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Background: Sleep disorders are a risk factor for developing a variety of mental disorders, have a negative impact on their remission rates and increase the risk of relapse. Early identification and treatment of sleep disorders is therefore of paramount importance. Unfortunately, in mental health care sleep disorders are often poorly recognized and specific treatment frequently occurs late or not at all. This protocol-paper presents a randomized controlled trial investigating the clinical relevance of early detection and treatment of sleep disorders in mental health care. The two aims of this project are 1) to determine the prevalence of sleep disorders in different mental disorders, and 2) to investigate the contribution of early identification and adequate treatment of sleep disorders in individuals with mental disorders to their sleep, mental disorder symptoms, general functioning, and quality of life. Methods: Patients newly referred to a Dutch mental health institute for psychiatric treatment will be screened for sleep disorders with the self-assessment Holland Sleep Disorders Questionnaire (HSDQ). Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder. Participants will be randomly assigned to two groups: Immediate sleep diagnostics and intervention (TAU+SI-T0), or delayed start of sleep intervention (TAU+SI-T1; 6 months after inclusion). The effect of sleep treatment as add-on to treatment as usual (TAU) will be tested with regard to sleep disorder symptoms, general functioning, and quality of life (in collaboration with a psychiatric sleep centre). Discussion: This trial will examine the prevalence of different sleep disorders in a broad range of mental disorders, providing information on the co-occurrence of specific sleep and mental disorders. Further, this study is the first to investigate the impact of early treatment of sleep disorders on the outcome of many mental disorders. Moreover, standard sleep interventions will be tailored to specific mental disorders, to increase their efficacy. The results of this trial may contribute considerably to the improvement of mental health care. Trial registration: This clinical trial has been retrospectively registered in the Netherlands Trial Register (NL8389; https://www.trialregister.nl/trial/8389) on February 2th, 2020. [ABSTRACT FROM AUTHOR]

Background: Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. Acupuncture (AC), as a minimally invasive technique, has become a popular choice for improving depression symptoms. However, it is still unclear which therapy is associated with the best outcomes for PSD. In this review, we aimed to explore the impact of AC in alleviating symptoms of PSD and to evaluate the difference in effectiveness between AC combined with pharmacotherapies and various non-pharmacotherapies. Methods: Six databases and three clinical trials registration platforms were searched from inception to March 2023. Randomized clinical trial comparing needle-based AC with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies, and collected data using a pre-made form. A Bayesian network meta-analysis was conducted to assess and compare different techniques using RStudio 3.6.0 with the package 'GEMTC' V.0.8.1. The primary outcome was the efficacy for PSD assessed by scales measuring depressive symptoms. The secondary outcomes were effectiveness for neurological function and the quality of life. The ranking probabilities for all treatment interventions was performed using the Surface Under the Cumulative Ranking curve (SUCRA). The risk of bias was assessed by using the Revised Cochrane Risk of Bias tool 2. Results: Sixty-two studies, involving 5308 participants published from 2003 to 2022, were included. The results showed that compared with western medicine (WM) (defined as pharmacotherapy for PSD), AC alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, AC alone or plus other therapies could significantly decrease scores on the Hamilton Depression Rating scale. According to result of SUCRA, AC plus RTMS had the highest probability of improving depressive symptoms with a probability of 49.43%. Conclusions: The results of this study indicate that AC alone or combined with other therapies appears to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison to WM, AC alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms of PSD. Also, AC with RTMS seems to be the most effective with the highest probability. Registration: This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database in November 2020 and updated in July 2021. The registration number is CRD42020218752. [ABSTRACT FROM AUTHOR]

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

Background: 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]

Background: The objectives of this research were to gain insights on the interactive effects, by measuring familial and peer-related risk factors in youths with oppositional defiant disorder (ODD). Methods: Participants were college students recruited nationwide, with age between 18 and 25. Through the consensus of expert meetings, a set of questionnaires were used to evaluate the familial status, participant's peer group conditions, high-risk environment of illicit substance use, and oppositional symptoms. The logistic regression was performed to see the independent and interactive risk factors for ODD. Results: A total of 981 subjects were enrolled. Six variables significantly associated with ODD at the multivariate logistic regression, including male, night division, poor academic performance, high risk environment, peer with illicit substance use and high maternal education level. High maternal education exerted independent protective effect on the development of ODD (adjusted odds ratio, aOR = 0.65, 95% CI = 0.44–0.99). Peer with illicit substance use was more likely to associate with ODD in the low maternal education group. The 2-way interactive effect of maternal education and peer with substance use on the development of ODD was OR = 4.96 (2.96, 8.31). Conclusion: The present study highlights the influence of maternal education level to ODD and its interaction with peer of illicit substance use. Our findings imply that the familial attachment and peer interaction are essential stages for the development of human behavior. Trial registration: The research protocol was reviewed and approved by the ethical review committee of National Taiwan University Hospital (number 201505057RINC) and registered at clinical trial systems at National Taiwan University. In addition, subjects' information was anonymous and de-identified prior to any analysis. [ABSTRACT FROM AUTHOR]

Background: The present study was designed to evaluate the efficacy of a therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention for service members of the German Armed Forces with posttraumatic stress disorder (PTSD). The iCBT was adapted from Interapy, a trauma-focused evidence-based treatment based on prolonged exposure and cognitive restructuring. It lasted for 5 weeks and included 10 writing assignments (twice a week). The program included a reminder function if assignments were overdue, but no multimedia elements. Therapeutic written feedback was provided asynchronously within one working day. Methods: Male active and former military service members were recruited from the German Armed Forces. Diagnoses were assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Mini-International Neuropsychiatric Interview. Psychopathology was assessed at pre-treatment, post-treatment, and 3-month follow-up. Severity of PTSD was the primary outcome and anxiety was the secondary outcome. Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks. Due to the overall small sample size (n = 37), the two groups were collapsed for the statistical analyses. Change during the intervention period was investigated using latent-change score models. Results: Improvements in the CAPS-5 were small and not statistically significant. For anxiety, small significant improvements were observed from pre- to follow-up assessment. The dropout rate was 32.3%. Conclusions: The low treatment utilization and the high dropout rate are in line with previous findings on treatment of service members. The interpretation of the current null results for the efficacy of iCBT is limited due to the small sample size, however for military samples effect estimates were also smaller in other recent studies. Our results demonstrate the need to identify factors influencing treatment engagement and efficacy in veterans. Trial registration: Australian Clinical Trials Registry ACTRN12616000956404. [ABSTRACT FROM AUTHOR]

Background: The Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that has been shown to reduce suicidal ideation and overall symptom distress. CAMS has not been previously evaluated in a standard acute inpatient mental health care setting with only short treatment times for suicidal patients. In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable. We are also investigating depressive symptoms, general symptom relief, and the quality of the therapeutic alliance as secondary outcomes. Methods/Design: This RCT is designed as a single-center, two-armed, parallel group observer-blinded clinical effectiveness investigation. We are recruiting and randomizing 60 participants with different diagnoses, who are admitted as inpatients because of acute suicidal thoughts or behaviors into the Clinic for Psychiatry and Psychotherapy, Ev. Hospital Bethel in Bielefeld, Germany. The duration of treatment will vary depending on patients' needs and clinical assessments ranging between 10 and 40 days. Patients are assessed four times, at admission, discharge, 1 month, and 5 months post-discharge. The primary outcome measure is the Beck Scale for Suicide Ideation. Other outcome measures are administered as assessment timepoints including severity of psychiatric symptoms, depression, reasons for living, and therapeutic relationship. Discussion: This effectiveness study is being conducted on an acute ward in a psychiatric clinic where patients have multiple problems and diagnoses. Treatment is somewhat limited, and therapists have a large caseloads. The results of this study can thus be generalizable to a typical inpatient psychiatric hospital settings. Trial registration: This clinical trial has been retrospectively registered with the German Clinical Trials Register; registration code/ DRKS-ID: DRKS00013727 (on January 12, 2018). In addition, the study was also registered with the International Clinical Trials Registry Platform of the World Health Organization (identical registration code). Registry Name: „Evaluation von CAMS versus TAU bei suizidalen Patienten – Ein stationärer RCT". [ABSTRACT FROM AUTHOR]

Background: Preoperative anxiety comprising anesthesia and surgery related anxiety is common and perceived by many patients as the worst aspect of the surgical episode. The aim of this study was to identify independent predictors of these three anxieties dimensions and to quantify the relevance of specific fears particularly associated with anesthesia. Methods: This study was part of a cross-sectional survey in patients scheduled to undergo elective surgery. Anxiety levels were measured with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Modified numeric rating scales (mNRS, range 0–10) were used to assess the severity of eight selected specific fears which were predominantly analyzed descriptively. Multivariate stepwise linear regression was applied to determine independent predictors of all three anxiety dimensions (APAIS anxiety subscales). Results: 3087 of the 3200 enrolled patients were analyzed. Mean (SD) total preoperative anxiety (APAIS-A-T, range 4–20) was 9.9 (3.6). High anxiety (APAIS-A-T > 10) was reported by 40.5% of subjects. Mean (SD) levels of concern regarding the eight studied specific fears ranged from 3.9 (3.08) concerning "Anesthesiologist error" to 2.4 (2.29) concerning "Fatigue and drowsiness" with an average of 3.2 (2.84) concerning all specific fears. Ranking of all specific fears according to mean mNRS scores was almost identical in patients with high versus those with low anxiety. Among nine independent predictors of anxiety, only 3 variables (female gender, negative and positive anesthetic experience) independently predicted all three APAIS anxiety subscales. Other variables had a selective impact on one or two APAIS anxiety subscales only. Female gender had the strongest impact on all three APAIS anxiety subscales. Adjusted r2 values of the three models were all below 13%. Conclusions: The high variability of importance assigned to all specific fears suggests an individualized approach is advisable when support of anxious patients is intended. Considering independent predictors of anxiety to estimate each patient's anxiety level is of limited use given the very low predictive capacity of all three models. The clinical benefit of dividing patients into those with high and low anxiety is questionable. Trial registration: German Registry of Clinical Trials (DRKS00016725), retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Accurate diagnosis of delirium is very important for prevention and treatment. Present study was designed to validate the 3-Minute Diagnostic Interview for CAM-defined Delirium Chinese version (3D-CAM-CN) in surgical ICU patients. Methods: In this prospective diagnostic study, the 3D-CAM was translated into Chinese with culture adaption. Two interviewers (Roles A and B) independently administrated 3D-CAM-CN assessment in adult patients from postoperative days 1 to day 3. At the meantime, a panel of psychiatrists diagnosed delirium according to the Diagnostic and Statistical Manual of Mental Disorders-fifth edition as the reference standard. The sensitivity and specificity were calculated to analyze the diagnostic character of the 3D-CAM-CN. Kappa coefficient was used to evaluate interrater reliability. Results: Two hundred forty-five adult patients were assessed for at least 2 days, resulting a total of 647 paired-assessments. When compared with the reference standard, the sensitivity and specificity of the 3D-CAM-CN assessment were 87.2 and 96.7%, respectively, by Role A and 84.6 and 97.4%, respectively, by Role B, with good interrater reliability (Kappa coefficient = 0.82, P < 0.001). It also performed well in patients with mild cognitive impairment, with the sensitivity from 85.7 to 100% and the specificity from 95.7 to 96.4%. Conclusion: Our results showed that the 3D-CAM-CN can be used as a reliable and accurate instrument for delirium assessment in surgical patients. Trial registration: This trail was approved by the Clinical Research Ethic Committee of Peking University First Hospital (No. 2017–1321) and registered on Chinese clinical trial registry on July 6, 2017 (ChiCTR-OOC-17011887). [ABSTRACT FROM AUTHOR]

Background: Current clinical guidelines recommend parent management training (PMT) in the treatment of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD). However, (a) a lack of supply and (b) structural barriers to attending and continuing face-to-face PMT restrict the access to this training. The main purpose of this study is to investigate the efficacy of online PMT in decreasing ADHD symptoms and oppositional behavior problems and to evaluate the effects of additional telephone-based support of the parents. Methods: The target sample size is n = 495 children with suspected or even clinical diagnosis of ADHD and current symptoms of ADHD or ODD. The study is based on a randomized three-arm parallel group design, in which the effects of treatment as usual (TAU) are compared to TAU plus web-assisted self-help (TAU+WASH) and to TAU plus web-assisted self-help and telephone-based support (TAU+WASH+SUPPORT). Discussion: The results will provide important insights into the efficacy of web-assisted self-help for parents of children with ADHD and the additional effects of telephone-based support. Trial registration: German Clinical Trials Register (DRKS) DRKS00013456. January 3rd 2018. World Health Organization Trial Registration Data Set: Universal Trial number (UTN) U1111–1205-6181. November 23rd 2017. [ABSTRACT FROM AUTHOR]

Background: The Paris and Nice terrorist attacks affected a thousand of trauma victims and first-line responders. Because there were concerns that this might represent the first of several attacks, there was a need to quickly enhance the local capacities to treat a large number of individuals suffering from trauma-related disorders. Since Reconsolidation Therapy (RT) is brief, relatively easy to learn, well tolerated and effective, it appeared as the ideal first-line treatment to teach to clinicians in this context. Methods: This study protocol is a two-arm non-randomized, multicenter controlled trial, comparing RT to treatment as usual for the treatment of trauma-related disorders. RT consists of actively recalling one's traumatic event under the influence of the ß-blocker propranolol, once a week, for 10–25 min with a therapist, over 6 consecutive weeks. This protocol evaluates the feasibility, effectiveness, and cost-utility of implementing RT as part of a large multi-center (N = 400) pragmatic trial with a one-year follow-up. Discussion: Paris MEM is the largest trial to date assessing the efficiency of RT in the aftermath of a large-scale man-made disaster. RT could possibly reinforce the therapeutic arsenal for the treatment of patients suffering from trauma-related disorders, not only for communities in western countries but also worldwide for terror- or disaster-stricken communities. Trial registration: Clinical Trials (ClinicalTrials.gov). June 3, 2016. NCT02789982. [ABSTRACT FROM AUTHOR]

Background: Worldwide, approximately 800,000 persons die by suicide every year; with rates of suicide attempts estimated to be much higher. Suicidal persons often suffer from a mental disorder but stigma, lack of available and suitable support, and insufficient information on mental health limit help seeking. The use of internet-based applications can help individuals inform themselves about mental disorders, assess the extent of their own concerns, find local treatment options, and prepare for contact with health care professionals. This project aims to develop and evaluate e-mental health interventions to improve knowledge about suicidality and to reduce stigmatization of those affected. In developing these interventions, a representative telephone survey was conducted to detect knowledge gaps and stigmatizing attitudes in the general population. Methods: First, a national representative telephone survey with N = 2000 participants in Germany was conducted. Second, e-mental health interventions are developed to address knowledge gaps and public stigma detected in the survey. These comprise an evidence-based health information package about suicidality, information on regional support services, a self-administered depression test—including suicidality—and an interactive online intervention including personal stories. The development is based on a trialogical exchange of experience between persons affected by suicidality, relatives of affected persons, and clinical experts. Australian researchers who developed an e-mental health intervention for individuals affected by rural suicide were invited to a workshop in order to contribute their knowledge and expertise. Third, the online intervention will be evaluated by a mixed methods design. Discussion: From representative telephone survey data, content can be developed to address specific attitudes and knowledge via the e-mental health interventions. These interventions will be easily accessed and provide an opportunity to reach people who tend not to seek professional services, prefer to inform themselves in advance and/or wish to remain anonymous. Evaluation of the online intervention will provide information on any changes in participants' self-stigma and perceived-stigma of suicidality, and any increase in participants' knowledge on suicidality or self-efficacy expectations. Trial registration: German Clinical Trial Register DRKS00015071 on August 6, 2018. [ABSTRACT FROM AUTHOR]

Background: Inpatients with depression have a poor long term outcome with high rates of suicide, high levels of morbidity and frequent re-admission. Current treatment often relies on pharmacological intervention and focuses on observation to maintain safety. There is significant neurocognitive deficit which is linked to poor functional outcomes. As a consequence, there is a need for novel psychotherapeutic interventions that seek to address these concerns. Methods: We combined cognitive activation and behavioural activation to create activation therapy (AT) for the treatment of inpatient depression and conducted a small open label study which demonstrated acceptability and feasibility. We propose a randomised controlled trial which will compare treatment as usual (TAU) with TAU plus activation therapy for adult inpatients with a major depressive episode. The behavioural activation component involves therapist guided re-engagement with previously or potentially rewarding activities. The cognitive activation aspect utilises computer based exercises which have been shown to improve cognitive function. Discussion: The proposed randomised controlled trial will examine whether or not the addition of this therapy to TAU will result in a reduced re-hospitalisation rate at 12 weeks post discharge. Subjective change in activation and objectively measured change in activity levels will be rated, and the extent of change to neurocognition will be assessed. Trial registration: Unique trial number: U1111–1190-9517. Australian New Zealand Clinical Trials Registry (ANZCTR) number: ACTRN12617000024347p. [ABSTRACT FROM AUTHOR]

Background: Several studies have shown the effectiveness of Metacognitive Therapy (MCT) in treating different mental disorders. Most of these studies were performed in English speaking countries using the original English version of the manual. Our study aimed to examine the feasibility of the translated MCT manual in a sample of German patients with major depressive disorder. Methods: Twenty outpatients (6 male, 14 female, mean age 42.1y) with major depressive disorder were included. The main outcome was drop-out rate and satisfaction with the treatment; secondary outcomes were changes in metacognitive beliefs assessed with the metacognitive questionnaire 30 (MCQ-30), and symptom reduction measured with the Beck Depression Inventory-2 sum score (BDI-2). Results: No drop-outs during the treatment and the follow-up phase were observed. Patients and therapists were highly satisfied with MCT treatment. The MCQ-30 significantly declined over the treatment course, paralleled by a significant reduction of the BDI-2 sum scores (from 29 ± 8.6 at T0 to 8.4 ± 9.6 at the end of treatment). The average treatment duration was 10 ± 4 sessions. Conclusions: Applying the German version of the manual for Metacognitive Therapy proved to be feasible in the treatment of depressed patients in an outpatient setting. The treatment was well tolerated by German patients. Outcome in terms of reduction of depressive symptoms was good. Remarkable is the comparably short treatment duration which should be investigated further in future studies. Trial registration: German Clinical Trials Register (DRKS): DRKS00023644, 17.11.2020 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Limitations of current therapy of depression highlight the need for an immediately available, easily implementable add-on treatment option with high acceptance from patients. Hyperthermic baths (HTB) are a form of balneotherapy with head-out-of-water-immersion in a hot pool or tub at 40 °C for 15–20 min. A prior study suggests that HTB added to usual depression care can have antidepressant effects. Method: Single-site, open-label randomised controlled 8-week parallel-group pilot study at a university outpatient clinic. 45 medically stable outpatients with moderate depression as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥ 18 and a score ≥ 2 on item 1 (Depressed Mood) were recruited. They were randomised to twice weekly HTB (n = 22) or a physical exercise program (PEP) of moderate intensity (n = 23). Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) and per-protocol (PP) principle. Results: Forty-five patients (HTB n = 22; PEP n = 23) were analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference after 2 weeks was 4.3 points in the HAM-D score in favor of HTB (p < 0.001). Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). Per protocol analysis only showed superiority of HTB as a trend (p = 0.068). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was higher than in other trials investigating exercise in depression. Due to the high number of dropouts the effect in the ITT-analysis may be overestimated. Conclusions: HTB added to usual care may be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depression severity after 2 weeks; it is also suitable for persons who have problems performing exercise training. Trial registration: German Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study. [ABSTRACT FROM AUTHOR]

Background: Recurrent and impairing functional somatic syndromes (FSS) are common in adolescents. Despite a high need for care, empirically supported treatments are lacking for youth. The aim of this uncontrolled pilot study was to assess feasibility and treatment potential of a new intervention with group-based Acceptance and Commitment Therapy (ACT) in a generic treatment approach for adolescents with multiple FSS. Methods: Twenty-one patients received 'ACT for Health in Adolescents' (AHEAD) (30 h), specifically developed for adolescents (aged 15–19 years) with moderate to severe FSS. Close relatives attended an information meeting to facilitate support of the patients throughout treatment. Treatment satisfaction was evaluated by means of self-report and relatives' impressions. Self-reported physical health at 3 months follow-up (FU) after end of treatment was the primary outcome whereas secondary outcomes included symptom burden, limitation due to symptoms, illness worry, emotional distress and physical and emotional symptoms. Treatment targets were assessed by measures on illness behaviour, illness perception and psychological inflexibility. Results: Nineteen patients (90.5%) completed the treatment with a high overall attendance rate of 93%. All would recommend the treatment to a friend with similar problems. Close relatives rated it valuable to participate in an information meeting. Patients' physical health improved significantly from assessment to FU with a clinically relevant mean change of 8.9 points (95% CI [5.4; 12.4]; SRM 0.91 [0.26;1.57]). Improvement was also seen on all secondary outcome measures, from assessment to FU. Maladaptive illness behaviours and perceptions as well as psychological inflexibility showed a significant decline from assessment to FU. Conclusion: AHEAD was feasible and potentially efficacious and warrants testing in a larger clinical trial. Trial registration: Clinical Trials gov NCT04464447, registration date July 9th, 2020. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Many patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one's treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA's potential efficacy in terms of improving quality of the decision-making process and quality of the decision made was also explored. Methods: The e-DA was based on International Patient Decision-Aid Standards and developed via an iterative co-design process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months' post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes). Results: Intervention participants endorsed the e-DA as acceptable and feasible to use (82.1–94.6% item agreement); most self-reported using the e-DA either selectively (51.8%; relevant sections only) or thoroughly (34%). Exploratory analyses indicated the e-DA's potential efficacy to improve decision-making quality; most between-group standardised mean differences (SMD) were small-to-moderate. The largest potential effects were detected for objective treatment knowledge (− 0.69, 95% CIs − 1.04, − 0.33 at T1; and − 0.57, 95% CIs − 0.99,-0.14 at T2), decisional regret at T2 (0.42, 95% CIs 0.01, 0.84), preparation for decision-making at T1 (− 0.44, 95% CIs − 0.81, − 0.07), and the Decisional Conflict Scale Uncertainty subscale (0.42, 95% CIs 0.08, 0.08) and Total (0.36, 95% CIs 0.30, 0.69) scores, with all SMDs favouring the Intervention over the Control conditions. Regarding safety, e-DA use was not associated with worse bipolar symptoms or anxiety. Conclusion: The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients' decision-making about BPII treatment. Findings also support the future adoption of the e-DA into patient care for BPII to foster treatment decisions based on the best available evidence and patient preferences. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12617000840381 (prospectively registered 07/06/2017). [ABSTRACT FROM AUTHOR]

Background: Farmers are a vulnerable population for developing depression or other mental health disorders due to a variety of risk factors in their work context. Beyond face-to-face resources, preventive internet- and tele-based interventions could extend available treatment options to overcome barriers to care. The German Social Insurance Company for Agriculture, Forestry and Horticulture (SVLFG) implements several guided internet- and mobile-based interventions and personalised tele-based coaching for this specific target group provided by external companies within a nation-wide prevention project for their insured members. The current study aims to evaluate the implementation process and to identify determinants of successful implementation on various individual and organisational levels. Methods: The current study includes two groups of participants: 1) insured persons with an observable need for prevention services, and 2) staff-participants who are involved in the implementation process. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR) will be used to track and evaluate the implementation process. A mixed-method approach will provide insights on individual and organizational level (e.g. degree of normalization, readiness for change) and helps to identify determinants of successful implementation. In-depth insights on experiences of the participants (e.g. acceptance, satisfaction, barriers and facilitating factors of intervention use) will be yielded through qualitative interviews. Focus groups with field workers provide insights into barriers and facilitators perceived during their consultations. Furthermore, intervention as well as implementation costs will be evaluated. According to the stepwise, national rollout, data collection will occur at baseline and continuously across 24 months. Discussion: The results will show to what extent the implementation of the internet- and tele-based services as a preventive offer will be accepted by the participants and involved employees and which critical implementation aspects will occur within the process. If the implementation of the internet- and tele-based services succeeds, these services may be feasible in the long-term. Trial registration: German Clinical Trial Registration: DRKS00017078. Registered on 18.04.2019. [ABSTRACT FROM AUTHOR]

Background: Schizophrenia patients with a metabolically abnormal obese (MAO) phenotype have been shown poor cardiovascular outcomes, but the characteristics of their current psychiatric symptoms have not been characterized. This study mainly explored the psychiatric symptoms of schizophrenia patients with the MAO phenotype. Methods: A total of 329 patients with schizophrenia and 175 sex- and age-matched people without schizophrenia from Anhui Province in China were enrolled. The Positive and Negative Syndrome Scale (PANSS) was used to evaluate the mental symptoms of the schizophrenia patients. The MAO phenotype was defined as meeting 1–4 metabolic syndrome criteria (excluding waist circumference) and having a body mass index (BMI) ≥ 28 kg/m2. And, metabolically healthy normal-weight (MHNW) phenotype was defined as meeting 0 criteria for metabolic syndrome and 18.5 ≤ BMI < 24 kg/m2. Results: Overall, 15.8% of the schizophrenia patients and 9.1% of the control group were consistent with the MAO phenotype, and the prevalence of MAO in the schizophrenia group was higher than that in the control group. Among the patients with schizophrenia, the MAO group had lower negative factor, cognitive factor and total PANSS scores than the MHNW group. However, when confounding factors were controlled, only the negative factor remained lower significantly. Conclusion: We found that schizophrenia patients with the MAO phenotype had reduced negative symptoms, which may indicate an internal mechanism linking metabolic disorders and negative symptoms. Trial registration: This study was registered in the China Clinical Trial Registration Center (No. chiCTR 1,800,017,044). [ABSTRACT FROM AUTHOR]

Background: We performed a follow up study about willingness and behaviors to quit smoking among smokers with schizophrenia in Japan. Methods: Participants were outpatients with schizophrenia aged 20–69 years who had been visiting the hospital for ≥1 year as of April 1, 2016, and had visited the hospital more than once in the previous 6 months. A baseline survey on smoking behaviors including current smoking status and smoking cessation stage, was administered in 420 participants that were randomly extracted from a patient pool (n = 680) in 2016, and a follow-up survey was administered in 2017. We calculated the distribution and change in smoking cessation stage, number of smokers and nonsmokers after 1 year, and quitting rate from a naturalistic 1-year smoking-cessation follow up. Results: The number of baseline respondents was 350; 113 current smokers and 68 former smokers. Among the 113 current smokers, 104 (92.0%) were followed for 1 year, 79 (70.0%) were interested in smoking cessation, and only 7 had received smoking cessation treatments at baseline. Among the tracked 104 participants, only 6 (5.8%) stopped smoking after 1 year. Among the 25 participants who had intentions to quit smoking within 6 months at baseline, 6 (24.0%) maintained their intention to quit smoking for 1 year, and 16 (64.0%) did not maintain their intention to quit smoking. Conclusions: Our findings showed that many smokers with schizophrenia were interested in quitting smoking, but few patients received treatment and actually quit smoking. Timely intervention, including the option to receive smoking cessation treatment, is necessary for those patients with schizophrenia who smoke. Trial registration: UMIN Clinical Trials Registry (UMIN000023874, registered on August 31, 2016). [ABSTRACT FROM AUTHOR]

Background: People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+). Methods: A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6–8 modules, duration: 6–8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach. Discussion: This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness. Trial registration: German Clinical Trial Registration: DRKS00014000. Registered on 09 April 2018. [ABSTRACT FROM AUTHOR]

Background: Antenatal depression is a prevalent mental disorder in women who have undergone caesarean section, and it often presages adverse postoperative outcomes. Because of the lack of a laboratory-based diagnostic strategy, antenatal depression is mainly determined by a psychologist's subjective judgment based on a structured clinical interview for established diagnostic criteria. However, the diagnostic accuracy rate for depression by non-psychiatrists is relatively low. Thus, this study aimed to use lipidomics to identify potential biomarkers related to antenatal depression in women who have undergone caesarean section. Methods: The study was designed as a matched prospective observational study. Singleton pregnant women scheduled to receive elective caesarean section, were screened for eligibility. Women diagnosed with major antenatal depression were matched with non-antenatal depression controls in terms of age (±1 year) and BMI (±1 kg/m2), and blood samples of the included matched pairs were collected. Subsequently, lipidomics of the plasma samples were performed using Ultra Performance Liquid Chromatography-mass spectrometry analysis to explore the differentially expressed lipids in women with or without antenatal depression. Results: In total, 484 pregnant women were screened; 66 subjects were recruited, including 33 subjects with major antenatal depression and 33 matched controls without antenatal depression. Thirty-five differentially expressed lipid metabolites were identified (P < 0.05). The area under the receiver operating characteristic curve of these lipid metabolites was 0.7 or larger; the area under curve for cholesterol sulfate was 0.823 (95% CI: 0.716–0.930), and that of PC (18:2 (2E, 4E)/0:0) was 0.778 (95%CI: 0.662–0.895). In the conditional logistic stepwise regression analysis, cholesterol sulfate (P = 0.009) and PC (18:2 (2E, 4E)/0:0) (P = 0.035) were also identified as effective predictive risk factors for antenatal depression. Conclusions: Women who had undergone caesarean section and experienced antenatal depression presented a significantly differentially expressed profile of plasma lipidomics compared to those who did not experience antenatal depression. Cholesterol sulfate and PC (18:2 (2E, 4E)/0:0) may be effective and specific lipidic biomarkers for the prediction of antenatal depression. Trial registration: China Clinical Trial Registration Center registration number: ChiCTR1800016230; date of registration: 21/05/2018. [ABSTRACT FROM AUTHOR]

Background: Construction workers are at elevated risk of suicide. MATES in Construction (MATES) is one of the few suicide prevention programs that explicitly address this problem. The MATES program includes an integrated system of services that supports prevention, early intervention and recovery (i.e., primary, secondary and tertiary prevention) for mental health problems among construction workers. In this protocol, we describe a proposed evaluation of MATESmobile, an electronic platform which will be accessed by workers who have undergone MATES training. Methods/design: In this protocol, we describe a Randomised Controlled Trial (RCT) which seeks to assess whether MATESmobile results in improved literacy regarding suicide prevention, and improved help-seeking and help-offering attitudes among those who have attended MATES training. Secondary outcomes include changes in suicide ideation, suicide attempt and psychological distress. Workers will be recruited prior to MATES face-to-face training. In total, 295 workers will be randomly assigned to the intervention condition (MATESmobile + face-to-face training) and 295 will be randomly allocated to the control (face-to-face training). The intervention will run for 8 weeks. Assessments will be run immediately post intervention, and at 3, 6, and 12 months Discussion: MATESmobile offers the potential to reinforce and enhance the effects of face-to-face training, resulting in greater skills and knowledge in suicide prevention, as well as a reduction in suicidality and distress. Trial registration: This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000625178; 26 April 2019). [ABSTRACT FROM AUTHOR]

Background: Syrians represent the largest group among refugees in Germany. Many of them were exposed to sequential traumatizing events including war, escape and post-migration stressors, which significantly increase the risk to develop symptoms of posttraumatic stress and other mental disorders. However, there is a lack of adequate treatment options for traumatized refugees in Germany. Moreover, their access to psychosocial care is often restricted due to legal regulation, language barriers, and unclear cost coverage. We therefore aim to develop a low-threshold supportive self-help app for Syrian refugees with posttraumatic stress symptoms. By conducting a randomized controlled trial, we further aim to evaluate the apps' efficacy, usability, acceptance, and economic health benefit/cost-effectiveness. Methods: We will develop a modular, interactive self-help app in Arabic, which will be grounded on cognitive-behavioral models for the treatment of posttraumatic stress. Subsequently, screened positive (i.e., Syrian refugees, 18–65 years old, mild to moderate posttraumatic stress symptomatology as quantified by the Posttraumatic Stress Diagnostic Scale for DSM-5/PDS-5) participants (ideally up to n = 234) will be randomly allocated to an intervention (IG) and control group (CG), respectively. Participants in the IG will gain access to the self-help app for one month, while participants in the CG will receive psychoeducational reading material in form of a comprehensive brochure on traumatization and posttraumatic stress. Measurements are scheduled before the intervention (T0), directly after the intervention (T1, one month later) and three months after the intervention (T2). Using linear mixed effect models, we will investigate change in posttraumatic symptomatology. We will also test for changes in secondary outcomes such as depression, anxiety, and quality of life. Moreover, we will inspect the usability and user acceptance of the app. To evaluate the app in terms of its economic health benefit, the incremental cost-effectiveness ratio will be calculated. Discussion: We plan to make the app freely available to the general public after evaluation. Thus, the app can help to add-on to routine care, which currently lacks sufficient and appropriate treatment options for Syrian refugees. Trial registration: German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS). Registration ID: DRKS00013782. Registered: 06th of July 2018. [ABSTRACT FROM AUTHOR]

Background: The treatment of major depressive disorder, a highly prevalent disorder associated with pronounced burden, is a large challenge to healthcare systems worldwide. Internet based self-management interventions seem to be a cost effective way to complement the treatment of depressed patients, but the accumulating evidence is mainly based on the comparison to waitlist controls and treatment as usual, which might lead to an overestimation of effects. Furthermore, studies assessing long-term effects and possible negative outcomes are still rare. Methods/Design: The proposed study evaluates the efficacy of the German version of the iFightDepression® tool in comparison to an active control condition. A total of 360 patients with mild to moderate depressive symptoms are included into a two-armed randomized controlled trial. They receive one of two six week interventions; either the iFightDepression® tool or progressive muscle relaxation serving as the control condition. Both intervention groups receive information material, weekly tasks via the internet and regular phone calls as part of the intervention. The primary outcome is change in depressive symptoms after the intervention period, as measured with the Inventory of Depressive Symptomatology. Satisfaction with the program, usability, changes in perceived quality of life, and possible negative effects are assessed as secondary outcomes. Discussion: This study represents the first randomized controlled trial on the iFightDepression® self-management tool in its German version, aiming at efficacy, but also at providing new insights into so far understudied aspects of E-mental health programs, namely the specificity of the treatment effect compared to an active control condition, it's continuity over a time course of 12 months, and possible negative effects of these internet based interventions. Trial registration: International trial-registration took place through the "international clinical trials registry platform" (WHO) with the secondary ID 080–15-09032015. German Clinical Trial Registration: DRKS00009323 (DRKS.de, registered on 25 February 2016). [ABSTRACT FROM AUTHOR]