Community-based Socio-therapy Adapted for Refugees: the COSTAR study.

INTERVENTION: The Adapted Community Based Sociotherapy (aCBS) intervention is delivered in groups of 10 to 15 people living in the same geographic area (e.g. villages in camps). The aCBS intervention does not target specific diagnoses or symptoms. Rather attention is placed on being inclusive of all people in the community. Thus, aCBS minimises the potential stigma associated with disorder‐focused interventions. Training and supervision for 24 facilitators across Rwanda and Uganda will be provided by CBS Rwanda (an organisation with 15 years’ experience of delivering CBS in Rwanda). The fidelity of aCBS delivery will be monitored in a subset (10%) of randomly selected sessions using an existing checklist that is completed by field staff. Clusters of participants (e.g. villages) in the Gihembe camps and the Kyangwali (updated 22/07/2019, previously: Nakivale) settlement will be randomised to aCBS or ECU with a ratio of 1:1. Randomisation will be conducted independently by the Clinical Trials Research Centre (CTRC), University of Liverpool. The outcome of the randomisation will be communicated directly to the Trial Coordinator based at University of Rwanda. In the selected clusters, participants will be recruited through door‐to‐door approach. This approach has been used successfully in refugee camps in Uganda. Participants will be recruited prior to randomization of clusters. Informed consent will be obtained from participants. Outcome assessors will be blind to group allocation. There is a theoretical possibility of contamination by recruiting refugees who might interact each other and therefore divulge intervention components from people in the experimental arm to those in the control condition. In order to minimize the possibility of any form of contamination, both the experimental and the control group will be asked to refrain from sharing study‐related information and materials during the study. At all possible times during CONDITION: Depressive symptomatology of Congolese refugees ; Mental and Behavioural Disorders PRIMARY OUTCOME: 1. Depressive symptomatology score as measured on the PHQ‐937 at 16‐weeks (primary endpoint) and 32‐weeks (secondary endpoint) compared between the aCBS programme and ECU. SECONDARY OUTCOME: ; 1. Self‐Reporting Questionnaire for detecting CMDs in primary health care settings.; 2. Checklist for Daily Life Stressors (CDES), WHO‐5 for wellbeing.; 3. WHO Quality of Life BREF, Shortened and Adapted Social Capital Assessment Tool, PTSD Check List – Screener (PCL‐6) and Multi‐dimensional Scale of Perceived Social Support to measure social connectivity.; ; Outcomes will be assessed at baseline, and at 16‐ (primary outcome)‐ and 32‐weeks (secondary outcome) post‐baseline. The Major Depressive Episode module of the MINI will be used at baseline only.; INCLUSION CRITERIA: 1. Adult < 18 years 2. Living in Kyangwali (updated 22/07/2019, previously: Nakivale) settlement, Uganda and Gihembe refugee camp, Rwanda 3. Identify as Congolese refugees 4. Have a self‐reported good level of fluency in the languages that aCBS will be delivered in (Kinyarwanda in Rwanda / Kiswahili in Uganda).