A WHO digital intervention to address depression among young Chinese adults: a type 1 effectiveness-implementation randomized controlled trial.

Common mental disorders among young people are rising globally. Current university-based interventions are inadequate to address the need for evidence-based interventions. We investigated the effectiveness and implementation of Step-by-Step (SbS), a WHO digital intervention to address depression, among Chinese university students with depressive symptoms. In this paper, we report a type 1 hybrid effectiveness-implementation randomized controlled trial conducted between September 2021 and September 2022. The control condition was enhanced treatment as usual (ETAU, psychoeducation). The primary outcome was improvement in depression symptoms. Secondary outcomes were improvements in psychological well-being, anxiety symptoms, and self-identified psychosocial problems. Effectiveness of the intervention was evaluated using generalized linear mixed models. Implementation outcomes were evaluated by thematic analysis of participant interviews. A total of 371 participants were enrolled to two treatment conditions in a 1:1 ratio. SbS resulted in a greater reduction in depressive symptoms at posttreatment (p = 0.004, Hedges' g = 0.35), but no significant difference between SbS and ETAU was observed at three-month follow-up (p = 0.179, Hedges' g = 0.16). The treatment effect was larger among those who adhered to the treatment (Hedges' gs = 0.59 and 0.30). Subjective well-being also improved for SbS at both time points (Hedges' gs = 0.31 and 0.30). In addition, SbS resulted in more improvement in anxiety symptoms at posttreatment (p = 0.029, Hedges' g = 0.26), but not at three-month follow-up (p = 0.265, Hedges' g = 0.13). The qualitative results demonstrated that the intervention was well-implemented as a self-help mental health service, with minimal support from peer supporters. In conclusion, Step-by-Step, a digital intervention developed by WHO, was effective in reducing depressive symptoms in the short term and improving psychological well-being in a longer term. The sustained effect on depression needs further investigation. Improving uptake and engagement in the program is needed for its scale-up implementation as a university-based mental health service for Chinese young adults. Trial registration: ChiCTR2100050214.

Internet-based transdiagnostic treatment for emotional disorders in Arabic- and Farsi-speaking refugees: study protocol of a randomized controlled trial.

BACKGROUND: Refugee populations have an increased risk for mental disorders, such as depression, anxiety, and posttraumatic stress disorders. Comorbidity is common. At the same time, refugees face multiple barriers to accessing mental health treatment. Only a minority of them receive adequate help. The planned trial evaluates a low-threshold, transdiagnostic Internet-based treatment. The trial aims at establishing its efficacy and cost-effectiveness compared with no treatment. METHODS: N = 131 treatment-seeking Arabic- or Farsi-speaking patients, meeting diagnostic criteria for a depressive, anxiety, and/or posttraumatic stress disorder will be randomized to either the intervention or the waitlist control group. The intervention group receives an Internet-based treatment with weekly written guidance provided by Arabic- or Farsi-speaking professionals. The treatment is based on the Common Elements Treatment Approach (CETA), is tailored to the individual patient, and takes 6-16 weeks. The control group will wait for 3 months and then receive the Internet-based treatment. DISCUSSION: The planned trial will result in an estimate of the efficacy of a low-threshold and scalable treatment option for the most common mental disorders in refugees. TRIAL REGISTRATION: German Registry for Clinical Trials DRKS00024154. Registered on February 1, 2021.

Blended-ALMAMAR app for inpatient mental health care for refugees: study protocol for a multicenter implementation study within the I-REACH consortium (Internet based REfugee mentAl healtH Care).

BACKGROUND: Refugees are at high risk for developing mental illnesses. Due to language and cultural barriers, there is need for specifically adapted therapeutic procedures for refugees in inpatient mental health care settings. Internet-based applications in refugee mother tongues have the potential to improve the outcomes of mental health care for this vulnerable population. The key research question of the present implementation study is whether the newly developed "blended ALMAMAR" app for Arabic and Farsi speaking refugees in Germany is used and accepted by patients and professionals in routine inpatient mental health care (blended care). METHODS: We present the design of an observational, prospective multicenter implementation study in eight psychiatric hospitals. We plan to recruit 100 Farsi or Arabic speaking refugees receiving in-patient treatment due to depression, anxiety disorder, posttraumatic stress disorder or substance use disorders. These patients will get access to the "blended ALMAMAR" app during their inpatient stay in a blended-care approach. We will assess the usage (e.g., duration and frequency of use of the app) as well as subjective acceptability and usability of the intervention. To identify sociodemographic and clinical factors associated with "blended ALMAMAR" usage, we will also perform clinical and questionnaire assessments. DISCUSSION: The newly developed "blended ALMAMAR" app may help to close communication gaps for the hard-to reach and vulnerable group of refugees in inpatient mental health care. It is the first blended-care intervention that addresses severely mentally ill refugees in an inpatient psychiatric setting in Germany. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Register on November 11, 2021 (DRKS00025972) and adapted on November 14, 2023.

Understanding the protective effect of social support on depression symptomatology from a longitudinal network perspective.

BACKGROUND: Higher social support protects people from developing mental disorders. Limited evidence is available on the mechanism through which social support plays this protective role. OBJECTIVE: To investigate the stress-buffering process of social support on depressive symptoms using a novel longitudinal dynamic symptom network approach. METHODS: A total of 4242 adult participants who completed the first two waves (from May to October 2020) of the International Covid Mental Health Survey were included in the study. Cross-lagged panel network modelling was used to estimate a longitudinal network of self-reported social support, loneliness and depressive symptoms. Standardised regression coefficients from regularised cross-lagged regressions were estimated as edge weights of the network. FINDINGS: The results support a unidirectional protective effect of social support on key depressive symptoms, partly mediated through loneliness: A higher number of close confidants and accessible practical help was associated with decreased anhedonia (weight=-0.033) and negative self-appraisal symptoms (weight=-0.038). Support from others was also negatively associated with loneliness, which in turn associated with decreased depressed mood (weight=0.086) and negative self-appraisal (weight=0.077). We identified a greater number of direct relationships from social support to depressive symptoms among men compared with women. Also, the edge weights from social support to depression were generally stronger in the men's network. CONCLUSIONS: Reductions in negative self-appraisal might function as a bridge between social support and other depressive symptoms, and, thus, it may have amplified the protective effect of social support. Men appear to benefit more from social support than women. CLINICAL IMPLICATIONS: Building community-based support networks to deliver practical support, and loneliness reduction components are critical for depression prevention interventions after stressful experiences.

Effects of a Self-Guided Transdiagnostic Smartphone App on Patient Empowerment and Mental Health: Randomized Controlled Trial.

BACKGROUND: Mental disorders impact both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in chronification. Besides limited health care resources, within-person barriers such as the lack of trust in professionals, the fear of stigmatization, or the desire to cope with problems without professional help contribute to the treatment gap. Self-guided mental health apps may support treatment seeking by reducing within-person barriers and facilitating mental health literacy. Digital mental health interventions may also improve mental health related self-management skills and contribute to symptom reduction and the improvement of quality of life. OBJECTIVE: This study aims to investigate the effects of a self-guided transdiagnostic app for mental health on help seeking, reduced stigma, mental health literacy, self-management skills, mental health symptoms, and quality of life using a randomized controlled design. METHODS: Overall, 1045 participants (recruited via open, blinded, and web-based recruitment) with mild to moderate depression or anxiety-, sleep-, eating-, or somatization-related psychopathology were randomized to receive either access to a self-guided transdiagnostic mental health app (MindDoc) in addition to care as usual or care as usual only. The core features of the app were regular self-monitoring, automated feedback, and psychological courses and exercises. The coprimary outcomes were mental health literacy, mental health-related patient empowerment and self-management skills (MHPSS), attitudes toward help seeking, and actual mental health service use. The secondary outcomes were psychopathological symptom burden and quality of life. Data were collected at baseline and 8 weeks and 6 months after randomization. Treatment effects were investigated using analyses of covariance, including baseline variables as predictors and applying multiple imputation. RESULTS: We found small but robust between-group effects for MHPSS (Cohen d=0.29), symptoms burden (Cohen d=0.28), and quality of life (Cohen d=0.19) 8 weeks after randomization. The effects on MHPSS were maintained at follow-up. Follow-up assessments also showed robust effects on mental health literacy and preliminary evidence for the improvement of help seeking. Predictors of attrition were lower age and higher personality dysfunction. Among the non-attritors, predictors for deterioration were less outpatient treatment and higher initial symptom severity. CONCLUSIONS: A self-guided transdiagnostic mental health app can contribute to lasting improvements in patient empowerment. Symptoms of common mental disorders and quality of life improved faster in the intervention group than in the control group. Therefore, such interventions may support individuals with symptoms of 1 or more internalizing disorders, develop health-centered coping skills, prevent chronification, and accelerate symptom improvement. Although the effects for individual users are small and predictors of attrition and deterioration need to be investigated further, the potential public health impact of a self-guided intervention can be large, given its high scalability. TRIAL REGISTRATION: German Clinical Trials Register DRKS00022531; https://drks.de/search/de/trial/DRKS00022531.

Mental health across two years of the COVID-19 pandemic: a 5-wave longitudinal study in Germany.

The COVID-19 pandemic has been negatively associated with mental health. However, little is known about the temporal dynamics of mental health in the longer term of the pandemic. We aimed to investigate symptom levels and changes of depression, anxiety, posttraumatic stress, and loneliness spanning two years of the pandemic; and to examine associated risk factors. This five-wave, longitudinal online study from May 2020 to April 2022 included 636 adults (Mage = 39.5 years, SD = 16.11; 84.1% female) from the German general population who completed the international COVID-19 Mental Health Survey. Symptoms of anxiety (Generalized Anxiety Disorder-7; GAD-7), depression (Patient Health Questionnaire-9; PHQ-9), posttraumatic stress (PTSD Checklist for DSM-5; PCL-5), and loneliness ("Do you feel lonely?") were assessed using mixed-effects models. Associations with anxiety and depressive symptoms were examined with having children, student status, financial worries, contamination fear, and loneliness. PHQ-9, GAD-7, PCL-5, and loneliness scores overall decreased throughout the two-year period of the pandemic but exhibited an increase during two national lockdowns. Controlled for significant associations with female gender and younger age, increased PHQ-9 and GAD-7 scores were associated with contamination fear, financial worries, and loneliness. No associations were found with having children and student status. Symptoms of depression, anxiety, posttraumatic stress, and loneliness decreased over time but varied along with the dynamics of the pandemic. Longitudinal monitoring of mental health in vulnerable subgroups is required, especially those of younger age, females, and the financially insecure.

Correction: Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1004025.].

Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus.

BACKGROUND: The mental health burden among refugees in high-income countries (HICs) is high, whereas access to mental healthcare can be limited. OBJECTIVE: To examine the effectiveness of a peer-provided psychological intervention (Problem Management Plus; PM+) in reducing symptoms of common mental disorders (CMDs) among Syrian refugees in the Netherlands. METHODS: We conducted a single-blind, randomised controlled trial among adult Syrian refugees recruited in March 2019-December 2021 (No. NTR7552). Individuals with psychological distress (Kessler Psychological Distress Scale (K10) >15) and functional impairment (WHO Disability Assessment Schedule (WHODAS 2.0) >16) were allocated to PM+ in addition to care as usual (PM+/CAU) or CAU only. Participants were reassessed at 1-week and 3-month follow-up. Primary outcome was depression/anxiety combined (Hopkins Symptom Checklist; HSCL-25) at 3-month follow-up. Secondary outcomes included depression (HSCL-25), anxiety (HSCL-25), post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; PCL-5), impairment (WHODAS 2.0) and self-identified problems (PSYCHLOPS; Psychological Outcomes Profiles). Primary analysis was intention-to-treat. FINDINGS: Participants (n=206; mean age=37 years, 62% men) were randomised into PM+/CAU (n=103) or CAU (n=103). At 3-month follow-up, PM+/CAU had greater reductions on depression/anxiety relative to CAU (mean difference -0.25; 95% CI -0.385 to -0.122; p=0.0001, Cohen's d=0.41). PM+/CAU also showed greater reductions on depression (p=0.0002, Cohen's d=0.42), anxiety (p=0.001, Cohen's d=0.27), PTSD symptoms (p=0.0005, Cohen's d=0.39) and self-identified problems (p=0.03, Cohen's d=0.26), but not on impairment (p=0.084, Cohen's d=0.21). CONCLUSIONS: PM+ effectively reduces symptoms of CMDs among Syrian refugees. A strength was high retention at follow-up. Generalisability is limited by predominantly including refugees with a resident permit. CLINICAL IMPLICATIONS: Peer-provided psychological interventions should be considered for scale-up in HICs.

A protocol for a type 1 effectiveness-implementation randomized controlled trial of the WHO digital mental health intervention Step-by-Step to address depression among Chinese young adults in Macao (SAR), China.

Background: Among Chinese college students, the burden of depression is considerably high, affecting up to 30 % of the population. Despite this burden, few Chinese students seek mental health treatment. In addition, depression is highly comorbid with other mental health disorders, such as anxiety. Scalable, transdiagnostic, evidence-based interventions are needed for this population. Objective: The study will evaluate the effectiveness of a World Health Organization transdiagnostic digital mental health intervention, Step-by-Step, to reduce depressive and anxiety symptoms and improve well-being compared with enhanced care as usual and its implementation in a Chinese university community. Methods: A type 1 effectiveness-implementation two-arm, parallel, randomized controlled trial will be conducted. The two conditions are 1) the 5-session Step-by-Step program with minimal guidance by trained peer-helpers and 2) psychoeducational information on depression and anxiety and referrals to local community services. A total of 334 Chinese university students will be randomized with a 1:1 ratio to either of the two groups. Depression, anxiety, wellbeing, and client defined problems will be assessed at pre-intervention, post-intervention, and 3-month follow-up. Endline qualitative interviews and focus group discussions will be conducted to explore SbS implementation among service users, university staff, and stakeholders. Data will be analysed based on the intent-to-treat principle. Discussion: Step-by-Step is an innovative approach to address common mental health problems in populations with sufficient digital literacy. It is a promising intervention that can be embedded to scale mental health services within a university setting. It is anticipated that after successful evaluation of the program and its implementation in the type 1 hybrid design RCT study, Step-by-Step can be scaled and maintained as a low-intensity treatment in universities, and potentially extended to other populations within the Chinese community. Trial registration: ChiCTR2100050214.

Resilience of people with chronic medical conditions during the COVID-19 pandemic: a 1-year longitudinal prospective survey.

BACKGROUNDS: Individuals with chronic medical conditions are considered highly exposed to COVID-19 pandemic stress, but emerging evidence is demonstrating that resilience is common even among them. We aimed at identifying sustained resilient outcomes and their predictors in chronically ill people during the first year of the pandemic. METHODS: This international 4-wave 1-year longitudinal online survey included items on socio-demographic characteristics, economic and living situation, lifestyle and habits, pandemic-related issues, and history of mental disorders. Adherence to and approval of imposed restrictions, trust in governments and in scientific community during the pandemic were also investigated. The following tools were administered: the Patient Health Questionnaire, the Generalized Anxiety Disorder scale, the PTSD Checklist DSM-5, the Oslo Social Support Scale, the Padua Inventory, and the Portrait Values Questionnaire. RESULTS: One thousand fifty-two individuals reporting a chronic condition out of 8011 total participants from 13 countries were included in the study, and 965 had data available for the final model. The estimated probability of being "sustained-resilient" was 34%. Older male individuals, participants employed before and during the pandemic or with perceived social support were more likely to belong to the sustained-resilience group. Loneliness, a previous mental disorder, high hedonism, fear of COVID-19 contamination, concern for the health of loved ones, and non-approving pandemic restrictions were predictors of not-resilient outcomes in our sample. CONCLUSIONS: We found similarities and differences from established predictors of resilience and identified some new ones specific to pandemics. Further investigation is warranted and could inform the design of resilience-building interventions in people with chronic diseases.

Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.

BACKGROUND: Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon. METHODS AND FINDINGS: We conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate. CONCLUSIONS: In this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720769.

Evaluating the Implementation of a Mental Health App for Overseas Filipino Workers in Macao China: A Mixed-Methods Study of Stakeholders' Perspectives.

Background: Overseas Filipino workers (OFWs) is one of the largest communities of international migrant workers. They face systemic barriers to fulfilling their health needs. The COVID-19 pandemic worsened this condition and provided a context to evaluate the utility of a digital mental health intervention delivered within a stepped-care model to address OFW mental health. Using an implementation science framework, this study aimed to evaluate stakeholders' perspectives on the implementation of Kumusta Kabayan, a mobile phone-based mental health app, for OFWs in Macao. Methods: A mixed-methods convergent design was used by conducting two parallel steps, including quantitative and qualitative measures. The quantitative data was collected from Filipino team members and local non-governmental organization (NGO) staff members (N = 12). The qualitative data were gathered from interviews with OFWs in Macao who used the app (N = 25; 80% females, 76% domestic workers). Results: From the online survey, the staff members of the local partner NGO and the Filipino team members strongly perceived that their organization could adapt Kumusta Kabayan to their program and generally evaluated that Kumusta Kabayan achieved its goal and was received well by OFWs. In the interviews, the OFW app users shared their experiences in using Kumusta Kabayan, which was thematically organized into six aspects of the participants' experience: (1) promotional channel and expectation; (2) when to use the app and in what language; (3) lessons learnt; (4) memorable aspects; (5) key facilitators and barriers; and (6) suggestions. Conclusion: Kumusta Kabayan was well accepted and shows potential to be integrated into the existing support services for OFWs in Macao. This app has the promise of being scaled-up for OFWs in other countries by collaborating with local and overseas stakeholders. Lessons learnt from this evaluation could also be implemented in wider digital mental health services in different settings.

Symptoms of anxiety and depression during the COVID-19 pandemic in six European countries and Australia - Differences by prior mental disorders and migration status.

BACKGROUND: Little is known about changes of mental health during the COVID-19 pandemic in potentially disadvantaged groups. We investigated changes in anxiety and depression symptoms during the first year of the pandemic in six European countries and Australia by prior mental disorders and migration status. METHODS: Overall, 4674 adults answered a web-based survey in May-June 2020 and were followed by three repeated surveys up to February 2021. Information on psychosocial, financial and demographic, living conditions, prior mental disorders, depression and anxiety symptoms during the pandemic and migration status was collected. Weighted general estimation equations modelling was used to investigate the association between prior mental disorders, migration status, and symptoms over time. RESULTS: Most participants were <40 years old (48%), women (78%) and highly educated (62%). The baseline prevalence of depressive and anxiety symptoms ranged between 19%-45% and 13%-35%, respectively. In most countries, prevalence rates remained unchanged throughout the pandemic and were higher among people with prior mental disorders than without even after adjustment for several factors. We observed interactions between previous mental disorders and symptoms of anxiety or depression over time in two countries. No difference by migration status was noted. LIMITATIONS: Convenience sampling limits generalizability. Self-assessed symptoms of depression and anxiety might involve some misclassification. CONCLUSIONS: Depression and anxiety symptoms were worse among individuals with prior mental disorders than without, but there was no clear trend of worsening mental health in the observed groups during the observed period.

Guided digital health intervention for depression in Lebanon: randomised trial.

BACKGROUND: Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic. OBJECTIVE: To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring economic, humanitarian and political crises, a large industrial disaster and the COVID-19 pandemic. METHODS: We conducted a single-blind, two-arm pragmatic randomised trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among people suffering from depression and impaired functioning. Primary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)) and impaired functioning (WHO Disability Assessment Schedule-12 (WHODAS)) at post-treatment. FINDINGS: 680 people with depression (PHQ-9>10) and impaired functioning (WHODAS>16) were randomised to Step-by-Step or ECAU. Intention-to-treat analyses showed effects on depression (standardised mean differences, SMD: 0.71; 95% CI: 0.45 to 0.97), impaired functioning (SMD: 0.43; 95% CI: 0.21 to 0.65), post-traumatic stress (SMD: 0.53; 95% CI: 0.27 to 0.79), anxiety (SMD: 0.74; 95% CI: 0.49 to 0.99), subjective well-being (SMD: 0.37; 95% CI: 0.12 to 0.62) and self-identified personal problems (SMD: 0.56; 95% CI 0.29 to 0.83). Significant effects on all outcomes were retained at 3-month follow-up. CONCLUSIONS: Guided digital mental health interventions can be effective in the treatment of depression in communities exposed to adversities in LMICs, although some uncertainty remains because of high attrition. CLINICAL IMPLICATIONS: Guided digital mental health interventions should be considered for implementation in LMICs. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03720769.

Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis.

INTRODUCTION: The World Health Organization's (WHO) scalable psychological interventions, such as Problem Management Plus (PM+) and Step-by-Step (SbS) are designed to be cost-effective non-specialist delivered interventions to reduce symptoms of common mental disorders, such as anxiety, depression and post-traumatic stress disorder (PTSD). The STRENGTHS consortium aims to evaluate the effectiveness, cost-effectiveness and implementation of the individual format of PM+ and its group version (gPM+), as well as of the digital SbS intervention among Syrian refugees in seven countries in Europe and the Middle East. This is a study protocol for a prospective individual participant data (IPD) meta-analysis to evaluate (1) overall effectiveness and cost-effectiveness and (2) treatment moderators of PM+, gPM+ and SbS with Syrian refugees. METHODS AND ANALYSIS: Five pilot randomised controlled trials (RCTs) and seven fully powered RCTs conducted within STRENGTHS will be combined into one IPD meta-analytic dataset. The RCTs include Syrian refugees of 18 years and above with elevated psychological distress (Kessler Psychological Distress Scale (K10>15)) and impaired daily functioning (WHO Disability Assessment Schedule 2.0 (WHODAS 2.0>16)). Participants are randomised into the intervention or care as usual control group, and complete follow-up assessments at 1-week, 3-month and 12-month follow-up. Primary outcomes are symptoms of depression and anxiety (25-item Hopkins Symptom Checklist). Secondary outcomes include daily functioning (WHODAS 2.0), PTSD symptoms (PTSD Checklist for DSM-5) and self-identified problems (PSYCHLOPS). We will conduct a one-stage IPD meta-analysis using linear mixed models. Quality of evidence will be assessed using the GRADE approach, and the economic evaluation approach will be assessed using the CHEC-list. ETHICS AND DISSEMINATION: Local ethical approval has been obtained for each RCT. This IPD meta-analysis does not require ethical approval. The results of this study will be published in international peer-reviewed journals.

Trauma-related but not PTSD-related increases in hair cortisol concentrations in military personnel.

Dysregulated hypothalamic-pituitary-adrenal (HPA) axis functioning has been associated with posttraumatic stress disorder (PTSD). The current literature is inconsistent regarding this association, possibly due to confounding influences. Hair cortisol concentrations (HCC) allow for retrospective assessment of cumulative HPA axis secretion over several weeks and are considered a trait-like marker of HPA axis activity. Three groups of active and former German Armed Forces service members, comprising PTSD patients (n = 19), healthy controls with deployment-related trauma exposure (n = 10), and non-deployed healthy controls (n = 10) provided samples for HCC analysis. We observed significantly higher HCC in the PTSD and the deployed compared to the non-deployed group. HCC was neither significantly correlated with perceived chronic stress, nor with PTSD severity within patients. The results suggest a differential impact of trauma exposure on HPA axis activity and highlight the notion of cumulative, retrospective cortisol secretion as a psychobiological indicator of trauma exposure. TRIAL REGISTRATION: Australian Clinical Trials Registry (ACTRN12616000956404).

Attentional bias in German Armed Forces veterans with and without posttraumatic stress symptoms - An eye-tracking investigation and group comparison.

BACKGROUND AND OBJECTIVES: Most eye tracking based paradigms evidence patterns of sustained attention on threat coupled with low evidence for vigilance to or avoidance of threat in posttraumatic stress symptoms (PTSS). Still, eye tracking data on attention bias is particularly limited for military population. This eye tracking study investigated attentional bias in PTSS in a sample of German Armed Forces veterans. METHODS: Veterans with deployment-related PTSS (N = 24), veterans with deployment-related traumatization without PTSS (N = 28), and never-deployed healthy veterans (N = 18) were presented with pairs of combat and neutral pictures, pairs of general threat and neutral pictures, and pairs of emotional and neutral faces. Their eye gazes were tracked during a free viewing task. 3 x 3 x 2 mixed general linear model analyses were conducted. Internal consistency of attention bias indicators was calculated for the entire sample and within groups. RESULTS: Veterans with PTSS dwelled longer on general threat AOIs in contrast to non-exposed controls and shorter on general threat and combat associated neutral AOIs in contrast to both control groups. Veterans with PTSS entered faster to general threat AOIs than non-exposed controls. Veterans with PTSS showed circumscribed higher attention fluctuation in contrast to controls. Internal consistency varied across attention bias indicators. LIMITATIONS: Statistical power was reduced due to recruitment difficulties. CONCLUSIONS: Evidence is provided for the maintenance hypothesis in PTSS. No robust evidence is provided for hypervigilant behavior in PTSS. Findings on attention bias variability remain unclear, calling for more investigations in this field.

Salivary Cortisol and Alpha-Amylase in Posttraumatic Stress Disorder and Their Potential Role in the Evaluation of Cognitive Behavioral Treatment Outcomes.

Alterations in HPA-axis and autonomic nervous system activity have been associated with posttraumatic stress disorder (PTSD) development and maintenance and are potentially associated with trauma-focused cognitive behavioral therapy (TF-CBT) outcomes. We examined the role of salivary cortisol (sCort) and alpha-amylase (sAA) in PTSD and TF-CBT outcomes in German Armed Forces service members (N = 100). Participants categorized as PTSD patients (n = 39), previously deployed healthy controls (n = 33), and nondeployed healthy controls (n = 28) provided diurnal profiles of sCort and sAA; PTSD patients provided samples before, immediately after, and 3 months after an internet-based TF-CBT intervention. No group differences emerged regarding total daily sCort and sAA output or daily slopes, ps = .224-.897, fs = 0.05-0.24. Participants with PTSD demonstrated a significantly attenuated sCort awakening response compared to deployed, p = .021, d = 0.59, but not nondeployed controls, p = .918, d = 0.08. Moreover, a significantly steeper sAA awakening response emerged in PTSD patients, p = .034, d = 0.67, and deployed controls, p = .014, d = 0.80, compared to nondeployed controls. From pretreatment to posttreatment (n = 21) and posttreatment to follow-up (n = 14), stable sCort, ps = .282-.628, fs = 0.34-0.49, and sAA concentrations, ps = .068-.758, fs = 0.24-1.13 paralleled a nonsignificant treatment effect. Both PTSD and trauma exposure were associated with alterations in awakening responses, but further investigation is needed to determine whether the observed correspondence remains when PTSD symptoms significantly decline.

Does app-based unguided self-management improve mental health literacy, patient empowerment and access to care for people with mental health impairments? Study protocol for a randomised controlled trial.

INTRODUCTION: Mental disorders pose a huge burden to both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in comorbidity and chronification. Besides limited resources in healthcare systems, the treatment-gap is-to a large extent-caused by within-person barriers impeding early treatment seeking. These barriers include a lack of trust in professionals, fear of stigmatisation, or the desire to cope with problems without professional help. While unguided self-management interventions are not designed to replace psychotherapy, they may support early symptom assessment and recognition by reducing within-person barriers. Digital self-management solutions may also reduce inequalities in access to care due to external factors such as regional unavailability of services. METHODS AND ANALYSIS: Approximately 1100 patients suffering from mild to moderate depressive, anxiety, sleep, eating or somatisation-related mental disorders will be randomised to receive either a low-threshold unguided digital self-management tool in the form of a transdiagnostic mental health app or care as usual. The primary outcomes will be mental health literacy, patient empowerment and access to care while secondary outcomes will be symptom distress and quality of life. Additional moderator and predictor variables are negative life events, personality functioning, client satisfaction, mental healthcare service use and application of self-management strategies. Data will be collected at baseline as well as 8 weeks and 6 months after randomisation. Data will be analysed using multiple imputation and analysis of covariance employing the intention-to-treat principle, while sensitivity analyses will be based on different multiple imputation parameters and a per-protocol analysis. ETHICS AND DISSEMINATION: Approval was obtained from the Ethics Committee of the Faculty of Educational Science and Psychology at the Freie Universität Berlin. The results will be submitted to peer-reviewed specialised journals and presented at national and international conferences. TRIAL REGISTERATION: The trial has been registered in the DRKS trial register (DRKS00022531);Pre-results.

Associations between oxytocin and vasopressin concentrations, traumatic event exposure and posttraumatic stress disorder symptoms: group comparisons, correlations, and courses during an internet-based cognitive-behavioural treatment.

Background: Posttraumatic stress disorder (PTSD) is characterized by impairments in extinction learning and social behaviour, which are targeted by trauma-focused cognitive behavioural treatment (TF-CBT). The biological underpinnings of TF-CBT can be better understood by adding biomarkers to the clinical evaluation of interventions. Due to their involvement in social functioning and fear processing, oxytocin and arginine vasopressin might be informative biomarkers for TF-CBT, but to date, this has never been tested. Objective: To differentiate the impact of traumatic event exposure and PTSD symptoms on blood oxytocin and vasopressin concentrations. Further, to describe courses of PTSD symptoms, oxytocin and vasopressin during an internet-based TF-CBT and explore interactions between these parameters. Method: We compared oxytocin and vasopressin between three groups of active and former male service members of the German Armed Forces (n = 100): PTSD patients (n = 39), deployed healthy controls who experienced a deployment-related traumatic event (n = 33) and non-deployed healthy controls who never experienced a traumatic event (n = 28). PTSD patients underwent a 5-week internet-based TF-CBT. We correlated PTSD symptoms with oxytocin and vasopressin before treatment onset. Further, we analysed courses of PTSD symptoms, oxytocin and vasopressin from pre- to post-treatment and 3 months follow-up, as well as interactions between the three parameters. Results: Oxytocin and vasopressin did not differ between the groups and were unrelated to PTSD symptoms. PTSD symptoms were highly stable over time, whereas the endocrine parameters were not, and they also did not change in mean. Oxytocin and vasopressin were not associated with PTSD symptoms longitudinally. Conclusions: Mainly due to their insufficient intraindividual stability, single measurements of endogenous oxytocin and vasopressin concentrations are not informative biomarkers for TF-CBT. We discuss how the stability of these biomarkers might be increased and how they could be better related to the specific impairments targeted by TF-CBT.

Antecedentes: El trastorno de estrés postraumático (TEPT) se caracteriza por deficiencias en el aprendizaje de extinción y el comportamiento social, que son el objetivo del tratamiento cognitivo conductual centrado en el trauma (TF-CBT). Los fundamentos biológicos de TF-CBT se pueden entender mejor agregando biomarcadores a la evaluación clínica de las intervenciones. Debido a su participación en el funcionamiento social y el procesamiento del miedo, la oxitocina y la arginina vasopresina podrían ser biomarcadores informativos para la TF-CBT, pero hasta la fecha, esto nunca se ha probado.Objetivo: Diferenciar el impacto de la exposición a un evento traumático y los síntomas del TEPT en las concentraciones de oxitocina y vasopresina en la sangre. Además, para describir la evolución de los síntomas del TEPT, la oxitocina y la vasopresina durante una TF-CBT basada en Internet y explorar las interacciones entre estos parámetros.Método: Comparamos la oxitocina y la vasopresina entre tres grupos de militares activos y ex militares de las Fuerzas Armadas Alemanas (n = 100): pacientes con TEPT (n = 39), controles sanos desplegados que experimentaron un evento traumático relacionado con el despliegue (n = 33) y controles sanos no desplegados que nunca experimentaron un evento traumático (n = 28). Los pacientes con TEPT se sometieron a una TF-CBT basada en Internet durante 5 semanas. Correlacionamos los síntomas del TEPT con la oxitocina y la vasopresina antes del inicio del tratamiento. Además, analizamos la evolución de los síntomas del TEPT, la oxitocina y la vasopresina antes y después del tratamiento y el seguimiento de 3 meses, así como las interacciones entre los tres parámetros.Resultados: La oxitocina y la vasopresina no difirieron entre los grupos y no se relacionaron con los síntomas del TEPT. Los síntomas del TEPT fueron muy estables en el tiempo, mientras que los parámetros endocrinos no lo fueron, y tampoco cambiaron en la media. La oxitocina y la vasopresina no se asociaron con los síntomas del TEPT de forma longitudinal.Conclusiones: Principalmente debido a su estabilidad intraindividual insuficiente, las mediciones únicas de las concentraciones de oxitocina y vasopresina endógenas no son biomarcadores informativos para TF-CBT. Discutimos cómo podría aumentarse la estabilidad de estos biomarcadores y cómo podrían relacionarse mejor con las deficiencias específicas a las que se dirige TF-CBT.