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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906487904130 Date of Registration: 28/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ecosocial Intervention for Strengthening Mental Health
Official scientific title Data Analysis of an Internal Evaluation of HOPEthiopia Program for Community Resiliency Training in Rwanda
Brief summary describing the background and objectives of the trial Support for the mental health of conflict-exposed populations is a significant challenge worldwide. Although evidence-based approaches do exist, numerous impediments exist to their effective application. The objective of this study is to evaluate the impact of a community-based program for strengthening the mental health of conflict-exposed populations.
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 Treatment: Other
Anticipated trial start date 07/01/2014
Actual trial start date 07/01/2019
Anticipated date of last follow up 05/06/2014
Actual Last follow-up date 05/06/2014
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 26
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Collaborative Resiliency Training 8 Sessions of 3.5 hours 6 weeks A manualised, community-based intervention for supporting the cultivation of practical skills for self-care and mutual support. 14
Control Group Waitlisted Control Group None None The control group was offered the intervention upon completion of the trial. 12 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Attendance at preliminary evaluation session Membership in AERG (Student association of genocide survivors) Concurrent psychiatric or mental health intervention History of severe mental illness (bipolar or psychotic) Concurrent substance abuse or addiction Significant suicidal ideation Active involvement in the local organising committee of AERG Adult: 18 Year(s)-44 Year(s) 20 Year(s) 26 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 15/11/2016 Albert Einstein College of Medicine
Ethics Committee Address
Street address City Postal code Country
Montefiore Medical Center, 3308 Rochambeau Avenue, Bronx, New York, 10467 Bronx 10467 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Multivariate analysis of PTSD, depression and anxiety symptoms Week 0 - pre-intervention, Week 6 - post-intervention, Week 14 - follow-up
Secondary Outcome PTSD symptoms - Symptom Checklist of Harvard Trauma Questionnaire Week 0 - pre-intervention, Week 6 - post-intervention, Week 14 - follow-up
Secondary Outcome Depression symptoms - Hopkins Symptom Checklist Week 0 - pre-intervention, Week 6 - post-intervention, Week 14 - follow-up
Secondary Outcome Anxiety Symptoms - Hopkins Symptom Checklist Week 0 - pre-intervention, Week 6 - post-intervention, Week 14 - follow-up
Secondary Outcome High-Frequency Heart Rate Variability Week 0 - pre-intervention, Week 6 - post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
HOPEthiopia Inindi House, Kicukiro Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Resnick Campus - Rousseau Building, Room 124 Bronx 10461 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yeshiva University 500 West 185th Street New York 10033 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Janina Achtert Steigfeldstrasse 33 Garmisch Partenkirchen 82467 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Carl Auerbach carl.auerbach@yu.edu +16465924389 Resnick Campus - Rousseau Building, Room 124
City Postal code Country Position/Affiliation
Bronx 10461 United States of America Professor Yeshiva University
Role Name Email Phone Street address
Scientific Enquiries Carl Auerbach carl.auerbach@yu.edu +6465924389 Resnick Campus - Rousseau Building Room 124
City Postal code Country Position/Affiliation
Bronx 10461 United States of America Professor Yeshiva University
Role Name Email Phone Street address
Public Enquiries Jonathan Nattel jon.nattel@gmail.com +18458684136 Inindi House
City Postal code Country Position/Affiliation
Kicukiro Rwanda Psychosocial Development Coordinator HOPEthiopia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results of this study will be made available by publication. Individual participant data will not be made publicly available. Study Protocol Study protocol will be made available upon publication. Will remain available for one year. Publicly available
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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