to TAU in clinically referred TAY with various types of psychopathology, using a rigorous design. Trial registration The research project is registered in the Dutch Trial Register (Trial NL9642).

Background: Antipsychotic treatment may improve clinical insight. However, previous studies have reported inconclusive findings on whether antipsychotics improve insight over and above the reduction in symptoms of psychosis. These studies assessed homogeneous samples in terms of stage of illness. Randomised studies investigating a mixed population of first- and multiepisode schizophrenia spectrum disorders might clarify this disagreement. Methods: Our data were derived from a pragmatic, rater-blinded, semi-randomised trial that compared the effectiveness of amisulpride, aripiprazole and olanzapine. A sample of 144 patients with first- or multiepisode schizophrenia spectrum disorders underwent eight assessments during a 1-year follow-up. Clinical insight was assessed by item General 12 from the Positive and Negative Syndrome Scale (PANSS). We analysed latent growth curve models to test if the medications had a direct effect on insight that was over and above the reduction in total psychosis symptoms. Furthermore, we investigated whether there were differences between the study drugs in terms of insight. Results: Based on allocation analysis, all three drugs were associated with a reduction in total psychosis symptoms in the initial phase (weeks 0–6). Amisulpride and olanzapine were associated with improved insight over and above what was related to the reduction in total psychosis symptoms in the long-term phase (weeks 6–52). However, these differential effects were lost when only including the participants that chose the first drug in the randomisation sequence. We found no differential effect on insight among those who were antipsychotic-naïve and those who were previously medicated with antipsychotics. Conclusions: Our results suggest that antipsychotic treatment improves insight, but whether the effect on insight surpasses the effect of reduced total psychosis symptoms is more uncertain. Trial registration: ClinicalTrials.gov Identifier: NCT01446328, 05.10.2011. [ABSTRACT FROM AUTHOR]

Abstract Background Recovery Colleges are a relatively recent initiative within mental health services. The first opened in 2009 in London and since then numbers have grown. They are based on principles of personal recovery in mental health, co-production between people with lived experience of mental health problems and professionals, and adult learning. Student eligibility criteria vary, but all serve people who use mental health services, with empirical evidence of benefit. Previously we developed a Recovery College fidelity measure and a preliminary change model identifying the mechanisms of action and outcomes for this group, which we refer to as service user students. The Recovery Colleges Characterisation and Testing (RECOLLECT) study is a five-year (2020–2025) programme of research in England. The aim of RECOLLECT is to determine Recovery Colleges’ effectiveness and cost-effectiveness, and identify organisational influences on fidelity and improvements in mental health outcomes. Methods RECOLLECT comprises i) a national survey of Recovery Colleges, ii) a prospective cohort study to establish the relationship between fidelity, mechanisms of action and psychosocial outcomes, iii) a prospective cohort study to investigate effectiveness and cost-effectiveness, iv) a retrospective cohort study to determine the relationship between Recovery College use and outcomes and mental health service use, and v) organisational case studies to establish the contextual and organisational factors influencing fidelity and outcomes. The programme has been developed with input from individuals who have lived experience of mental health problems. A Lived Experience Advisory Panel will provide input into all stages of the research. Discussion RECOLLECT will provide the first rigorous evidence on the effectiveness and cost effectiveness of Recovery Colleges in England, to inform their prioritising, commissioning, and running. The validated RECOLLECT multilevel change model will confirm the active components of Recovery Colleges. The fidelity measure and evidence about the fidelity-outcome relationship will provide an empirically-based approach to develop Recovery Colleges, to maximise benefits for students. Findings will be disseminated through the study website (researchintorecovery.com/recollect) and via national and international Recovery College networks to maximise impact, and will shape policy on how Recovery Colleges can help those with mental health problems lead empowered, meaningful and fulfilling lives.

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]

Abstract Background Crisis Resolution Home Treatment (CRHT) is an alternative to inpatient treatment for acute psychiatric crises management. However, evidence on CRHT effectiveness is still limited. In the Canton of Ticino (Southern Switzerland), in 2016 the regional public psychiatric hospital replaced one acute ward with a CRHT. The current study was designed within this evaluation setting to assess the effectiveness of CRHT compared to standard inpatient treatment. Methods CRHT was offered to patients aged 18 to 65 with an acute psychiatric crisis that would have required hospitalization. We used a natural experiment based on geography, where intervention and control groups were formed according to the place of residence. Primary endpoints were reduction of psychiatric symptoms at discharge measured using the Health of the Nation Outcome Scales, treatment duration in days, and rate and length of readmissions during a two-year follow-up period after discharge. Safety during the treatment period was measured with the number of serious adverse events (suicide/suicide attempts, major self-harm episodes, acute alcohol/drug intoxications, aggressions to caregivers or family members). We used linear, log-linear and logistic regression models with propensity scores for the main analysis. Results We enrolled 321 patients; 67 were excluded because the treatment period was too short and 17 because they were transferred before the end of the treatment. Two hundred thirty-seven patients were available for data analysis, 93 in the intervention group and 144 in the control group. No serious adverse event was observed during the treatment period in both groups. Reduction of psychiatric symptoms at discharge (p-value = 0.359), readmission rates (p-value = 0.563) and length of readmissions (p-value = 0.770) during the two-year follow-up period did not differ significantly between the two groups. Treatment duration was significantly higher in the treatment group (+ 29.6% on average, p-value = 0.002). Conclusions CRHT was comparable to standard hospitalization in terms of psychiatric symptoms reduction, readmission rates and length of readmissions, but it was also characterized by a longer first treatment period. However, observational evidence following the study indicated that CRHT duration constantly lowered over time since its introduction in 2016 and became comparable to hospitalization, showing therefore to be an effective alternative also in terms of treatment length. Trial registration ISRCTN38472626 (17/11/2020, retrospectively registered).

Abstract Background People with mental illness have a reduced life expectancy compared to the general population. Despite the increasing evidence for the efficacy of lifestyle interventions there is little change in routine clinical care. This discrepancy is often referred to as the implementation gap and has caused a need for effectiveness and implementation research in real-world settings. Our study assesses the effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +). Methods An open cohort stepped wedge cluster randomized trial in inpatients psychiatric wards of GGz Centraal, the Netherlands. The wards are divided into three clusters based on geographical region. These clusters are randomly allocated to one of the three pre-defined steps to integrate MULTI + . MULTI + can be tailored to fit individual psychiatric wards and includes 10 core components aimed at improving lifestyle factors. The primary outcome is to investigate the difference in the mean QRISK3 score of patients receiving MULTI + compared to patients receiving TAU. Secondary outcomes include somatic and mental health outcomes, lifestyle factors, and implementation factors. Findings will be analysed using mixed model analyses. Discussion The MULTI + study is the first large-scale study evaluating the long-term effects of a multidisciplinary, multicomponent approach aimed at improving lifestyle factors in routine inpatient mental health care. A limitation of this study is the risk of missing data due to the large-scale, real-world setting of this study. Furthermore, implementation monitoring and external events that may influence outcomes could be difficult to account for. Strengths of this study are the focus on effectiveness as well as implementation and the inclusion of both patient and health care professionals’ perspectives. Effectiveness studies in routine clinical care can advance our knowledge on lifestyle interventions in real-world settings. Trial registration ClinicalTrials.gov registration. Identifier: NCT04922749 . Retrospectively registered 3th of June 2021.

Background: A post-marketing surveillance of blonanserin has been ongoing since September 2018. The aim of this study was to assess the effectiveness and safety of oral blonanserin in Chinese young and middle-aged female patients with schizophrenia in real clinical settings, using the data from the post-marketing surveillance. Methods: A 12-week, prospective, multi-center, open-label, post-marketing surveillance was conducted. Female patients aged 18–40 years were included in this analysis. The Brief Psychiatric Rating Scale (BPRS) was used to evaluate the effectiveness of blonanserin in improving psychiatric symptoms. The incidence of adverse drug reactions (ADRs) such as of extrapyramidal symptoms (EPS), prolactin elevation and the weight gain were used to evaluate the safety profile of blonanserin. Results: A total of 392 patients were included both in the safety and full analysis sets, 311 patients completed the surveillance protocol. The BPRS total score was 48.8 ± 14.11 at the baseline, decreasing to 25.5 ± 7.56 at 12 weeks (P < 0.001, compared with baseline). EPS (20.2%) including akathisia, tremor, dystonia, and parkinsonism were found as the most frequent ADRs. The mean weight gain was 0.27 ± 2.5 kg at 12 weeks from the baseline. Four cases (1%) of prolactin elevation were observed during the period of surveillance. Conclusion: Blonanserin significantly improved the symptoms of schizophrenia in female patients aged 18–40 years; the drug was well tolerated and had a low tendency to cause metabolic side effects, including prolactin elevation in these patients. Blonanserin might be a reasonable drug for the treatment of schizophrenia in young and middle-aged female patients. [ABSTRACT FROM AUTHOR]

Background: Although the prevalence of psychological problems in transitional-age youth (i.e., youth aged 15 to 25; TAY) is high, TAY are much less likely to receive age-appropriate treatments for their psychological problems compared to younger adolescents or older adults. Hence, effective interventions for TAY seem warranted. ACT your way is a transdiagnostic treatment, specifically developed for TAY, based on the principles of Acceptance and Commitment Therapy (ACT). ACT your way is not directed primarily at symptom reduction, but mainly aims to change the underlying mechanism of psychopathology, namely increasing TAY's psychological flexibility. Meta-analyses show that ACT is an effective treatment for adults with diverse types of psychopathology. Less is known about the effectiveness of ACT for TAY. Therefore, the goal of this study is to examine the effectiveness and cost-effectiveness of ACT your way. In addition, we will investigate for whom and under what circumstances (i.e., moderators) and how (i.e., mediators) the intervention is (most) effective. Method: The study is designed as a multi-centre, randomized controlled trial. In total, 140 TAY diagnosed with any psychological disorder will be randomly assigned to either the ACT your way or treatment as usual (TAU) condition. In total, six assessments will be conducted: at baseline, after 3, 6 and 9 sessions, at post-intervention and at 6-month follow-up, using multiple informants (TAY, parents/caregivers, therapists). Assessments will include diagnostic interviews and questionnaires. The primary outcomes are psychological flexibility and number of DSM-5 diagnoses; the secondary outcomes are the presence of the primary DSM-5 diagnosis, psychopathology, personality problems, global, individual and societal functioning, quality of life, stress, treatment satisfaction, treatment drop-out and therapeutic alliance. We will also assess costs and various moderators (i.e., demographic characteristics, type and severity of problems, psychopathology of parents/caregivers, treatment expectancy and previous treatments) and mediators (i.e., psychological flexibility, emotion regulation, self-compassion, autonomy, perfectionism, self-esteem and group cohesion). Discussion: To our knowledge, this is the first study investigating the (cost-)effectiveness of ACT compared to TAU in clinically referred TAY with various types of psychopathology, using a rigorous design. Trial registration: The research project is registered in the Dutch Trial Register (Trial NL9642). [ABSTRACT FROM AUTHOR]

Abstract Background Approximately one in ten men experience mental health difficulties during the early years of fatherhood, and these can have negative impacts on children and families. However, few evidence-based interventions targeting fathers’ mental health are available. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of Working Out Dads (WOD) – a facilitated peer support group intervention for fathers of young children, in reducing psychological distress and other mental health symptoms. Methods This trial will employ a parallel-arm randomised controlled trial (RCT) to evaluate the effectiveness and cost effectiveness of WOD peer support group intervention compared to usual care (a 30-min mental health and service focused phone consultation with a health professional). A total of 280 fathers of young children (aged 0-4 years) who are experiencing mental health difficulties and/or are at risk of poor mental health will be recruited. Randomisation and analyses will be at the level of the individual participant. The primary outcome is psychological distress symptoms, measured by the Kessler Psychological Distress Scale (K10) from baseline to 24 weeks post randomisation. A range of secondary outcomes will be assessed including suicidal ideation; mental health disorders, specific symptoms of depression, anxiety, and stress; social support, quality of life, health service use, and health care costs. Data will be collected at baseline, 10- and 24 weeks post-randomisation. Discussion This trial will examine the effectiveness of a novel group-based peer support intervention in reducing the psychological distress and other mental health symptoms of fathers compared to usual care. The economic and process evaluation will guide policy decision making along with informing the future implementation of WOD on a larger scale if effectiveness is demonstrated. Trial registration The current trial has been registered with ClinicalTrials.gov (Registration ID - NCT04813042 ). Date of Registration: March 22nd, 2021.

Background: Recovery Colleges are a relatively recent initiative within mental health services. The first opened in 2009 in London and since then numbers have grown. They are based on principles of personal recovery in mental health, co-production between people with lived experience of mental health problems and professionals, and adult learning. Student eligibility criteria vary, but all serve people who use mental health services, with empirical evidence of benefit. Previously we developed a Recovery College fidelity measure and a preliminary change model identifying the mechanisms of action and outcomes for this group, which we refer to as service user students. The Recovery Colleges Characterisation and Testing (RECOLLECT) study is a five-year (2020–2025) programme of research in England. The aim of RECOLLECT is to determine Recovery Colleges' effectiveness and cost-effectiveness, and identify organisational influences on fidelity and improvements in mental health outcomes. Methods: RECOLLECT comprises i) a national survey of Recovery Colleges, ii) a prospective cohort study to establish the relationship between fidelity, mechanisms of action and psychosocial outcomes, iii) a prospective cohort study to investigate effectiveness and cost-effectiveness, iv) a retrospective cohort study to determine the relationship between Recovery College use and outcomes and mental health service use, and v) organisational case studies to establish the contextual and organisational factors influencing fidelity and outcomes. The programme has been developed with input from individuals who have lived experience of mental health problems. A Lived Experience Advisory Panel will provide input into all stages of the research. Discussion: RECOLLECT will provide the first rigorous evidence on the effectiveness and cost effectiveness of Recovery Colleges in England, to inform their prioritising, commissioning, and running. The validated RECOLLECT multilevel change model will confirm the active components of Recovery Colleges. The fidelity measure and evidence about the fidelity-outcome relationship will provide an empirically-based approach to develop Recovery Colleges, to maximise benefits for students. Findings will be disseminated through the study website (researchintorecovery.com/recollect) and via national and international Recovery College networks to maximise impact, and will shape policy on how Recovery Colleges can help those with mental health problems lead empowered, meaningful and fulfilling lives. [ABSTRACT FROM AUTHOR]

Abstract Background Traumatic stress is a global mental health problem requiring novel, easily implemented treatment solutions. We compared the effectiveness and efficiency of Reconsolidation Therapy (RT) to the well-established antidepressant paroxetine, in reducing symptoms of traumatic stress among patients from Nepal, a low-income country. Methods Forty-six adults with posttraumatic stress disorder (PTSD) were randomized to one of two groups. The reconsolidation blocker propranolol was administered 90 min before briefly recalling a traumatic memory with a therapist, weekly for six consecutive weeks. This was compared to daily paroxetine for 26 weeks. Self-reported PTSD symptoms were assessed blindly at the 7th, 13th, and 26th weeks. Results An intent-to-treat analysis revealed a robust pre- to post-treatment main effect (β 1 = − 4.83, 95% CI = [− 5.66, − 4.01], p

Background: Crisis Resolution Home Treatment (CRHT) is an alternative to inpatient treatment for acute psychiatric crises management. However, evidence on CRHT effectiveness is still limited. In the Canton of Ticino (Southern Switzerland), in 2016 the regional public psychiatric hospital replaced one acute ward with a CRHT. The current study was designed within this evaluation setting to assess the effectiveness of CRHT compared to standard inpatient treatment. Methods: CRHT was offered to patients aged 18 to 65 with an acute psychiatric crisis that would have required hospitalization. We used a natural experiment based on geography, where intervention and control groups were formed according to the place of residence. Primary endpoints were reduction of psychiatric symptoms at discharge measured using the Health of the Nation Outcome Scales, treatment duration in days, and rate and length of readmissions during a two-year follow-up period after discharge. Safety during the treatment period was measured with the number of serious adverse events (suicide/suicide attempts, major self-harm episodes, acute alcohol/drug intoxications, aggressions to caregivers or family members). We used linear, log-linear and logistic regression models with propensity scores for the main analysis. Results: We enrolled 321 patients; 67 were excluded because the treatment period was too short and 17 because they were transferred before the end of the treatment. Two hundred thirty-seven patients were available for data analysis, 93 in the intervention group and 144 in the control group. No serious adverse event was observed during the treatment period in both groups. Reduction of psychiatric symptoms at discharge (p-value = 0.359), readmission rates (p-value = 0.563) and length of readmissions (p-value = 0.770) during the two-year follow-up period did not differ significantly between the two groups. Treatment duration was significantly higher in the treatment group (+ 29.6% on average, p-value = 0.002). Conclusions: CRHT was comparable to standard hospitalization in terms of psychiatric symptoms reduction, readmission rates and length of readmissions, but it was also characterized by a longer first treatment period. However, observational evidence following the study indicated that CRHT duration constantly lowered over time since its introduction in 2016 and became comparable to hospitalization, showing therefore to be an effective alternative also in terms of treatment length. Trial registration: ISRCTN38472626 (17/11/2020, retrospectively registered). [ABSTRACT FROM AUTHOR]

Abstract Background Long-term community mental health treatment for non-psychotic disorder patients with severe mental illness (SMI) who are perceived as difficult by clinicians, is poorly developed and lacks a structured, goal-centred approach. This study compares (cost-)effectiveness of Interpersonal Community Psychiatric Treatment (ICPT) with Care As Usual (CAU) on quality of life and clinician perceived difficulty in the care for non-psychotic disorder SMI-patients. A multi-centre cluster-randomized clinical tria was conducted in which Community Mental Health Nurses (Clinicians) in three large community mental health services in the Netherlands were randomly allocated to providing either ICPT or CAU to included patients. A total of 56 clinicians were randomized, who treated a total of 93 patients (59 in ICPT-group and 34 in CAU-group). Methods Primary outcome measure is patient-perceived quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcome measures include clinician-perceived difficulty, general mental health, treatment outcomes, illness management and recovery, therapeutic relationship, care needs and social network. Patients were assessed at baseline, during treatment (6 months), after treatment (12 months) and at 6 months follow-up (18 months). Linear mixed-effects models for repeated measurements were used to compare mean changes in primary and secondary outcomes between intervention and control group of patients over time on an intention to treat basis. Potential efficiency was investigated from a societal perspective. Economic evaluation was based on general principles of a cost-effectiveness analysis. Outcome measures for health economic evaluation, were costs, and Quality Adjusted Life Years (QALYs). Results Half of the intended number of patients were recruited. There was no statistically significant treatment effect found in the MANSA (0.17, 95%-CI [− 0.058,0.431], p = 0.191). Treatment effects showed significant improvement in the Different Doctor-Patient Relationship Questionnaire-scores and a significant increase in the Illness Management and Recovery–scale Client-version scores). No effects of ICPT on societal and medical costs nor QALYs were found. Conclusions This is the first RCT to investigate the (cost)-effectiveness of ICPT. Compared with CAU, ICPT did not improve quality of life, but significantly reduced clinician-perceived difficulty, and increased subjective illness management and recovery. No effects on costs or QALY’s were found. Trial registration NTR 3988 , registered 13 May 2013.

Abstract Background Various rehabilitation services and return-to-work programs have been developed in order to reduce sickness absence and increase sustainable return-to-work. To ensure that people with a high risk of not returning to work can participate in working life, the model of work-related medical rehabilitation was developed in Germany. The efficacy of these programs in patients with mental disorders has been tested in only a few trials with very specific intervention approaches. To date, there is no clear evidence of the effectiveness of work-related medical rehabilitation implemented in real-care practice. Methods/design Our randomized controlled trial will be conducted in six rehabilitation centers across Germany. Within 15 months, 1800 patients with mental disorders (300 per rehabilitation center) will be recruited and assigned one-to-one either to a work-related medical rehabilitation program or to a conventional psychosomatic rehabilitation program. Participants will be aged 18–60 years. The control group will receive a conventional psychosomatic rehabilitation program without additional work-related components. The intervention group will receive a work-related medical rehabilitation program that contains at least 11 h of work-related treatment modules. Follow-up data will be assessed at the end of the rehabilitation and 3 and 12 months after completing the rehabilitation program. The primary outcome is a stable return to work. Secondary outcomes cover several dimensions of health, functioning and coping strategies. Focus groups and individual interviews supplement our study with qualitative data. Discussion This study will determine the relative effectiveness of a complex and newly implemented work-related rehabilitation strategy for patients with mental disorders. Trial registration German Clinical Trials Register ( DRKS00023175 , September 29 2020).

Abstract Background Video gaming is a promising intervention for cognitive and social impairment in patients with schizophrenia. A number of gaming interventions have been evaluated in small-scale studies with various patient groups, but studies on patients with schizophrenia remain scarce and rarely include the evaluation of both clinical and neurocognitive outcomes. In this study, we will test the effectiveness of two interventions with gaming elements to improve cognitive and clinical outcomes among persons with schizophrenia. Methods The participants will be recruited from different outpatient units (e.g., outpatient psychiatric units, day hospitals, residential care homes). The controlled clinical trial will follow a three-arm parallel-group design: 1) cognitive training (experimental group, CogniFit), 2) entertainment gaming (active control group, SIMS 4), and 3) treatment as usual. The primary outcomes are working memory function at 3-month and 6-month follow-ups. The secondary outcomes are patients’ other cognitive and social functioning, the ability to experience pleasure, self-efficacy, and negative symptoms at 3-month and 6-month follow-ups. We will also test the effectiveness of gaming interventions on neurocognitive outcomes (EEG and 3 T MRI plus rs-fMRI) at a 3-month follow-up as an additional secondary outcome. Data will be collected in outpatient psychiatric services in Hong Kong. Participants will have a formal diagnosis of schizophrenia and be between 18 and 60 years old. We aim to have a total of 234 participants, randomly allocated to the three arms. A sub-sample of patients (N = 150) will be recruited to undergo an EEG. For neuroimaging assessment, patients will be randomly allocated to a subset of patients (N=126). We will estimate the efficacy of the interventions on the primary and secondary outcomes based on the intention-to-treat principle. Behavioural and EEG data will be analysed separately. Discussion The study will characterise benefits of gaming on patients’ health and well-being, and contribute towards the development of new treatment approaches for patients with schizophrenia. Trial registration ClinicalTrials.gov NCT03133143 . Registered on April 28, 2017.

Background: People with mental illness have a reduced life expectancy compared to the general population. Despite the increasing evidence for the efficacy of lifestyle interventions there is little change in routine clinical care. This discrepancy is often referred to as the implementation gap and has caused a need for effectiveness and implementation research in real-world settings. Our study assesses the effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +). Methods: An open cohort stepped wedge cluster randomized trial in inpatients psychiatric wards of GGz Centraal, the Netherlands. The wards are divided into three clusters based on geographical region. These clusters are randomly allocated to one of the three pre-defined steps to integrate MULTI +. MULTI + can be tailored to fit individual psychiatric wards and includes 10 core components aimed at improving lifestyle factors. The primary outcome is to investigate the difference in the mean QRISK3 score of patients receiving MULTI + compared to patients receiving TAU. Secondary outcomes include somatic and mental health outcomes, lifestyle factors, and implementation factors. Findings will be analysed using mixed model analyses. Discussion: The MULTI + study is the first large-scale study evaluating the long-term effects of a multidisciplinary, multicomponent approach aimed at improving lifestyle factors in routine inpatient mental health care. A limitation of this study is the risk of missing data due to the large-scale, real-world setting of this study. Furthermore, implementation monitoring and external events that may influence outcomes could be difficult to account for. Strengths of this study are the focus on effectiveness as well as implementation and the inclusion of both patient and health care professionals' perspectives. Effectiveness studies in routine clinical care can advance our knowledge on lifestyle interventions in real-world settings. Trial registration: ClinicalTrials.gov registration. Identifier: NCT04922749. Retrospectively registered 3th of June 2021. [ABSTRACT FROM AUTHOR]

Background: Approximately one in ten men experience mental health difficulties during the early years of fatherhood, and these can have negative impacts on children and families. However, few evidence-based interventions targeting fathers' mental health are available. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of Working Out Dads (WOD) – a facilitated peer support group intervention for fathers of young children, in reducing psychological distress and other mental health symptoms. Methods: This trial will employ a parallel-arm randomised controlled trial (RCT) to evaluate the effectiveness and cost effectiveness of WOD peer support group intervention compared to usual care (a 30-min mental health and service focused phone consultation with a health professional). A total of 280 fathers of young children (aged 0-4 years) who are experiencing mental health difficulties and/or are at risk of poor mental health will be recruited. Randomisation and analyses will be at the level of the individual participant. The primary outcome is psychological distress symptoms, measured by the Kessler Psychological Distress Scale (K10) from baseline to 24 weeks post randomisation. A range of secondary outcomes will be assessed including suicidal ideation; mental health disorders, specific symptoms of depression, anxiety, and stress; social support, quality of life, health service use, and health care costs. Data will be collected at baseline, 10- and 24 weeks post-randomisation. Discussion: This trial will examine the effectiveness of a novel group-based peer support intervention in reducing the psychological distress and other mental health symptoms of fathers compared to usual care. The economic and process evaluation will guide policy decision making along with informing the future implementation of WOD on a larger scale if effectiveness is demonstrated. Trial registration: The current trial has been registered with ClinicalTrials.gov (Registration ID - NCT04813042). Date of Registration: March 22nd, 2021. [ABSTRACT FROM AUTHOR]

Background: Specialized evidence-based treatments have been developed and evaluated for borderline personality disorder (BPD), including Dialectical Behavior Therapy (DBT) and Schema Therapy (ST). Individual differences in treatment response to both ST and DBT have been observed across studies, but the factors driving these differences are largely unknown. Understanding which treatment works best for whom and why remain central issues in psychotherapy research. The aim of the present study is to improve treatment response of DBT and ST for BPD patients by a) identifying patient characteristics that predict (differential) treatment response (i.e., treatment selection) and b) understanding how both treatments lead to change (i.e., mechanisms of change). Moreover, the clinical effectiveness and cost-effectiveness of DBT and ST will be evaluated. Methods: The BOOTS trial is a multicenter randomized clinical trial conducted in a routine clinical setting in several outpatient clinics in the Netherlands. We aim to recruit 200 participants, to be randomized to DBT or ST. Patients receive a combined program of individual and group sessions for a maximum duration of 25 months. Data are collected at baseline until three-year follow-up. Candidate predictors of (differential) treatment response have been selected based on the literature, a patient representative of the Borderline Foundation of the Netherlands, and semi-structured interviews among 18 expert clinicians. In addition, BPD-treatment-specific (ST: beliefs and schema modes; DBT: emotion regulation and skills use), BPD-treatment-generic (therapeutic environment characterized by genuineness, safety, and equality), and non-specific (attachment and therapeutic alliance) mechanisms of change are assessed. The primary outcome measure is change in BPD manifestations. Secondary outcome measures include functioning, additional self-reported symptoms, and well-being. Discussion: The current study contributes to the optimization of treatments for BPD patients by extending our knowledge on "Which treatment – DBT or ST – works the best for which BPD patient, and why?", which is likely to yield important benefits for both BPD patients (e.g., prevention of overtreatment and potential harm of treatments) and society (e.g., increased economic productivity of patients and efficient use of treatments). Trial registration: Netherlands Trial Register, NL7699, registered 25/04/2019 - retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Traumatic stress is a global mental health problem requiring novel, easily implemented treatment solutions. We compared the effectiveness and efficiency of Reconsolidation Therapy (RT) to the well-established antidepressant paroxetine, in reducing symptoms of traumatic stress among patients from Nepal, a low-income country. Methods: Forty-six adults with posttraumatic stress disorder (PTSD) were randomized to one of two groups. The reconsolidation blocker propranolol was administered 90 min before briefly recalling a traumatic memory with a therapist, weekly for six consecutive weeks. This was compared to daily paroxetine for 26 weeks. Self-reported PTSD symptoms were assessed blindly at the 7th, 13th, and 26th weeks. Results: An intent-to-treat analysis revealed a robust pre- to post-treatment main effect (β1 = − 4.83, 95% CI = [− 5.66, − 4.01], p <.001), whereby both groups improved, with Cohen's effect sizes of d = 2.34 (95% CI = [1.57, 3.12]) for paroxetine, and of 2.82 (95% CI = [1.98, 3.66]) for RT after 7 weeks, suggesting treatment effectiveness for both groups in a real-world setting. Three and six-month follow-up yielded further significant improvement in both groups, which did not differ from each other. Conclusion: RT also displayed promising efficiency, considering that it had been discontinued weeks earlier while the paroxetine treatment was continued, as recommended. RT could be taught in low-income countries as part of the local therapeutic resources to treat the core symptoms of PTSD, provided that such results are replicated on a broader scale. Trial registration: ISRCTN34308454 (11/10/2017). [ABSTRACT FROM AUTHOR]

Abstract Background Due to long waiting periods for outpatient psychotherapy and the high resource requirements of inpatient treatment, there is a need for alternative treatment programs for patients with depressive disorders. Thus, we investigated the effectiveness of the “Bielefeld Outpatient Intensive Treatment Program of Depression” (BID) in comparison with a typical inpatient treatment program by using a prospective quasi-experimental observational study. We assumed (i) that both complex programs are effective in pre-post analyses after 6 weeks and (ii) that inpatient treatment is more effective compared with the outpatient program. Methods Four hundred patients with depressive psychopathology – a majority with depressive episodes (ICD-10 F3X) - took part in the BID and 193 in the inpatient program. Different self- (i.e., BDI) and expert measures (i.e., MADRS) of psychopathology at baseline (t1) and 6 weeks later (t2) were applied to examine treatment effects. Results Treatment effects were high in separate analyses of both groups with Cohen’s d ranging from 1.10 to 1.76., while ANOVA comparative analyses did not reveal any significant differences between both treatment settings nor did a set of independent covariates analyzed here. Response rates of BDI (p = .002) and MADRS (p = .001) were higher in the outpatient group. Results indicate BID not to be inferior compared to an inpatient program, although diverging pathways to treatment, higher rates of clinical recurrent depressive disorders and severe episodes as well as lower rates of employment and partnership in the inpatient treatment group have to be considered. Conclusion Outpatient intensive treatment programs may represent a solution for patients needing more than a treatment session once per week but less than a complex inpatient or day clinic program.

Abstract Background Peer-delivered services potentially provide broad, multifaceted benefits for persons suffering severe mental illness. Most studies to date have been conducted in countries with well-developed outpatient mental health systems. The objective of this study was to examine the feasibility for developing a community-based peer service in China. Methods Thirteen peer service providers and 54 consumers were recruited from four communities in Beijing. We initiated the program in two communities, followed by another two in order to verify and add to our understanding of potential scalable feasibility. Semi-structured face-to-face interviews were conducted 12 month after initiation at each site to measure satisfaction and perceived benefits from perspectives of peer service providers, and consumers and their caregivers. Results Key stakeholders reported that peer support services were satisfying and beneficial. Eleven of 13 peer service providers were willing to continue in their roles. Ten, 8, and 7 of them perceived improvements in working skills, social communication skills, and mood, respectively. Among consumers, 39 of 54 were satisfied with peer services. Improvements in mood, social communication skills, illness knowledge, and illness stability were detected among 23, 18, 13, and 13 consumers, respectively. For caregivers, 31 of 32 expressed a positive view regarding peer services. Caregivers reported improvement in their own mood, confidence in recovery of their family members, and reduction in caretaker burdens. Conclusions The findings highlight that peer-delivered services have promise in China for benefiting persons with severe mental illness and their family caregivers, as well as the peer service providers themselves.

Abstract Background Dementia represents a mental and economic burden for both patients and their caregivers. Therefore, the aim of this study is to explore the effectiveness of animal assisted therapy (AAT) with special focus on canis therapy among people with dementia, specifically Alzheimer’s disease. Methods The key method of this review study is a systematic review of the research studies detected in the Web of Science, Scopus and PubMed. The search was conducted for the studies dating from 2016 till 31 August 2018 because several review studies were published before. Eventually, only six studies were involved into the final analysis. Results The findings of this review, based on significant effect sizes, reveal that AAT may work as a beneficial and effective complementary treatment, especially in the area of behavioral and psychological symptoms, for patients with different degree of dementia severity if AAT is targeted at their specific needs and interests. Conclusions More research in the area of methodology for the implementation of AAT is necessary, and more research should be conducted with respect to the use of AAT for the improvement of cognitive functions in people with dementia.

Abstract Background Acceptance and Commitment Therapy (ACT) has been successfully established in hundreds of efficacy trials. It is less understood, however, how ACT works in real-world settings. Furthermore, little is known about how contextual variables such as treatment setting (inpatient vs. outpatient), social network and environment of the patient impact outcome. Methods This paper describes the methods of the Choose Change study that compares transdiagnostic inpatients (n = 85) and outpatients (n = 85) with varying degrees of treatment experience and treatment success (i.e., no previous treatment vs. previous remission vs. treatment-resistant). Patients received ACT during an intensive treatment phase lasting approximately twelve treatment sessions, and were accompanied up to twelve months following intensive treatment. Main outcomes include symptoms, functioning, and well-being. Multiple levels of data are investigated, including treatment context, weekly assessments, a behavioral approach test, multiple follow-up phases, and ambulatory assessment using Event Sampling Methodology, to examine patients’ daily context. Discussion We aim to investigate antecedents, consequences, and inherent processes that contribute to the maintenance or fluctuations of psychological disorders and the efficacy of ACT treatment. Furthermore, this study intends to increase understanding of how accurately participants can report on their own experiences, in order to expand our knowledge of how to probe for such information in the future. The results of Choose Change will provide basic clinical theory and clinical care with important and meaningful insights into the effectiveness of ACT, trans diagnostically, in in- and outpatients, and in a naturalistic setting. Trial registration This study was retrospectively registered in the ISRCTN Registry (registration number ISRCTN11209732) on May 20th 2016.

Abstract Background Suicide and non-fatal suicidal behavior are significant public health issues worldwide requiring effective preventive interventions. Methods The aim of the present study was to analyze the effectiveness of national suicide prevention programs taking a statistical approach involving the segmented regression analysis of interrupted time series data. Results This study demonstrates that National Suicide Prevention Programs are effective, but this effect seems to correlate with age and sex. Our data have shown a statistical significant decline in suicide rates in the verum countries in males, with the strongest effects in groups aged 25-to-44 years and 45-to-64 years. Conclusion Our study implies that the implementation of a national strategy is an effective tool to reduce suicide rates.

Background: Depressive disorders and problematic drinking often co-occur, also among young adults. These co-occurring conditions are associated with various negative health outcomes compared to both conditions alone. Early intervention by addressing alcohol use and depressive symptoms simultaneously in the same treatment might improve both conditions. However, evidence on the (cost-) effectiveness of digital combined depression and alcohol interventions for young adults is currently insufficient. We therefore developed an add-on digital alcohol moderation adherence-focussed guided intervention to complement treatment as usual (TAU) for depressive disorders. The digital intervention is a web-app, including 6 modules based on motivational interviewing and cognitive behavioural therapy. This study aims to evaluate the (cost-)effectiveness of a digital alcohol moderation intervention + TAU compared to TAU on alcohol and depression outcomes among young adults with co-occurring depressive disorders and problematic alcohol use. Methods: One hundred fifty-six participants, aged 18–35 years, with problematic alcohol use and a diagnosed depressive disorder will participate in a pragmatic multicentre two-arm randomized controlled trial. Problematic alcohol use is operationalised as scoring ≥5 for women and ≥ 8 for men on the Alcohol Use Disorder Identification Test (AUDIT). Participants will be randomized to either the experimental group (digital alcohol intervention + TAU) or control group (TAU only). Participants will be recruited at three Dutch mental health care centres and through social media. Assessments take place at baseline and after 3, 6 and 12 months post-randomization. The primary outcome is treatment response at 6-month follow-up, operationalized as a composite score that combines alcohol use and depression measures and indicates whether treatment has been successful or not. Secondary outcomes are depressive symptoms and alcohol use (i.e. number of weekly standard drinks and AUDIT score). An economic evaluation will be conducted alongside the trial. Discussion: This study evaluates the (cost-) effectiveness of an add-on digital alcohol moderation intervention for young adults who are in treatment for depressive disorders. If proven effective, the digital intervention could be implemented in mental health care and improve treatment for people with co-occurring depressive disorders and problematic alcohol use. Trial registration: Pre-registered on October 29, 2019 in The Netherlands Trial Register (NL8122). [ABSTRACT FROM AUTHOR]

Background: Long-term community mental health treatment for non-psychotic disorder patients with severe mental illness (SMI) who are perceived as difficult by clinicians, is poorly developed and lacks a structured, goal-centred approach. This study compares (cost-)effectiveness of Interpersonal Community Psychiatric Treatment (ICPT) with Care As Usual (CAU) on quality of life and clinician perceived difficulty in the care for non-psychotic disorder SMI-patients. A multi-centre cluster-randomized clinical tria was conducted in which Community Mental Health Nurses (Clinicians) in three large community mental health services in the Netherlands were randomly allocated to providing either ICPT or CAU to included patients. A total of 56 clinicians were randomized, who treated a total of 93 patients (59 in ICPT-group and 34 in CAU-group). Methods: Primary outcome measure is patient-perceived quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcome measures include clinician-perceived difficulty, general mental health, treatment outcomes, illness management and recovery, therapeutic relationship, care needs and social network. Patients were assessed at baseline, during treatment (6 months), after treatment (12 months) and at 6 months follow-up (18 months). Linear mixed-effects models for repeated measurements were used to compare mean changes in primary and secondary outcomes between intervention and control group of patients over time on an intention to treat basis. Potential efficiency was investigated from a societal perspective. Economic evaluation was based on general principles of a cost-effectiveness analysis. Outcome measures for health economic evaluation, were costs, and Quality Adjusted Life Years (QALYs). Results: Half of the intended number of patients were recruited. There was no statistically significant treatment effect found in the MANSA (0.17, 95%-CI [− 0.058,0.431], p = 0.191). Treatment effects showed significant improvement in the Different Doctor-Patient Relationship Questionnaire-scores and a significant increase in the Illness Management and Recovery–scale Client-version scores). No effects of ICPT on societal and medical costs nor QALYs were found. Conclusions: This is the first RCT to investigate the (cost)-effectiveness of ICPT. Compared with CAU, ICPT did not improve quality of life, but significantly reduced clinician-perceived difficulty, and increased subjective illness management and recovery. No effects on costs or QALY's were found. Trial registration: NTR 3988, registered 13 May 2013. [ABSTRACT FROM AUTHOR]

Background: Various rehabilitation services and return-to-work programs have been developed in order to reduce sickness absence and increase sustainable return-to-work. To ensure that people with a high risk of not returning to work can participate in working life, the model of work-related medical rehabilitation was developed in Germany. The efficacy of these programs in patients with mental disorders has been tested in only a few trials with very specific intervention approaches. To date, there is no clear evidence of the effectiveness of work-related medical rehabilitation implemented in real-care practice. Methods/design: Our randomized controlled trial will be conducted in six rehabilitation centers across Germany. Within 15 months, 1800 patients with mental disorders (300 per rehabilitation center) will be recruited and assigned one-to-one either to a work-related medical rehabilitation program or to a conventional psychosomatic rehabilitation program. Participants will be aged 18–60 years. The control group will receive a conventional psychosomatic rehabilitation program without additional work-related components. The intervention group will receive a work-related medical rehabilitation program that contains at least 11 h of work-related treatment modules. Follow-up data will be assessed at the end of the rehabilitation and 3 and 12 months after completing the rehabilitation program. The primary outcome is a stable return to work. Secondary outcomes cover several dimensions of health, functioning and coping strategies. Focus groups and individual interviews supplement our study with qualitative data. Discussion: This study will determine the relative effectiveness of a complex and newly implemented work-related rehabilitation strategy for patients with mental disorders. Trial registration: German Clinical Trials Register (DRKS00023175, September 29 2020). [ABSTRACT FROM AUTHOR]

Abstract Background Evidence is accumulating that Cognitive Remediation Training (CRT) is effective for ameliorating cognitive deficits experienced by patients with schizophrenia and accompanying functional impairment. There has been no randomized controlled trial of CRT using a nationally representative population of forensic patients, despite the significant cognitive deficits frequently present within this group. Methods Sixty-five patients with schizophrenia or schizoaffective disorder were enrolled in a single blind randomized controlled trial of CRT versus treatment as usual (TAU); representing 94% of those eligible within a national forensic cohort. The primary outcome measure was the composite score of the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcome measures included neurocognitive and social cognitive domains, symptoms, and ‘real world’ functioning. Patient satisfaction was examined using an exit interview. Participants were reassessed at 8 months follow up. All data were analyzed using an intention to treat design (ITT). Results For the primary outcome measure, the MCCB composite score, there were significant differences between those who participated in CRT and those receiving TAU at both end of treatment and 8 months follow up (Cohen’s d = 0.34. Significant improvements were observed in visual and working memory. Mediation analysis found that those who cognitively benefited from CRT had corresponding improved functioning, and more net positive therapeutic moves i.e. moves to units with lower security within the hospital. Ninety-six percent believed their cognitive gains positively affected their daily lives. Conclusions CRT may be an acceptable and efficacious intervention for forensic patients with schizophrenia or schizoaffective disorder. Trial registration ClinicalTrials.gov Identifier: NCT02360813. Trial registered Feb 4th 2015, last updated May 1st 2015.

Abstract Background Suicide bereavement is a risk factor for adverse outcomes related to grief, social functioning, mental health and suicidal behaviour. Consequently, suicide bereavement support (i.e., postvention) has been identified as an important suicide prevention strategy. However, little is known about its effectiveness. To redress this gap, this review aimed to assess the evidence of effectiveness of interventions for people bereaved by suicide, and appraise the quality of the research in this field. Methods We conducted a systematic review according to PRISMA guidelines. Searches of peer-reviewed literature in Medline, PsycINFO, Embase and EBM Reviews identified 12 papers reporting on 11 relevant studies conducted between 1984 and 2018. Results Across studies, there was a wide variety of intervention modalities, study populations, control groups, and grief, psychosocial and suicide-related outcome measures. Overall, the quality of studies was weak. While there was some evidence of the effectiveness of interventions for uncomplicated grief, evidence of the effectiveness of complicated grief interventions was lacking. Based on this scant evidence, interventions which seem to show promise include supportive, therapeutic and educational approaches, involve the social environment of the bereaved, and comprise a series of sessions led by trained facilitators. Conclusions There is a clear need for additional methodologically sound studies in this area. Specifically, selection procedures, sample sizes, randomization, and the use of appropriate measures are crucial. As people bereaved by suicide are at-risk of adverse grief, mental ill-health and suicidal behaviour, further research across the life-span is essential to prevent grief and mental health ramifications.

Abstract Background German statutory health insurances are pursuing the goal of improving treatment of chronically ill people by promoting networks of health care providers and supporting treatments that reflect the current medical knowledge. The so-called PNP program is a collaborative care program developed by a German statutory health insurance, which defines specific rules on psychiatric, neurological, psychosomatic, and psychotherapeutic treatment. It aims to strengthen provision of guideline-based outpatient treatment and collaboration between different health care providers. It includes the general practitioners’ program, which aims to strengthen the coordinating role of GPs. This study aims to evaluate the PNP program. Methods To evaluate the effectiveness of the PNP program, we will conduct a prospective non-randomized controlled trial with primary data comparing patients enrolled in the PNP program and in the general practitioner program (intervention group) to patients enrolled only in the general practitioner program and patients who receive usual care (control groups). To evaluate costs and level of detail of diagnoses in care of patients with PNP program, we will use routinely collected secondary administrative health data in a retrospective quasi-experimental design. Patients who are at least 18 years old, insured by the statutory health insurance AOK, and on sick leave due to one of the mental or neurological diagnoses (affective, anxiety, somatoform or adjustment disorders, alcohol use disorders, schizophrenia, multiple sclerosis) will be included. We will collect data at baseline and at 12-months follow-up. Health-related quality of life (primary data) and direct costs (secondary data) caused by outpatient and inpatient service utilization and medication will be the primary outcomes. We will analyze data using (generalized) linear mixed models and exploratory analyses. We will use entropy balancing to control for possible differences between the groups. We will use an exploratory sequential design including qualitative and descriptive statistical analyses to assess the structure and process quality of the PNP program among health care providers. Discussion The results will help to develop a comprehensive picture of collaborative care programs for mental and neurological health care from the perspective of patients, health care providers, and health insurance companies. Trial registration German Clinical Trial Register DRKS00013114

Abstract Background Post-deinstitutionalisation, mental health supported accommodation services have been implemented widely. The available research evidence is heterogeneous in nature and resistant to synthesis attempts, leaving researchers and policy makers with no clear summary what works and for whom. In this context, we undertook a comprehensive systematic review of quantitative studies in order to synthesise the current evidence on mental health and psychosocial outcomes for individuals residing in mental health supported accommodation services. Methods Using a combination of electronic database searches, hand searches, forward-backward snowballing and article recommendations from an expert panel, 115 papers were identified for review. Data extraction and quality assessments were conducted, and 33 articles were excluded due to low quality, leaving 82 papers in the final review. Variation in terminology and service characteristics made the comparison of service models unfeasible. As such, findings were presented according to the following sub-groups: ‘Homeless’, ‘Deinstitutionalisation’ and ‘General Severe Mental Illness (SMI)’. Results Results were mixed, reflecting the heterogeneity of the supported accommodation literature, in terms of research quality, experimental design, population, service types and outcomes assessed. There is some evidence that supported accommodation is effective across a range of psychosocial outcomes. The most robust evidence supports the effectiveness of the permanent supported accommodation model for homeless SMI in generating improvements in housing retention and stability, and appropriate use of clinical services over time, and for other forms of supported accommodation for deinstitutionalised populations in reducing hospitalisation rates and improving appropriate service use. The evidence base for general SMI populations is less developed, and requires further research. Conclusions A lack of high-quality experimental studies, definitional inconsistency and poor reporting continue to stymie our ability to identify effective supported accommodation models and practices. The authors recommend improved reporting standards and the prioritisation of experimental studies that compare outcomes across different service models.

Abstract Background Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. Methods A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. Discussion The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet-based intervention for AjD in the Spanish population. Trial registration ClinicalTrial.gov: NCT02758418. Trial registration date 2 May 2016.

Background: Video gaming is a promising intervention for cognitive and social impairment in patients with schizophrenia. A number of gaming interventions have been evaluated in small-scale studies with various patient groups, but studies on patients with schizophrenia remain scarce and rarely include the evaluation of both clinical and neurocognitive outcomes. In this study, we will test the effectiveness of two interventions with gaming elements to improve cognitive and clinical outcomes among persons with schizophrenia. Methods: The participants will be recruited from different outpatient units (e.g., outpatient psychiatric units, day hospitals, residential care homes). The controlled clinical trial will follow a three-arm parallel-group design: 1) cognitive training (experimental group, CogniFit), 2) entertainment gaming (active control group, SIMS 4), and 3) treatment as usual. The primary outcomes are working memory function at 3-month and 6-month follow-ups. The secondary outcomes are patients' other cognitive and social functioning, the ability to experience pleasure, self-efficacy, and negative symptoms at 3-month and 6-month follow-ups. We will also test the effectiveness of gaming interventions on neurocognitive outcomes (EEG and 3 T MRI plus rs-fMRI) at a 3-month follow-up as an additional secondary outcome. Data will be collected in outpatient psychiatric services in Hong Kong. Participants will have a formal diagnosis of schizophrenia and be between 18 and 60 years old. We aim to have a total of 234 participants, randomly allocated to the three arms. A sub-sample of patients (N = 150) will be recruited to undergo an EEG. For neuroimaging assessment, patients will be randomly allocated to a subset of patients (N=126). We will estimate the efficacy of the interventions on the primary and secondary outcomes based on the intention-to-treat principle. Behavioural and EEG data will be analysed separately. Discussion: The study will characterise benefits of gaming on patients' health and well-being, and contribute towards the development of new treatment approaches for patients with schizophrenia. Trial registration: ClinicalTrials.gov NCT03133143. Registered on April 28, 2017. [ABSTRACT FROM AUTHOR]

Abstract Background In the Republic of Ireland, borderline personality disorder (BPD) is a feature of approximately 11–20% of clinical presentations to outpatient clinics within mental health services. These estimates are similar to other countries including the UK and USA. Dialectical behaviour therapy (DBT) is an intervention with a growing body of evidence that demonstrates its efficacy in treating individuals diagnosed with BPD. While a number of randomised controlled trials (RCTs) have demonstrated the efficacy of DBT, there is limited research which evaluates the effectiveness of this model when applied to real world settings. Funding was secured to co-ordinate DBT training in public community-based mental health services across Ireland. As no other study has evaluated a co-ordinated national implementation of DBT, the current study proposes to investigate the effectiveness of DBT in both adult and child/adolescent community mental health services across Ireland, evaluate the coordinated implementation of DBT at a national level, and complete a comprehensive economic evaluation comparing DBT versus treatment-as-usual. Methods/ design This study takes the form of a quasi-experimental design. Individuals attending community mental health services who meet criteria for participation in the DBT programme will be allocated to the intervention group. Individuals who live in areas in Ireland where DBT is not yet available, and individuals who choose not to participate in the intervention, will be invited to participate in a treatment-as-usual comparison group. Self-report clinical measures and health service use questionnaires for DBT participants (and parent/guardians as appropriate) will be administered at pre-, mid- and post-intervention, as well as follow-up for participants who complete the intervention. Survey and interview data for DBT therapists will be gathered at three time points: prior to DBT training, 6 months after teams begin delivery of the intervention, and 2 years following training completion. Discussion It is anticipated that the results of this study will provide evidence for the effectiveness of DBT for patients, and report on recommendations regarding best practice guidelines for implementation of DBT and its economic merit in a publicly funded service. Trial registration ClinicalTrials.gov ID: NCT03180541; Registered June 7th 2017 ‘retrospectively registered’.

Abstract Background Cognitive Behaviour Therapy (CBT) is the front-line psychological intervention for step 3 within UK psychological therapy services. Counselling is recommended only when other interventions have failed and its effectiveness has been questioned. Method A secondary data analysis was conducted of data collected from 33,243 patients across 103 Improving Access to Psychological Therapies (IAPT) services as part of the second round of the National Audit of Psychological Therapies (NAPT). Initial analysis considered levels of pre-post therapy effect sizes (ESs) and reliable improvement (RI) and reliable and clinically significant improvement (RCSI). Multilevel modelling was used to model predictors of outcome, namely patient pre-post change on PHQ-9 scores at last therapy session. Results Counselling received more referrals from patients experiencing moderate to severe depression than CBT. For patients scoring above the clinical cut-off on the PHQ-9 at intake, the pre-post ES (95% CI) for CBT was 1.59 (1.58, 1.62) with 46.6% making RCSI criteria and for counselling the pre-post ES was 1.55 (1.52, 1.59) with 44.3% of patients meeting RCSI criteria. Multilevel modelling revealed a significant site effect of 1.8%, while therapy type was not a predictor of outcome. A significant interaction was found between the number of sessions attended and therapy type, with patients attending fewer sessions on average for counselling [M = 7.5 (5.54) sessions and a median (IQR) of 6 (3–10)] than CBT [M = 8.9 (6.34) sessions and a median (IQR) of 7 (4–12)]. Only where patients had 18 or 20 sessions was CBT significantly more effective than counselling, with recovery rates (95% CIs) of 62.2% (57.1, 66.9) and 62.4% (56.5, 68.0) respectively, compared with 44.4% (32.7, 56.6) and 42.6% (30.0, 55.9) for counselling. Counselling was significantly more effective at two sessions with a recovery rate of 34.9% (31.9, 37.9) compared with 22.2% (20.5, 24.0) for CBT. Conclusions Outcomes for counselling and CBT in the treatment of depression were comparable. Research efforts should focus on factors other than therapy type that may influence outcomes, namely the inherent variability between services, and adopt multilevel modelling as the given analytic approach in order to capture the naturally nested nature of the implementation and delivery of psychological therapies. It is of concern that half of all patients, regardless of type of intervention, did not show reliable improvement.

Background: Peer-delivered services potentially provide broad, multifaceted benefits for persons suffering severe mental illness. Most studies to date have been conducted in countries with well-developed outpatient mental health systems. The objective of this study was to examine the feasibility for developing a community-based peer service in China. Methods: Thirteen peer service providers and 54 consumers were recruited from four communities in Beijing. We initiated the program in two communities, followed by another two in order to verify and add to our understanding of potential scalable feasibility. Semi-structured face-to-face interviews were conducted 12 month after initiation at each site to measure satisfaction and perceived benefits from perspectives of peer service providers, and consumers and their caregivers. Results: Key stakeholders reported that peer support services were satisfying and beneficial. Eleven of 13 peer service providers were willing to continue in their roles. Ten, 8, and 7 of them perceived improvements in working skills, social communication skills, and mood, respectively. Among consumers, 39 of 54 were satisfied with peer services. Improvements in mood, social communication skills, illness knowledge, and illness stability were detected among 23, 18, 13, and 13 consumers, respectively. For caregivers, 31 of 32 expressed a positive view regarding peer services. Caregivers reported improvement in their own mood, confidence in recovery of their family members, and reduction in caretaker burdens. Conclusions: The findings highlight that peer-delivered services have promise in China for benefiting persons with severe mental illness and their family caregivers, as well as the peer service providers themselves. [ABSTRACT FROM AUTHOR]

Background: Suicide bereavement is a risk factor for adverse outcomes related to grief, social functioning, mental health and suicidal behaviour. Consequently, suicide bereavement support (i.e., postvention) has been identified as an important suicide prevention strategy. However, little is known about its effectiveness. To redress this gap, this review aimed to assess the evidence of effectiveness of interventions for people bereaved by suicide, and appraise the quality of the research in this field. Methods: We conducted a systematic review according to PRISMA guidelines. Searches of peer-reviewed literature in Medline, PsycINFO, Embase and EBM Reviews identified 12 papers reporting on 11 relevant studies conducted between 1984 and 2018. Results: Across studies, there was a wide variety of intervention modalities, study populations, control groups, and grief, psychosocial and suicide-related outcome measures. Overall, the quality of studies was weak. While there was some evidence of the effectiveness of interventions for uncomplicated grief, evidence of the effectiveness of complicated grief interventions was lacking. Based on this scant evidence, interventions which seem to show promise include supportive, therapeutic and educational approaches, involve the social environment of the bereaved, and comprise a series of sessions led by trained facilitators. Conclusions: There is a clear need for additional methodologically sound studies in this area. Specifically, selection procedures, sample sizes, randomization, and the use of appropriate measures are crucial. As people bereaved by suicide are at-risk of adverse grief, mental ill-health and suicidal behaviour, further research across the life-span is essential to prevent grief and mental health ramifications. [ABSTRACT FROM AUTHOR]

Background: The majority of patients with depressive disorders are treated by general practitioners (GPs) and are prescribed antidepressant medication. Patients prefer psychological treatments but they are under-used, mainly due to time constraints and limited accessibility. A promising approach to deliver psychological treatment is blended care, i.e. guided online treatment. However, the cost-effectiveness of blended care formatted as an online psychological treatment supported by the patients' own GP or general practice mental health worker (MHW) in routine primary care is unknown. We aim to demonstrate non-inferiority of blended care compared with usual care in patients with depressive symptoms or a depressive disorder in general practice. Additionally, we will explore the real-time course over the day of emotions and affect, and events within individuals during treatment. Methods: This is a pragmatic non-inferiority trial including 300 patients with depressive symptoms, recruited by collaborating GPs and MHWs. After inclusion, participants are randomized to either blended care or usual care in routine general practice. Blended care consists of the 'Act and Feel' treatment: an eight-week web-based program based on behavioral activation with integrated monitoring of depressive symptomatology and automatized feedback. GPs or their MHWs coach the participants through regular face-to-face or telephonic consultations with at least three sessions. Depressive symptomatology, health status, functional impairment, treatment satisfaction, daily activities and resource use are assessed during a follow-up period of 12 months. During treatment, real-time fluctuations in emotions and affect, and daily events will be rated using ecological momentary assessment. The primary outcome is the reduction of depressive symptoms from baseline to three months follow-up. We will conduct intention-to-treat analyses and supplementary per-protocol analyses. Discussion: This trial will show whether blended care might be an appropriate treatment strategy for patients with depressive symptoms and depressive disorder in general practice. [ABSTRACT FROM AUTHOR]

Background: Cognitive Behaviour Therapy (CBT) is the front-line psychological intervention for step 3 within UK psychological therapy services. Counselling is recommended only when other interventions have failed and its effectiveness has been questioned. Method: A secondary data analysis was conducted of data collected from 33,243 patients across 103 Improving Access to Psychological Therapies (IAPT) services as part of the second round of the National Audit of Psychological Therapies (NAPT). Initial analysis considered levels of pre-post therapy effect sizes (ESs) and reliable improvement (RI) and reliable and clinically significant improvement (RCSI). Multilevel modelling was used to model predictors of outcome, namely patient pre-post change on PHQ-9 scores at last therapy session. Results: Counselling received more referrals from patients experiencing moderate to severe depression than CBT. For patients scoring above the clinical cut-off on the PHQ-9 at intake, the pre-post ES (95% CI) for CBT was 1.59 (1. 58, 1.62) with 46.6% making RCSI criteria and for counselling the pre-post ES was 1.55 (1.52, 1.59) with 44.3% of patients meeting RCSI criteria. Multilevel modelling revealed a significant site effect of 1.8%, while therapy type was not a predictor of outcome. A significant interaction was found between the number of sessions attended and therapy type, with patients attending fewer sessions on average for counselling [M = 7.5 (5.54) sessions and a median (IQR) of 6 (3-10)] than CBT [M = 8.9 (6.34) sessions and a median (IQR) of 7 (4-12)]. Only where patients had 18 or 20 sessions was CBT significantly more effective than counselling, with recovery rates (95% CIs) of 62.2% (57.1, 66.9) and 62.4% (56.5, 68.0) respectively, compared with 44.4% (32.7, 56.6) and 42.6% (30.0, 55.9) for counselling. Counselling was significantly more effective at two sessions with a recovery rate of 34.9% (31.9, 37.9) compared with 22.2% (20.5, 24.0) for CBT. Conclusions: Outcomes for counselling and CBT in the treatment of depression were comparable. Research efforts should focus on factors other than therapy type that may influence outcomes, namely the inherent variability between services, and adopt multilevel modelling as the given analytic approach in order to capture the naturally nested nature of the implementation and delivery of psychological therapies. It is of concern that half of all patients, regardless of type of intervention, did not show reliable improvement. [ABSTRACT FROM AUTHOR]

Background: Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. Methods: This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted from a societal and public health perspective. Discussion: This is the first study examining an IMI for depression prevention in a sample of chronic pain patients. If this implementation of a depression prevention IMI into orthopedic aftercare proves effective, the intervention could be integrated into routine care with minimal costs and extended for use with other chronic diseases. Results will have implications for researchers, health care providers and public health policy makers. Trial registration: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00007960. Registered 12 August 2015. [ABSTRACT FROM AUTHOR]