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.

Feasibility trial of a scalable transdiagnostic group psychological intervention for Syrians residing in a refugee camp.

Background: Approximately 10% of Syrian refugees currently reside in camp settings, which can impose additional post-migration stressors. With elevated rates of psychological distress and few available resources, task-shifting psychosocial programmes are necessary to provide adequate care. One such programme developed by the World Health Organization (WHO) is Group Problem Management Plus (GroupPM+). Objective: This study aimed to test the safety and acceptability of GroupPM+ in a refugee camp and to identify areas for adaptation in preparation for a definitive RCT. Method: A feasibility randomized controlled trial (RCT) was conducted in Azraq refugee camp in Jordan. Inclusion criteria were: (1) Syrian adults aged ≥18 years, (2) parent of a child aged 10-16 years, (3) experiencing psychological distress as defined by a score of ≥16 on the Kessler Distress Scale, and (4) ≥17 on the WHO Disability Assessment Schedule 2.0. Following baseline assessments, participants were randomized to receive GroupPM+ or enhanced treatment-as-usual. Post-assessments were conducted one week following the last GroupPM+ session. Primary outcomes were feasibility and acceptance of GroupPM+; symptoms of anxiety, depression, PTSD, prodromal psychosis, grief, and child's self-reported psychological distress were also assessed. Results: Of the 207 persons screened, 64 (31%) screened positive for psychological distress. Of the 35 randomized into the GroupPM+ intervention, 24 (69%) completed the intervention. No adverse events were reported throughout the trial. Children whose parents received GroupPM+ had greater reductions in internalizing and externalizing symptoms at posttreatment. 55 (86%) participants completed the post-assessment follow-up. These results demonstrate both the feasibility of conducting the trial in a camp and acceptance of the GroupPM+ intervention by Syrian refugees. Conclusions: Following the feasibility trial, both the implementation procedures and intervention were safe and culturally acceptable. The results support the readiness for a definitive RCT to determine the effectiveness and cost-effectiveness of the intervention in camp settings.

Antecedentes: Aproximadamente el 10% de refugiados sirios reside actualmente en campos de refugiados, lo que puede imponer estresores adicionales después de la migración. Con tasas elevadas de angustia psicológica y pocos recursos disponibles, los programas psicosociales de rotación de tareas son necesarios para brindar un cuidado adecuado. Uno de estos programas, desarrollado por la Organización Mundial de la Salud (OMS), es el Programa Grupal para el Manejo de Problemas Plus ('Group Problem Management Plus', o GroupPM+).Objetivos: Este estudio tuvo como objetivo el probar la seguridad y la aceptabilidad del GroupPM+ en un campo de refugiados e identificar las áreas de adaptación en preparación para un ensayo clínico controlado y aleatorizado (ECA).Métodos: Se llevó a cabo un ensayo clínico controlado y aleatorizado (ECA) de viabilidad en el campo de refugiados de Azraq en Jordania. Los criterios de inclusión fueron (1) ser un adulto sirios con una edad ≥ 18 años, (2) ser padre de un niño de 10 a 16 años, (3) experimentar angustia psicológica, definida mediante un puntaje ≥ 16 en la Escala de Malestar Psicológico de Kessler, y (4) un puntaje ≥ 17 en el Cuestionario para la Evaluación de la Discapacidad 2.0 de la OMS. Después de las evaluaciones iniciales, los participantes fueron distribuidos aleatoriamente para recibir la intervención mediante el GroupPM+ o para recibir el tratamiento usual optimizado. Las evaluaciones posteriores fueron conducidas una semana después de la última sesión del GroupPM+. Los resultados principales fueron la viabilidad y la aceptación del GroupPM+; los síntomas de ansiedad, de depresión, del trastorno de estrés postraumático (TEPT), la psicosis prodrómica, el duelo, y también se evaluó el auto-reporte de la angustia psicológica por parte del niño.Resultados: De las 207 personas evaluadas, 64 (31%) dieron positivo en presentar angustia psicológica. De las 35 personas incluidas de manera aleatoria en el grupo de intervención mediante el GroupPM+, 24 (69%) completaron la intervención. No se reportaron eventos adversos durante el ensayo clínico. Los niños cuyos padres recibieron la intervención mediante el GroupPM+ tuvieron una mayor reducción en los síntomas internalizantes y externalizantes después del tratamiento. 55 (86%) participantes completaron el seguimiento posterior a la evaluación. Estos resultados demuestran tanto la viabilidad de conducir el ensayo clínico en un campo de refugiados, como la aceptación de la intervención mediante el GroupPM+ por parte de los refugiados sirios.Conclusiones: De acuerdo con el ensayo de viabilidad, tanto los procedimientos de implementación como la intervención fueron seguros y culturalmente aceptables. Los resultados apoyan la preparación para un ECA definitivo para determinar la efectividad y costo-efectividad de la intervención en los campos de refugiados.