Twelve-month follow-up of a randomised clinical trial of a brief group psychological intervention for common mental disorders in Syrian refugees in Jordan.

AIMS: There is increasing evidence that brief psychological interventions delivered by lay providers can reduce common mental disorders in the short-term. This study evaluates the longer-term impact of a brief, lay provider delivered group psychological intervention (Group Problem Management Plus; gPM+) on the mental health of refugees and their children's mental health. METHODS: This single-blind, parallel, controlled trial randomised 410 adult Syrians in Azraq Refugee Camp in Jordan who screened positive for distress and impaired functioning to either five sessions of gPM+ or enhanced usual care (EUC). Primary outcomes were scores on the Hopkins Symptom Checklist-25 (HSCL-25; depression and anxiety scales) assessed at baseline, 6 weeks, 3 months and 12 months Secondary outcomes included disability, posttraumatic stress, personally identified problems, prolonged grief, prodromal psychotic symptoms, parenting behaviour and children's mental health. RESULTS: Between 15 October 2019 and 2 March 2020, 204 participants were assigned to gPM + and 206 to EUC, and 307 (74.9%) were retained at 12 months. Intent-to-treat analyses indicated that although participants in gPM + had greater reductions in depression at 3 months, at 12 months there were no significant differences between treatment arms on depression (mean difference -0.9, 95% CI -3.2 to 1.3; p = 0.39) or anxiety (mean difference -1.7, 95% CI -4.8 to -1.3; p = 0.06). There were no significant differences between conditions for secondary outcomes except that participants in gPM + had greater increases in positive parenting. CONCLUSIONS: The short-term benefits of a brief, psychological programme delivered by lay providers may not be sustained over longer time periods, and there is a need for sustainable programmes that can prolong benefits gained through gPM + .

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.

Effectiveness of a brief group behavioral intervention for common mental disorders in Syrian refugees in Jordan: A randomized controlled trial.

BACKGROUND: Common mental disorders are frequently experienced by refugees. This study evaluates the impact of a brief, lay provider delivered group-based psychological intervention [Group Problem Management Plus (gPM+)] on the mental health of refugees in a camp, as well as on parenting behavior and children's mental health. METHODS AND FINDINGS: In this single-blind, parallel, randomized controlled trial, 410 adult Syrian refugees (300 females, 110 males) in Azraq Refugee Camp (Jordan) were identified through screening of psychological distress (≥16 on the Kessler Psychological Distress Scale) and impaired functioning (≥17 on the WHO Disability Assessment Schedule). Participants were randomly allocated to gPM+ or enhanced usual care (EUC) involving referral information for psychosocial services on a 1:1 ratio. Participants were aware of treatment allocation, but assessors were blinded to treatment condition. Primary outcomes were scores on the Hopkins Symptom Checklist-25 (HSCL; depression and anxiety scales) assessed at baseline, 6 weeks, and 3 months follow-up as the primary outcome time point. It was hypothesized that gPM+ would result in greater reductions of scores on the HSCL than EUC. Secondary outcomes were disability, posttraumatic stress, personally identified problems, prolonged grief, prodromal psychotic symptoms, parenting behavior, and children's mental health. Between October 15, 2019 and March 2, 2020, 624 refugees were screened for eligibility, 462 (74.0%) screened positive, of whom 204 were assigned to gPM+ and 206 to EUC. There were 168 (82.4%) participants in gPM+ and 189 (91.7%) in EUC assessed at follow-up. Intent-to-treat analyses indicated that at follow-up, participants in gPM+ showed greater reduction on HSCL depression scale than those receiving EUC (mean difference, 3.69 [95% CI 1.90 to 5.48], p = .001; effect size, 0.40). There was no difference between conditions in anxiety (mean difference -0.56, 95% CI -2.09 to 0.96; p = .47; effect size, -0.03). Relative to EUC, participants in gPM+ had greater reductions in severity of personally identified problems (mean difference 0.88, 95% CI 0.07 to 1.69; p = .03), and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < .001). There were no significant differences between conditions for changes in PTSD, disability, grief, prodromal symptoms, or childhood mental health outcomes. Mediation analysis indicated the change in inconsistent disciplinary parenting was associated with reduced attentional (ß = 0.11, SE .07; 95% CI .003 to .274) and internalizing (ß = 0.08, SE .05; 95% CI .003 to 0.19) problems in children. No adverse events were attributable to the interventions or the trial. Major limitations included only one-quarter of participants being male, and measures of personally identified problems, grief, prodromal psychotic symptoms, inconsistent parenting behavior, and children's mental health have not been validated with Syrians. CONCLUSIONS: In camp-based Syrian refugees, a brief group behavioral intervention led to reduced depressive symptoms, personally identified problems, and disciplinary parenting compared to usual care, and this may have indirect benefits for refugees' children. The limited capacity of the intervention to reduce PTSD, disability, or children's psychological problems points to the need for development of more effective treatments for refugees in camp settings. TRIAL REGISTRATION: Prospectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619001386123.

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.

Group problem management plus (gPM+) in the treatment of common mental disorders in Syrian refugees in a Jordanian camp: study protocol for a randomized controlled trial.

BACKGROUND: Accessing quality mental health care poses significant challenges for persons affected by adversity, especially in low- and middle-income countries where resources are scarce. To mitigate this, the World Health Organization has developed group problem management plus (gPM+), a low-intensity psychological intervention for adults experiencing psychological distress. gPM+ is a group-based intervention consisting of five-sessions, and can be delivered by non-specialist providers. This paper outlines the study protocol for a trial of gPM+ in Jordan. METHODS: We will conduct a single-blind, two-arm, randomized controlled trial in a Syrian refugee camp in Jordan. We aim to enrol 480 adults into the trial. Participants will be eligible for the trial if they screen positive for levels of psychological distress. Following screening, those eligible will be randomly assigned to receive the gPM+ intervention or enhanced treatment as usual. The primary outcome is reduction in levels of psychological distress at 3-months post-treatment. Secondary outcomes include anxiety, depression, prodromal psychotic symptoms, posttraumatic stress disorder, prolonged grief, daily functioning, economic effectiveness, and change in parenting behaviour. Secondary outcomes also include the reduction in psychological distress of the participant's child. DISCUSSION: The trial aims to deliver a template for affordable and scalable psychosocial interventions that can readily be implemented in refugee settings, and that can benefit both the participant and their child. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001386123. Registered prospectively on 10/10/2019.