Impacts of the COVID-19 pandemic on access to healthcare among people with disabilities: evidence from six low- and middle-income countries.

BACKGROUND: The pandemic has placed considerable strain on health systems, especially in low- and middle-income countries (LMICs), leading to reductions in the availability of routine health services. Emerging evidence suggests that people with disabilities have encountered marked challenges in accessing healthcare services and supports in the context of the pandemic. Further research is needed to explore specific barriers to accessing healthcare during the pandemic, and any strategies that promoted continued access to health services in LMICs where the vast majority of people with disabilities live. METHODS: Qualitative in-depth interviews were conducted with persons with disabilities in Ghana, Zimbabwe, Viet Nam, Türkiye (Syrian refugees), Bangladesh, and India as part of a larger project exploring the experiences of people with disabilities during the COVID-19 pandemic and their inclusion in government response activities. Data were analysed using thematic analysis. RESULTS: This research found that people with disabilities in six countries - representing a diverse geographic spread, with different health systems and COVID-19 responses - all experienced additional difficulties accessing healthcare during the pandemic. Key barriers to accessing healthcare during the pandemic included changes in availability of services due to systems restructuring, difficulty affording care due to the economic impacts of the pandemic, fear of contracting coronavirus, and a lack of human support to enable care-seeking. CONCLUSION: These barriers ultimately led to decreased utilisation of services which, in turn, negatively impacted their health and wellbeing. However, we also found that certain factors, including active and engaged Organisations of Persons with Disabilities (OPDs) and Non-Governmental Organizations (NGOs) played a role in reducing some of the impact of pandemic-related healthcare access barriers.

Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial.

INTRODUCTION: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress. OBJECTIVE: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe. METHODS: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes. RESULTS: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52-1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29-0.87). CONCLUSIONS: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

Problems after flight: understanding and comparing Syrians' perspectives in the Middle East and Europe.

BACKGROUND: Syrian refugees and asylum seekers (SRAs) face multiple stressors after flight, which may vary due to different geographic, economic, cultural and socio-political contexts in the host countries. Past research has recognised the importance of participants' own perspectives. The aims of this multi-country study were to identify and compare self-reported problems of SRAs between various settings. METHODS: A semi-structured client-generated outcome measurement was used to collect data among adult SRAs in Jordan (N = 61), Turkey (N = 46) and Switzerland (N = 57) between September 2018 and November 2019. Answers were analysed following thematic analysis. RESULTS: Over half of the participants reported practical problems with an emphasis on camp-related problems (Jordan), finances (Turkey), employment (Jordan and Switzerland) and government regulations (Switzerland), followed by psychological, and social issues. CONCLUSION: This study highlights the impact of local contextual factors on wellbeing. The findings emphasise that planning preventative procedures and mental health care services for SRAs need to consider local challenges affecting the population in specific countries.

Prevalence and predictors of common mental disorders among Syrian refugees in Istanbul, Turkey: a cross-sectional study.

PURPOSE: The war in Syria has created the greatest refugee crisis in the twenty-first century. Turkey hosts the highest number of registered Syrian refugees, who are at increased risk of common mental disorders because of their exposure to war, violence and post-displacement stressors. The aim of this paper is to examine the prevalence and predictors of anxiety, depression, and post-traumatic stress disorder (PTSD) symptoms among Syrian refugees living in Turkey. METHODS: A cross-sectional survey of adult Syrian refugees was conducted between February and May 2018 in Istanbul (Sultanbeyli district). Participants (N = 1678) were randomly selected through the registration system of the district municipality. The Hopkins Symptoms Checklist (HSCL-25) was used to measure anxiety and depression and the Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5) assessed posttraumatic stress. Descriptive and multivariate regression analyses were used. RESULTS: The prevalence of symptoms of anxiety, depression and PTSD were 36.1%, 34.7% and 19.6%, respectively. Comorbidity was high. Regression analyses identified several socio-demographic, health and post-displacement variables that predicted common mental disorders including: being female, facing economic difficulties, previous trauma experience, and unmet need for social support, safety, law and justice. A lifetime history of mental health treatment and problems accessing adequate healthcare were associated with depression and anxiety but not with PTSD. CONCLUSIONS: Mental disorder symptoms are highly prevalent among Syrian refugees in Turkey. The association with post-displacement factors points to the importance of comprehensive health and social services that can address these social, economic and cultural stressors.

Socio-cultural integration of Afghan refugees in Türkiye: the role of traumatic events, post-displacement stressors and mental health.

AIMS: Socio-cultural integration of refugees has received scant attention in the academic literature. Türkiye hosts the largest number of refugees, including Afghans, as the second largest asylum-seeking group in Türkiye. There is a dearth of research into the mental health and integration of Afghan refugees in Türkiye. The aim of the present study was to investigate socio-cultural integration outcomes among Afghan refugees in Türkiye by considering the role of traumatic events and post-displacement stressors. The role of mental health in integration outcomes was further examined. METHODS: A cross-sectional, web-based survey study with 785 Afghan refugees in Türkiye was conducted between April and June 2021. Data were collected on socio-demographic characteristics, potentially traumatic events (PTEs) (Harvard Trauma Questionnaire), post-displacement stressors (Post-Migration Living Difficulties Checklist), mental health symptoms (Hopkins Symptoms Checklist-25), social integration- social bonds (contact with co-ethnic group members) and social bridges (contact with the host community)- and cultural integration (Vancouver Index of Acculturation). Structural equation modelling was conducted to test the hypothesized relationship between conflict and displacement-related stressors, mental health and socio-cultural integration. RESULTS: Findings showed that conflict-related traumatic events and post-displacement stressors significantly predicted higher mental health symptoms. Experiencing traumatic events significantly predicted higher levels of social bridges, adopting destination culture and lower level of maintaining heritage culture. Mental health problems predicted the relationship between stressors related to forced displacement and integration outcomes-social bridges and adopting destination culture. These findings highlight the role of mental health as an indispensable resource for socio-cultural integration. Further, conflict and displacement-related stressors are important determinants of socio-cultural integration among Afghan refugees in Türkiye. CONCLUSION: Exposure to PTEs and post-displacement stressors were significant risk factors for the mental health and socio-cultural integration of Afghan refugees in Türkiye. These stressful experiences deteriorate refugees' mental health, which hinders their integration into the host society.

Estimated prevalence rates and risk factors for common mental health problems among Syrian and Afghan refugees in Türkiye.

BACKGROUND: Türkiye hosts 4 million refugees and asylum seekers, with Syrians and Afghans being among the largest refugee groups in country. There are limited comparative data on the conflict- and displacement-related experiences of these groups and the relation with mental health status. AIMS: To assess the mental health status of Syrians and Afghans in Türkiye, identify risk factors and explore to what extent differences in mental health conditions are related to potentially traumatic events and post-displacement stressors. METHOD: Two parallel online survey studies were conducted between April and June 2021 among 798 Syrians and 785 Afghans in Türkiye. Data were collected on sociodemographic characteristics, traumatic events (Harvard Trauma Questionnaire), post-displacement stressors (Post-Migration Living Difficulties Checklist), symptoms of depression and anxiety (Hopkins Symptoms Checklist-25) and post-traumatic stress disorder (PTSD) (Post-Traumatic Stress Disorder Checklist for DSM-5, short form). RESULTS: For Syrian and Afghan participants respectively, estimated prevalence rates were: 41.1% and 50.3% for depression; 39.6% and 41% for anxiety; and 41.6% and 46.5% for PTSD. In both groups, significant predictors were female gender, exposure to potentially traumatic events, and structural and socioeconomic post-displacement stressors. Additional risk factors were older age for Afghans and higher education for Syrians. CONCLUSIONS: Self-reported symptoms of common mental health problems are highly prevalent among Syrian and Afghan refugees and associated with a wide range of risk factors. After controlling for conflict- and displacement-related experiences, Afghans reported higher anxiety symptoms than Syrians, which is likely related to their legal status in Türkiye.

Cost-effectiveness of the Self-Help Plus Intervention for Adult Syrian Refugees Hosted in Turkey.

Importance: The cost-effectiveness of the Self-Help Plus (SH+) program, a group-based, guided, self-help psychological intervention developed by the World Health Organization for people affected by adversity, is unclear. Objective: To investigate the cost-utility of providing the SH+ intervention combined with enhanced usual care vs enhanced usual care alone for Syrian refugees or asylum seekers hosted in Turkey. Design, Setting, and Participants: This economic evaluation was performed as a prespecified part of an assessor-blinded randomized clinical trial conducted between October 1, 2018, and November 30, 2019, with 6-month follow-up. A total of 627 adults with psychological distress but no diagnosed psychiatric disorder were randomly assigned to the intervention group or the enhanced usual care group. Interventions: The SH+ program was a 5-session (2 hours each), group-based, stress management course in which participants learned self-help skills for managing stress by listening to audio sessions. The SH+ sessions were facilitated by briefly trained, nonspecialist individuals, and an illustrated book was provided to group members. Th intervention group received the SH+ intervention plus enhanced usual care; the control group received only enhanced usual care from the local health care system. Enhanced usual care included access to free health care services provided by primary and secondary institutions plus details on nongovernmental organizations and freely available mental health services, social services, and community networks for people under temporary protection of Turkey and refugees. Main Outcomes and Measures: The primary outcome measure was incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the Turkish health care system. An intention-to-treat analysis was used including all participants who were randomized and for whom baseline data on costs and QALYs were available. Data were analyzed September 30, 2020, to July 30, 2021. Results: Of 627 participants (mean [SD] age, 31.3 [9.0] years; 393 [62.9%] women), 313 were included in the analysis for the SH+ group and 314 in the analysis for the enhanced usual care group. An incremental cost-utility ratio estimate of T£6068 ($1147) per QALY gained was found when the SH+ intervention was provided to groups of 10 Syrian refugees. At a willingness to pay per QALY gained of T£14 831 ($2802), the SH+ intervention had a 97.5% chance of being cost-effective compared with enhanced usual care alone. Conclusions and Relevance: This economic evaluation suggests that implementation of the SH+ intervention compared with enhanced usual care alone for adult Syrian refugees or asylum seekers hosted in Turkey is cost-effective from the perspective of the Turkish health care system when both international and country-specific willingness-to-pay thresholds were applied.

Effectiveness of a WHO self-help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial.

Refugees are at high risk of developing mental disorders. There is no evidence from randomized controlled trials (RCTs) that psychological interventions can prevent the onset of mental disorders in this group. We assessed the effectiveness of a self-help psychological intervention developed by the World Health Organization, called Self-Help Plus, in preventing the development of mental disorders among Syrian refugees experiencing psychological distress in Turkey. A two-arm, assessor-masked RCT was conducted in two Turkish areas. Eligible participants were adult Syrian refugees experiencing psychological distress (General Health Questionnaire ≥3), but without a diagnosis of mental disorder. They were randomly assigned either to the Self-Help Plus arm (consisting of Self-Help Plus combined with Enhanced Care as Usual, ECAU) or to ECAU only in a 1:1 ratio. Self-Help Plus was delivered in a group format by two facilitators over five sessions. The primary outcome measure was the presence of any mental disorder assessed by the Mini International Neuropsychiatric Interview at six-month follow-up. Secondary outcome measures were the presence of mental disorders at post-intervention, and psychological distress, symptoms of post-traumatic stress disorder and depression, personally identified psychological outcomes, functional impairment, subjective well-being, and quality of life at post-intervention and six-month follow-up. Between October 1, 2018 and November 30, 2019, 1,186 refugees were assessed for inclusion. Five hundred forty-four people were ineligible, and 642 participants were enrolled and randomly assigned to either Self-Help Plus (N=322) or ECAU (N=320). Self-Help Plus participants were significantly less likely to have any mental disorders at six-month follow-up compared to the ECAU group (21.69% vs. 40.73%; Cramer's V = 0.205, p<0.001, risk ratio: 0.533, 95% CI: 0.408-0.696). Analysis of secondary outcomes suggested that Self-Help Plus was not effective immediately post-intervention, but was associated with beneficial effects at six-month follow-up in terms of symptoms of depression, personally identified psychological outcomes, and quality of life. This is the first prevention RCT ever conducted among refugees experiencing psychological distress but without a mental disorder. Self-Help Plus was found to be an effective strategy for preventing the onset of mental disorders. Based on these findings, this low-intensity self-help psychological intervention could be scaled up as a public health strategy to prevent mental disorders in refugee populations exposed to ongoing adversities.

Trajectories of psychosocial symptoms and wellbeing in asylum seekers and refugees exposed to traumatic events and resettled in Western Europe, Turkey, and Uganda.

Background: Longitudinal studies examining mental health trajectories in refugees and asylum seekers are scarce. Objectives: To investigate trajectories of psychological symptoms and wellbeing in refugees and asylum seekers, and identify factors associated with these trajectories. Method: 912 asylum seekers and refugees from the control arm of three trials in Europe (n = 229), Turkey (n = 320), and Uganda (n = 363) were included. We described trajectories of psychological symptoms and wellbeing, and used trauma exposure, age, marital status, education, and individual trial as predictors. Then, we assessed the bidirectional interactions between wellbeing and psychological symptoms, and the effect of each predictor on each outcome controlling for baseline values. Results: Symptom improvement was identified in all trials, and for wellbeing in 64.7% of participants in Europe and Turkey, versus 31.5% in Uganda. In Europe and Turkey domestic violence predicted increased symptoms at post-intervention (ß = 1.36, 95% CI 0.17-2.56), whilst murder of family members at 6-month follow-up (ß = 1.23, 95% CI 0.27-2.19). Lower wellbeing was predicted by murder of family member (ß = -1.69, 95% CI -3.06 to -0.32), having been kidnapped (ß = -1.67, 95% CI -3.19 to -0.15), close to death (ß = -1.38, 95% CI -2.70 to -0.06), and being in the host country ≥2 years (ß = -1.60, 95% CI -3.05 to -0.14). In Uganda at post-intervention, having been kidnapped predicted increased symptoms (ß = 2.11, 95% CI 0.58-3.65), and lack of shelter (ß = -2.51, 95% CI -4.44 to -0.58) and domestic violence predicted lower wellbeing (ß = -1.36, 95% CI -2.67 to -0.05). Conclusion: Many participants adapt to adversity, but contextual factors play a critical role in determining mental health trajectories.

Antecedentes: Estudios longitudinales que examinan las trayectorias de la salud mental en los refugiados y solicitantes de asilo son escasos.Objetivos: Investigar las trayectorias de los síntomas psicológicos y el bienestar en refugiados y solicitantes de asilo, e identificar factores asociados a estas trayectorias.Métodos: Se incluyeron 912 solicitantes de asilos y refugiados del brazo control de tres ensayos clínicos en Europa (n = 229), Turquía (n = 320) y Uganda (n = 363). Describimos las trayectorias psicológicas de los síntomas y el bienestar, y utilizamos la exposición traumática, la edad, el estado marital, la educación y el juicio individual como predictores. Después, evaluamos las interacciones bidireccionales entre el bienestar y los síntomas psicológicos, y el efecto de cada uno de los predictores en cada resultado controlando por los valores iniciales.Resultados: Se identificó una mejoría en los síntomas en todos los ensayos, y del bienestar en el 64.7% de los participantes en Europa y Turquía, versus el 31.5% en Uganda. En Europa y en Turquía, la violencia doméstica predijo el incremento de síntomas de después de la intervención (ß = 1.36, 95% CI 0.17 a 2.56), mientras que el homicidio de algún miembro familiar a los 6 meses de seguimiento (ß = 1.23, 95% CI 0.27 a 2.19). Un menor bienestar fue predicho por el homicidio de algún miembro de la familia (ß = −1.69, 95% CI −3.06 a −0.32), haber sido secuestrado (ß = −1.67, 95% CI −3.19 a −0.15), haber estado próximo a la muerte (ß = −1.38, 95% CI −2.70 a −0.06), y estar en el país de acogida ≥2 años (ß = −1.60, 95% CI −3.05 a −0.14). En Uganda, después de la intervención, haber sido secuestrado predijo un aumento de los síntomas (ß =2.11, 95% CI 0.58 a 3.65), y la falta de refugio (ß = −2.51, 95% CI −4.44 a −0.58) y la violencia doméstica predijo un menor bienestar (ß = −1.36, 95% CI −2.67 a −0.05).Conclusión: Muchos participantes se adaptan a la adversidad, pero los factores contextuales juegan un papel crítico en determinar las trayectorias de la salud mental.

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.

Post-traumatic growth and its predictors among Syrian refugees in Istanbul: A mental health population survey.

AIMS: The negative mental health effects of exposure to trauma are well-documented. However, some individuals are theorized to undergo post-traumatic growth (PTG) after exposure to trauma, potentially experiencing positive psychological change across five domains: appreciation for life, relationships with others, new possibilities in life, personal strength, and spiritual change. PTG is less studied in forcibly displaced populations in low- and middle-income countries. This study aimed to explore levels of PTG and associated factors among Syrian refugee adults living in Istanbul, Turkey. METHODS: A cross-sectional survey was conducted with 1678 respondents. This study analyzed PTG data from 768 individuals as measured by the Post-Traumatic Growth Inventory (PTGI). Descriptive analysis and univariate and multivariate least squares linear regression modeling were used. Factor analysis and Cronbach's alpha tests assessed the psychometric properties of the PTGI. RESULTS: The sample exhibited a moderate level of PTG at 55.94 (SD=22.91, range 0-105). Factor analysis of PTGI revealed only four factors instead of five, and the PTGI yielded high internal reliability (Cronbach's α=0.90). PTG and post-traumatic stress disorder (PTSD) had a curvilinear relationship, with the highest PTG levels experienced by those with moderate PTSD levels. Five other variables were significantly associated with PTG: older age, less education, somatic distress, and history of an overnight stay at a health facility for mental health care were associated with lower PTG, while more years of education were associated with higher PTG. CONCLUSIONS: This study identified the role of the sociodemographic and psychological determinants that influence post-traumatic growth among Syrian refugees in Istanbul. These findings could be used to inform future research and programs seeking to understand PTG in refugees.

Pathways towards scaling up Problem Management Plus in Turkey: a theory of change workshop.

BACKGROUND: A considerable evidence base has been produced in recent years highlighting the effectiveness of brief scalable psychological interventions for people living in communities exposed to adversity. However, practical guidance on how to scale up these interventions to wider populations does not exist. In this paper we report on the use of Theory of Change (ToC) to plan the scale up of the World Health Organization's flagship low intensity psychological intervention "Problem Management Plus" (PM+) for Syrian refugees in Turkey. METHODS: We conducted a one-day ToC workshop in Istanbul. ToC is a participatory planning process used in the development, implementation and evaluation of projects. It is similar to driver diagrams or logic models in that it offers a tool to visually present the components needed to reach a desired long-term outcome or impact. The overall aim of ToC is to understand the change process of a complex intervention and to map out causal pathways through which an intervention or strategy has an effect. RESULTS: Twenty-four stakeholders (including governmental officials, mental health providers, officials from international/national non-governmental organisations, conflict and health researchers) participated in the ToC workshop. A ToC map was produced identifying three key elements of scaling up (the resource team; the innovation and the health system; and the user organisation) which are represented in three distinct causal pathways. Context-specific barriers related to the health system and the political environment were identified, and possible strategies for overcoming these challenges were suggested. CONCLUSION: ToC is a valuable methodology to develop an integrated framework for scaling up. The results highlight that the scaling up of PM+ for Syrian refugees in Turkey needs careful planning and investment from different stakeholders at the national level. Our paper provides a theoretical foundation of the scaling up of PM+, and exemplifies for the first time the use of ToC in planning the scaling up of an evidence-based psychological intervention in global mental health.

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey.

BACKGROUND: A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, and breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post-migration living difficulties such as discrimination or integration problems or both. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. METHODS: A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring above 16 on the WHO Disability Assessment Schedule 2.0, or WHODAS 2.0) will be randomly assigned to Group PM+/enhanced care as usual (Group PM+/E-CAU) (n = 190) or E-CAU (n = 190). Outcome assessments will take place 1 week after the fifth session (post-assessment), 3 months after the fifth session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, post-traumatic stress symptoms, self-identified problems, and health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants, including participants, facilitators, policy makers and mental health professionals. DISCUSSION: The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of Group PM+ have been established. TRIAL REGISTRATION: Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03960892. Unique protocol ID: 10/2017. Prospectively registered on 21 May 2019.

Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials.

INTRODUCTION: This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey. METHODS AND ANALYSIS: Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness. ETHICS AND DISSEMINATION: The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings. TRIALS REGISTRATION NUMBERS: NCT03571347, NCT03587896.