Plain English Summary
Background and study aims
Refugees are at risk of psychological distress and a range of mental disorders. The aim of this study is to test a new guided self-help intervention with South Sudanese refugee women in northern Uganda. The guided self-help intervention is designed to reduce high psychological distress in hard to access humanitarian populations.
Who can participate?
Women aged 18 or older who speak Juba Arabic, reside in the Rhino Camp refugee settlement area in the West Nile region in northern Uganda, with high psychological distress
What does the study involve?
Participating villages in the Rhino Camp refugee resettlement area are randomly allocated into two groups. Women in one group are invited to participate in five sessions of two hours of audio-recorded guided self-help, with a picture-book that illustrates the audio material. Women in the other group receive enhanced usual care, consisting of a community health care worker describing psychological distress, its causes, and what one can do to decrease psychological distress; and access to existing mental health services provided at primary care facilities. Various indicators of mental health are measured before, immediately after, and 3 months after completion of the intervention.
What are the possible benefits and risks of participating?
Likely benefits include reduced psychological distress and improved wellbeing. Discussion of difficult feelings may lead to temporary increases in psychological distress. In two small previous studies this risk has not been observed occurring.
Where is the study run from?
Peter C. Alderman Foundation (Uganda)
When is the study starting and how long is it expected to run for?
May 2016 to January 2018
Who is funding the study?
Enhancing Learning & Research for Humanitarian Assistance (ELRHA) Research for Health in Humanitarian Crises (R2HC)
Who is the main contact?
Dr Wietse Tol
Trial website
Contact information
Type
Scientific
Primary contact
Dr Wietse Tol
ORCID ID
http://orcid.org/0000-0003-2216-0526
Contact details
PCAF Uganda
Mawanda Road Plot #855
Kampala
-
Uganda
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SH+UG
Study information
Scientific title
Guided self-help to reduce psychological distress in South Sudanese refugees in northern Uganda: a cluster randomized trial
Acronym
Study hypothesis
A guided self-help intervention will lead to larger reductions in psychological distress than enhanced usual care.
Ethics approval
1. World Health Organization Ethics Review Committee, 12/07/2016, ref: RPC758
2. MildMay Uganda Research Ethics Committee, 04/10/2016, ref: #RECREF0307-2016
Study design
Cluster randomized 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 the contact details to request a patient information sheet
Condition
Psychological distress
Intervention
Villages in the Rhino Camp refugee resettlement area are randomised to the following two conditions. Interviewers will be masked for study condition of villages.
1. The intervention condition will consist of a guided self-help intervention called Self-Help Plus (SH+). SH+ consists of five two-hour audio-recorded sessions, facilitated by a lay facilitator, as well as a picture book that illustrates the material from the audio sessions. The intervention comprises 2-hour sessions, weekly, for 5 weeks.
2. The control condition will consist of enhanced usual care, consisting of psycho-education by trained community health workers and access to mental health care services delivered in nearby health centers.
Various indicators of mental health are measured before, immediately after, and 3 months after completion of the intervention.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Psychological distress, assessed using the Kessler 6 (K6) at pre-treatment (included as screening measure), immediately post-treatment, and 3 months after completion of treatment
Secondary outcome measures
Secondary outcomes:
1. Functional impairment, measured using the World Health Organization Disability Assessment Schedule 2.0, 12-item, interviewer administered version
2. Self-defined psychosocial goals, measured using PSYCLOPS
3. Depression symptoms, measured using the Patient Health Questionnaire 9 (PHQ-9)
4. Post-traumatic stress disorder symptoms, measured using the Posttraumatic Checklist 6 Civilian Version (PCL-C6)
5. Subjective wellbeing, measured using the World Health Organization Wellbeing 5 (WHO-5)
Mediator:
1. Psychological flexibility, measured using the Acceptance and Action Questionnaire 2 (AAQ-2)
Moderators:
1. Exposure to potentially traumatic events, measured using the Harvard Trauma Questionnaire (HTQ), part A
2. (Additional) health service use, measured using survey questions designed for this study
Other:
1. Economic indicators (for cost-benefit analyses), measured using survey questions designed for this study
2. Treatment contamination check, measured using survey questions designed for this study
All outcomes, mediators, moderators and the economic indicators are assessed at pre-treatment, immediately post-treatment, and 3 months after completion of treatment by a masked team of interviewers not involved in service delivery. To ensure masking, the contamination measure will be administered by intervention facilitators, between the immediate post-treatment follow-up and the 3-month follow-up.
Overall trial start date
20/05/2016
Overall trial end date
16/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (18 years or older)
2. Women
3. Speaking Juba Arabic
4. Residing in the Rhino Camp refugee settlement area in the West Nile region in northern Uganda
5. Scoring above an established cut-off for psychological distress on the K6
Participant type
Other
Age group
Adult
Gender
Female
Target number of participants
14 villages (7 in the intervention condition, 7 in enhanced usual care condition); screening in 2 groups of 20-25 participants in each village, for a total of 560-700 participants
Total final enrolment
694
Participant exclusion criteria
1. Imminent risk of suicide
2. Observable signs of severe mental disorder
Recruitment start date
20/03/2017
Recruitment end date
13/04/2017
Locations
Countries of recruitment
Uganda
Trial participating centre
Peter C. Alderman Foundation Uganda
Mawanda Road Plot#855
Kampala
-
Uganda
Sponsor information
Organisation
World Health Organization
Sponsor details
Avenue Appia 20
Geneva
1211
Switzerland
Sponsor type
Other
Website
Organisation
Peter C. Alderman Foundation
Sponsor details
261 Madison Avenue
9th Floor
New York
NY
10016
United States of America
Sponsor type
Other
Website
http://www.petercaldermanfoundation.org/
Organisation
World Health Organization
Sponsor details
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Enhancing Learning & Research for Humanitarian Assistance (ELRHA) Research for Health in Humanitarian Crises (R2HC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Mark van Ommeren, World Health Organization or Wietse Tol, Peter C. Alderman Foundation.
Intention to publish date
16/01/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30128163 (added 01/08/2019)
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31981556 (added 27/01/2020)