Condition category
Mental and Behavioural Disorders
Date applied
15/03/2019
Date assigned
27/03/2019
Last edited
25/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Contact information

Type

Scientific

Primary contact

Dr Ross White

ORCID ID

http://orcid.org/0000-0003-4026-6439

Contact details

University of Liverpool
School of Psychology
G.10
Ground floor
Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
0151 794 5532
ross.white@liverpool.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ES/S000976/1

Study information

Scientific title

Treating Depressive Symptomatology in Congolese Refugees in Uganda and Rwanda: Adapting and Evaluating Community-based Socio-therapy

Acronym

COSTAR

Study hypothesis

1. Community based socio-therapy (CBS) intervention will be superior to enhanced care as usual (ECU) in lowering the levels of depressive symptomatology at 16- (primary endpoint) and 32-weeks (secondary endpoint) follow-up.
2. CBS will be superior to enhanced care as usual (ECU) in improving the levels of wellbeing and quality of life.
3. Refugees in the CBS intervention arm will incur lower health care costs compared to ECU group.

Ethics approval

1. Approved 21/12/2018, Makerere University (Faculty of Medicine Research and Ethics Committee
Makerere University College of Health Sciences, P. O Box 7072, Kampala- Uganda; 256 41(+256) 0414 -533541; research@chs.mak.ac.ug/rresearch9@gmail.com), ref: makss rec 11.18.237
2. Approved 07/02/2019 University of Rwanda (Ministry of Health, P.O.Box 84, Kigali, Rwanda; (250) 55 10 78 84; rnec@moh.gov.rw), ref: No 065/CMHS IRB/2019
3. The application for approval is now under processing at University of Liverpool (Liverpool L69 3BX;
+44 (0)151 794 2000; ethics@liverpool.ac.uk)

Study design

2-arm cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Depressive symptomatology of Congolese refugees residing in Gihembe Refugee Camp, Rwanda & Nakivale Refugee Settlement, Uganda

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 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 the trial, steps will be taken to organize the delivery of the intervention in a way that will prevent potential contamination.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 measures

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.

Overall trial start date

01/06/2019

Overall trial end date

30/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult < 18 years
2. Living in 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).

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

720 (360 per study arm)

Participant exclusion criteria

1. Current diagnosis of a complex mental disorder (e.g. psychotic disorders, PTSD, substance dependence)
2. Severe cognitive impairment (e.g. severe intellectual disability, dementia)
3. Actively express suicidal intent

Individuals that are excluded because of a diagnosis of a mental disorder or imminent risk of suicide will be referred for urgent local mental health support.

Recruitment start date

01/06/2019

Recruitment end date

30/07/2020

Locations

Countries of recruitment

Rwanda, Uganda

Trial participating centre

University of Rwanda
Kigali Gikondo - Street, KK 737 P.O. Box 4285
Kigali
4285
Rwanda

Sponsor information

Organisation

University of Liverpool

Sponsor details

Research Support Office 2nd Floor Block D Waterhouse Building 3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
0151 794 8373
sponsor@liverpool.ac.uk

Sponsor type

University/education

Website

https://www.liverpool.ac.uk/

Funders

Funder type

Research council

Funder name

Economic & Social Research Council (ES/S000976/1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Anonymised project data will be openly available and discoverable for analysis through the UK Data Service in accordance with the ESRC research data policy. There will be a dedicated project webpage and Twitter account to provide regular updates on progress. Video presentations relating to project relevant themes (e.g. refugee mental health and wellbeing; social capital; daily stressors) will be developed to serve as educational resources (1 online resource per 4 months). These will be freely available via the project webpage. Policy briefs will be developed with the UNHCR to inform decision-making for service allocation in refugee camps. Academic papers will be submitted to high impact peer reviewed journals including but not limited to The Lancet Psychiatry, Global Mental Health, Nature reviews, Psychological Medicine etc. Members of the project team will present at academic conferences and briefing sheets will be disseminated to communicate project-related content. Implementation guidance (co-published by UNHCR and CBS Rwanda) for adapting, disseminating and evaluating aCBS for refugees in diverse settings will be developed and made available through the Institute for Community-based Socio-therapy and UNHCR web-portals. These activities will promote enhanced understanding amongst clinicians, researchers and policy makers about how to promote mental health and wellbeing in refugees at a time of unprecedented global migration.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/05/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/03/2019: Trial’s existence confirmed by IRB