ABSTRACT
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.
Subject(s)
Refugees , Stress Disorders, Post-Traumatic , Humans , Meta-Analysis as Topic , Middle East , Psychosocial Intervention , Randomized Controlled Trials as Topic , Refugees/psychology , Stress Disorders, Post-Traumatic/psychology , SyriaABSTRACT
Background: Syrian refugees in Switzerland face several barriers in accessing mental health care. Cost-effective psychological interventions are urgently needed to meet the mental health needs of refugees. Problem Management Plus (PM+) is an evidence-based, psychological intervention delivered by trained non-specialist 'helpers'. Objective: To assess the feasibility and acceptability of PM+ among Syrian refugees in Switzerland. Methods: We conducted a single-blind pilot randomized controlled trial (RCT) with Syrian refugees impaired by psychological distress (K10 > 15 and WHODAS 2.0 > 16). Participants were randomized to PM+ or Enhanced Treatment As Usual (ETAU). Participants were assessed at baseline, and 1 week and 3 months after the intervention, and completed measures indexing mental health problems and health care usage. Semi-structured interviews were conducted with different stakeholders. Results: N = 59 individuals were randomized into PM+ (n = 31) or ETAU (n = 28). N = 18 stakeholders were interviewed about facilitators and barriers for the implementation of PM+. Retention rates in the trial (67.8%) and mean intervention attendance (M = 3.94 sessions, SD = 1.97) were high. No severe events related to the study were reported. These findings indicate that the trial procedures and PM+ were feasible, acceptable and safe. Conclusions: The findings support the conduct of a definitive RCT and show that PM+ might have the potential to be scaled-up in Switzerland. The importance, as well as the challenges, of implementing and scaling-up PM+ in high-income countries, such as Switzerland, are discussed.
Antecedentes: Los refugiados Sirios en Suiza enfrentan varias barreras para acceder a la atención en salud mental. Se necesitan con urgencia intervenciones psicológicas costo-efectivas, para satisfacer las necesidades de salud mental de los refugiados. Enfrentar Problemas Plus (PM + por sus siglas en inglés) es una intervención psicológica basada en la evidencia proporcionada por 'ayudantes' capacitados no especializados.Objetivo: Evaluar la viabilidad y aceptabilidad de PM + entre los refugiados sirios en Suiza.Métodos: Realizamos un ensayo controlado aleatorizado (ECA) piloto simple y ciego con refugiados sirios afectados por angustia psicológica (K10 > 15 y WHODAS 2.0 > 16). Los participantes fueron asignados al azar a PM + o Tratamiento usual mejorado (TUM). Los participantes fueron evaluados al inicio del estudio, 1 semana, y 3 meses después de la intervención, y completaron instrumentos que referencian problemas de salud mental y el uso de la atención médica. Se realizaron entrevistas semiestructuradas con diferentes partes relevantes.Resultados:N = 59 individuos fueron asignados al azar a PM + (n = 31) o TUM (n = 28). N = 18 partes relevantes fueron entrevistados sobre facilitadores y barreras para la implementación de PM +. Las tasas de retención en el ensayo (67,8%) y la asistencia media a la intervención (M = 3,94 sesiones, DE = 1,97) fueron altas. No se informaron eventos graves relacionados con el estudio. Estos hallazgos indican que los procedimientos del ensayo y PM + fueron factibles, aceptables y seguros.Conclusiones: Los hallazgos apoyan la realización de un ECA definitivo y muestran que PM + podría tener el potencial de ampliarse en Suiza. Se discute la importancia, así como los desafíos, de implementar y ampliar PM + en países de altos ingresos, como Suiza.
