Community based sociotherapy for depressive symptomatology of Congolese refugees in Rwanda and Uganda (CoSTAR): a protocol for a cluster randomised controlled trial

ABSTRACT

Background: Conflict in the Democratic Republic of Congo has led to large numbers of refugees fleeing to Uganda and Rwanda. Refugees experience elevated levels of adverse events and daily stressors, which are associated with common mental health difficulties such as depression. The current cluster randomised controlled trial aims to investigate whether an adapted form of Community-based Sociotherapy (aCBS) is effective and cost-effective in reducing depressive symptomatology experienced by Congolese refugees in Uganda and Rwanda.

Methods: A two-arm, single-blind cluster randomised controlled trial (cRCT) will be conducted in Kyangwali settlement, Uganda and Gihembe camp, Rwanda. Sixty-four clusters will be recruited and randomly assigned to either aCBS or Enhanced Care As Usual (ECAU). aCBS, a 15-session group-based intervention, will be facilitated by two people drawn from the refugee communities. The primary outcome measure will be self-reported levels of depressive symptomatology (PHQ-9) at 18-weeks post-randomisation. Secondary outcomes will include levels of mental health difficulties, subjective wellbeing, post-displacement stress, perceived social support, social capital, quality of life, and PTSD symptoms at 18-week and 32-week post-randomisation. Cost effectiveness of aCBS will be measured in terms of health care costs (cost per Disability Adjusted Life Year, DALY) compared to ECAU. A process evaluation will be undertaken to investigate the implementation of aCBS.

Conclusion: This cRCT will be the first investigating aCBS for mental health difficulties experienced by refugees and will contribute to knowledge about the use of psychosocial interventions for refugees at a time when levels of forced migration are at a record high.

Trial registration: ISRCTN.org identifier: ISRCTN20474555.

HIGHLIGHTS

• There is a need to evaluate community-based psychosocial interventions for refugees.

• Community-based sociotherapy has been used to support communities in post-conflict situations but has not been evaluated in a randomised controlled trial.

• This protocol outlines a proposed randomised controlled trial of community-based sociotherapy adapted for Congolese refugees in Uganda and Rwanda.

Antecedentes: El conflicto en la República Democrática del Congo ha llevado a un gran número de refugiados a huir a Uganda y Ruanda. Los refugiados experimentan niveles elevados de eventos adversos y factores estresantes diarios, que se asocian con problemas de salud mental comunes, como la depresión. El ensayo controlado aleatorio grupal actual tiene como objetivo investigar si una forma adaptada de socioterapia basada en la comunidad (aCBS en su sigla en inglés) es efectiva y rentable para reducir la sintomatología depresiva experimentada por los refugiados congoleños en Uganda y Ruanda.

Método: Se llevará a cabo un ensayo controlado aleatorizado por conglomerados simple ciego (cRCT, por sus siglas en inglés) de dos brazos en el asentamiento de Kyangwali, Uganda y el campamento de Gihembe, Ruanda. Sesenta y cuatro grupos serán reclutados y asignados aleatoriamente a aCBS o a la condición de cuidado usual mejorado (ECAU en su sigla en inglés). aCBS, una intervención grupal de 15 sesiones, será facilitada por dos personas provenientes de las comunidades de refugiados. La medida de resultado primaria serán los niveles autoinformados de sintomatología depresiva (PHQ-9) a las 18 semanas posteriores a la aleatorización. Los resultados secundarios incluirán niveles de dificultades de salud mental, bienestar subjetivo, estrés posterior al desplazamiento, apoyo social percibido, capital social, calidad de vida y síntomas de TEPT a las 18 y 32 semanas posteriores a la aleatorización. La rentabilidad de aCBS se medirá en términos de costos de atención médica (costo por año de vida ajustado por discapacidad, DALY en su sigla en inglés) en comparación con ECAU. Se llevará a cabo una evaluación del proceso para investigar la implementación de aCBS.

Conclusión: Este cRCT será el primero en investigar aCBS para las dificultades de salud mental que experimentan los refugiados y contribuirá al conocimiento sobre el uso de intervenciones psicosociales para refugiados en un momento en que los niveles de migración forzada están en un nivel récord.

Registro de ensayo: ISRCTN20474555

背景：刚果民主共和国的冲突导致大量难民逃往乌干达和卢旺达。难民经历了更高水平的不良事件和日常应激源，这与抑郁等常见心理健康问题有关。当前的集群随机对照试验旨在考查一种改编形式的社区社会疗法 (aCBS) 在减少乌干达和卢旺达的刚果难民所体验到的抑郁症状方面是否有效且具有成本效益。

方法：将在乌干达康瓦利定居点和卢旺达吉亨贝营地进行双臂、单盲集群随机对照试验 (cRCT)。将招募 64个集群并随机分配给 aCBS 或加强日常护理 (ECAU)。 aCBS 是一项 15 个疗程的团体干预，将由来自难民社区的两名人员引导。主要结果指标将是随机分组后 18 周时自我报告的抑郁症状水平 (PHQ-9)。次要结果将包括随机分组后 18 周和 32 周的心理健康困难水平、主观幸福感、流离失所后应激、社会支持感、社会资本、生活质量和 PTSD 症状。与 ECAU 相比，aCBS 的成本效益将根据医疗保健成本（每个残疾调节生命年的成本，DALY）来衡量。将进行过程评估以考查 aCBS 的实施情况。

结论：本 cRCT 将是第一个针对难民所经历心理健康困难 aCBS的考查，将有助于了解在被迫移民水平达到历史最高水平时对难民使用社会心理干预的知识。

试验注册：ISRCTN20474555

KEYWORDS:

• Refugees
• psychosocial
• mental health
• depression
• sociotherapy
• trial protocol

PALABRAS CLAVE:

• Refugiados
• psicosocial
• salud mental
• depresión
• socioterapia
• protocolo de ensayo

关键词:

• 难民
• 社会心理
• 心理健康
• 抑郁
• 社会治疗
• 试验方案

Acknowledgement

We would like to acknowledge the CoSTAR data collection teams in Rwanda and Uganda: Tasdik M. Hassan, Hosanne Ingabire, Alice Ishimwe, Aimee Mukankusi, Romain Ndikumuzima, Eric Niyonteze, Nicole Iraguha, Barbara Nalwoga Kawooya, Hillary Asiimwe, Bosco Lodu, Joseph Mugarura

Disclosure statement

No potential conflict of interest was reported by the author(s).

Contributors

The opinions expressed in this paper are those of the authors and do not necessarily represent the decisions, policies or views of the organisations they serve.

Ethical standards

The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees. Firstly, Ethical approvals were received from the Ethical Review Board at the University of Rwanda, and Makerere University, Uganda National Council for Science and Technology and from the sponsoring institution’s Central Research Ethics Committees at the University of Liverpool. Secondly, clearance to conduct research study in Uganda and Rwanda refugee settings was received from the Office of the Prime Minister and the Ministry of Emergency Management respectively.

Data availability statement

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

Additional information

Funding

This evaluation of the CBS intervention is supported by ESRC (Economic & Social research Council) under the ‘GCRF New Social and Cultural Insights into Mental, Neurological and Substance Use Disorders in Developing Countries’ funding call. Grant number (ES/S000976/1). The University of Liverpool is acting as the sponsor of the CoSTAR project.