Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407822896469 Date of Approval: 23/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Title: A Randomized Controlled Trial Evaluating the Efficacy of Community-Based Mental Health Approach among Refugees in Rwanda: Case of Mahama Camp.
Official scientific title A Randomized Controlled Trial Evaluating the Efficacy of Community-Based Mental Health Approach among Refugees in Rwanda: Case of Mahama Camp.
Brief summary describing the background and objectives of the trial Background: Community-based Mental Health Approach (CBHA) is an intervention that was initiated and implemented by Handicap international federation since 2016 with a contention to treat psychosocial problems among refugees and other vulnerable populations in post-conflict situations. However, there is a scarcity of studies evaluating the impact of CBHA in Rwanda and globally. Objectives: This study aimed to investigates the efficacy of CBHA for anxiety, depression, PTSD symptoms, and resilience among refugees residing in the Mahama camp in Rwanda
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 15/11/2023
Actual trial start date 15/07/2023
Anticipated date of last follow up 15/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community based mental health approach 12 weeks 12 weeks Community mental health approach A collection of decentralized initiatives aimed at offering persons with mental health problems in the community easily accessible, reasonably priced, socially acceptable, high-quality mental health care is defined as community mental health. The primary goal of these mental health services at community level is to enhance the life’s quality for the persons suffering from psychological issues by promoting early problem diagnosis, facilitating gain access to cost-effective treatment, strengthening inclusion in society, as well as ensuring livelihoods This approach is comprised by 3 groups: 1. Sharing groups :the objective is to raise aware the community about psychological problems by sensitizing them on the causes, signs and symptoms of mental disorders and tell them where the people can get psychosocial support and their roles in supporting vulnerable groups. 2. Healing groups (Therapeutic groups):Through peer group involvement that creates connections, interaction, and group dynamics, these therapeutic groups aim to enhance psychological well-being of those who are at risk. Participant sharing, expressing discomfort, and building connections with one another are all encouraged in discussion groups. These groups may be directed and planned by medical professionals, such as psychologists, with mainly therapeutic goals. When guided by social worker or group members having similar challenges, they also provide a type of peer support. 3. Self-help groups:By supporting Community Self-help Group (CSG) members in optimizing their own (collective) financial, social, and community resources, these self-help groups aim to ameliorate the psychological well-being of CSG members and empower them to satisfy their own wants and needs. 66
Control Group No intervention for control group during the study period NA 15 months (from baseline to one-year follow-up) without the intervention of a community-based mental health approach The control group will not receive a community-based mental health approach during the study period except the daily social support available in the refugee Camp. In the refugee camp, they receive food and non-food items, shelter, water, children's education support, and clothes among others. 66 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Being a refugee  Being aged 18 years and above.  Willingness to participate in our research. Clients who have communication impairment have not been allowed to participate in our research. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/03/2023 CMHS INSTITUTIONAL REVIEW BOARD
Ethics Committee Address
Street address City Postal code Country
KK 737 St, Kigali Kigali 4285kk Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Psychological Resilience. 15 months under the interventions/Community based mental health approach, baseline data collection in pre-intervention, 3 months follow-up immediately after the intervention and a year follow-up
Secondary Outcome PTSD symptoms, Depression, Anxiety 15 Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Rwanda KK 737 St, Kigali Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
UNIVERSITY OF RWANDA KK 737 St, Kigali Kigali 4285 KIG Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNIVERSITY OF RWANDA KK 737 St, Kigali Kigali 4285 KIG Rwanda University
COLLABORATORS
Name Street address City Postal code Country
Prof.MUTABARUKA Jean KK 737 St, Kigali kigali 4285 kig Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Germain UWIRAGIYE germaindagiye@gmail.com +250788555296 KK 737 St, Kigali
City Postal code Country Position/Affiliation
kigali Rwanda Masters program student
Role Name Email Phone Street address
Scientific Enquiries Prof.Jean MUTABARUKA batamu2003@yahoo.fr +25088891514 KK 737 St, Kigali
City Postal code Country Position/Affiliation
Kigali Rwanda Lecturer supervisor
Role Name Email Phone Street address
Public Enquiries Dr jeanne Marie NTETE ntjmarie@gmail.com +250788595432 KK 737 St, Kigali
City Postal code Country Position/Affiliation
kigali Rwanda Lecturer supervisor
Role Name Email Phone Street address
Scientific Enquiries Japhet Niyonsenga niyonsengajaphet74@gmail.com +250784010477 KK 208
City Postal code Country Position/Affiliation
Kigali Rwanda University of Rwanda
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent form, Study protocol, Statistical Analysis Plan, When will data be available (start and end date)? For what types of analyses? T-test and Mixed Anova Analytic Code,Clinical Study Report,Informed Consent Form,Study Protocol Start to the end: 15 November 2023 to 16 September 2024 Start to the end: 15 November 2023 to 16 September 2024 Start to the end: 15 November 2023 to 16 September 2024 Start to the end: 15 November 2023 to 16 September 2024 Start to the end: 15 November 2023 to 16 September 2024 The dataset with de-identified information will be available from the corresponding authors upon reasonable requests. The dataset with de-identified information will be available from the corresponding authors upon reasonable requests.The dataset with de-identified information will be available from the corresponding authors upon reasonable requests.The dataset with de-identified information will be available from the corresponding authors upon reasonable requests. The dataset with de-identified information will be available from the corresponding authors upon reasonable requests.The dataset with de-identified information will be available from the corresponding authors upon reasonable requests.The dataset with de-identified information will be available from the corresponding authors upon reasonable requests. The dataset with de-identified information will be available from the corresponding authors upon reasonable requests.The dataset with de-identified information will be available from the corresponding authors upon reasonable requests.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
NA No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information