Community-based Socio-therapy Adapted for Refugees: the COSTAR study.
| ISRCTN | ISRCTN20474555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20474555 |
| Secondary identifying numbers | ES/S000976/1 |
- Submission date
- 15/03/2019
- Registration date
- 27/03/2019
- Last edited
- 09/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The experience of conflict can have significant impacts on social relationships within communities. Community Based Sociotherapy (CBS) is a group-based approach that aims to help communities to heal after experiences of conflict. CBS runs over 15 weekly sessions. During CBS group meetings people talk, participate in exercises and games, sing songs, and engage in other forms of cultural expressions. This helps group members to address issues that can include ongoing daily stress, difficulties from the past and threats to safety and trust within their communities. CBS has been used in post-genocide Rwanda. Conflict in neighbouring Democratic Republic of Congo have led to large numbers of refugees being forcibly displaced to both Rwanda and Uganda. The COSTAR Project aims to investigate whether an adapted form of CBS can be used to reduce the levels of depression symptoms experienced by Congolese refugees in Rwanda and Uganda.
Who can participate?
Female and male, adult Congolese refugees living in Gihembe refugee camp in Rwanda and Kyangwali refugee settlement in Uganda can participate.
What does the study involve?
The COSTAR project is a randomized controlled trial. This means that participants are assigned by chance to either participate in CBS groups or participate in group meetings that simply provide those attending with updates about life in the refugee settlement. The participants will all complete a range of questionnaires that assess levels of depression symptoms, wellbeing, social support, social relationships, trauma, and daily stress. The participants will complete these questionnaires on three occasions: at the beginning, after 18 weeks and finally after 32 weeks. The COSTAR project will also investigate whether CBS is good value for money.
What are the possible benefits and risks of participating?
Each CBS group meetings will be facilitated by two facilitators who come from the refugee communities. They will be trained by the project team. Those participating in the trial may benefit from attending group meetings. The group meetings may involve discussion of emotive topics. The facilitators and research team members will be trained in how to support participants who may become distressed.
Where is the study run from?
The COSTAR Project is a collaboration between University of Liverpool (UK), Makerere University (Uganda), University of Rwanda (Rwanda), University of Glasgow (UK) and Queen’s University Belfast (UK)
When is the study starting and how long is it expected to run for?
June 2019 to September 2022
Who is funding the study?
The Economic and Social Research Council
Who is the main contact?
Prof. Ross G. White, r.white@qub.ac.uk
Contact information
Scientific
University of Liverpool
School of Psychology
G.10, Ground floor, Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
 ORCID ID |
0000-0003-4026-6439 |
|---|---|
| Phone | 0151 794 5532 |
| ross.white@liverpool.ac.uk |
Public
School of Psychology
Queen's University Belfast
Room 03.528, David Keir Building
8-30 Malone Road
Belfast
BT9 5BN
United Kingdom
| Phone | +44 (0)28 9097 6566 |
|---|---|
| r.white@qub.ac.uk |
Study information
| Study design | Two-arm cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Treating depressive symptomatology in Congolese refugees in Uganda and Rwanda: Adapting and evaluating community-based socio-therapy |
| Study 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(s) | 1. Approved 22/11/2018, Makerere University (School of Social Sciences Research and Ethics Committee, Makerere University College of Humanities and Social Sciences, P. O Box 7062, Kampala- Uganda; 256 41(+256) 0414 -545040; 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) |
| Condition | Depressive symptomatology of Congolese refugees |
| 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 the trial, steps will be taken to organize the delivery of the intervention in a way that will prevent potential contamination. |
| Intervention type | Behavioural |
| 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 study start date | 01/06/2019 |
| Overall study end date | 30/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 640 (320 per study arm) |
| Total final enrolment | 1042 |
| Participant 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). |
| 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 | 31/03/2021 |
Locations
Countries of recruitment
- Rwanda
- Uganda
Study participating centre
Gikondo - Street, KK 737
PO Box 4285
Kigali
4285
Rwanda
Sponsor information
University/education
Research Support Office 2nd Floor Block D Waterhouse Building 3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
| Phone | 0151 794 8373 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | https://www.liverpool.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 20/01/2023 | 14/04/2023 | Yes | No |
Editorial Notes
09/06/2023: The following changes were made to the study record:
1. The total final enrolment number was added.
2. The intention to publish date has been changed from 31/12/2022 to 31/12/2023.
14/04/2023: Publication reference added.
05/05/2022: The plain English summary has been added.
29/04/2022: The trial website has been updated.
27/04/2022: A public contact has been added.
11/04/2022: The overall trial end date has been changed from 31/03/2022 to 30/09/2022.
03/03/2022: The intention to publish date has been changed from 31/05/2022 to 31/12/2022.
08/09/2021: The overall trial end date has been changed from 30/09/2021 to 31/03/2022.
08/02/2021: The following changes were made to the trial record:
1. Recruitment to this study is no longer paused.
2. The recruitment end date was changed from 28/02/2021 to 31/03/2021.
3. The overall trial end date was changed from 30/05/2021 to 30/09/2021.
4. The target number of participants was changed from 720 (360 per study arm) to 640 (320 per study arm).
06/08/2020: The recruitment end date.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
25/07/2019: Internal review.
22/07/2019: The following changes were made to the trial record:
1. The ethics approval (1) was changed from "Makerere University (Faculty of Medicine Research and Ethics Committee)" to "Makerere University (School of Social Sciences Research and Ethics Committee)"
2. In the interventions "Nakivale" was changed to "Kyangwali".
3. In the participant inclusion criteria "Nakivale" was changed to "Kyangwali".
25/03/2019: Trial’s existence confirmed by IRB
