Self-help plus (SH+) for South Sudanese refugees in Uganda

• Register: ISRCTN
• Last refreshed on: 26 September 2023
• Main ID: ISRCTN50148022
• Date of registration: 27/04/2017
• Prospective Registration: No
• Primary sponsor: World Health Organization
• Public title: Self-help plus (SH+) for South Sudanese refugees in Uganda
• Scientific title: Guided self-help to reduce psychological distress in South Sudanese refugees in northern Uganda: a cluster randomized trial
• Date of first enrolment: 20/03/2017
• Target sample size: 560
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN50148022
• Study type: Interventional
• Study design: Cluster randomized trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Wietse Tol

Key inclusion & exclusion criteria

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

Exclusion criteria:
1. Imminent risk of suicide
2. Observable signs of severe mental disorder


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Psychological distress
Mental and Behavioural Disorders
Psychological distress

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

SH+UG

Source(s) of Monetary Support

Enhancing Learning & Research for Humanitarian Assistance (ELRHA) Research for Health in Humanitarian Crises (R2HC)

Secondary Sponsor(s)

World Health Organization

Peter C. Alderman Foundation

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. World Health Organization Ethics Review Committee, 12/07/2016, ref: RPC758 2. MildMay Uganda Research Ethics Committee, 04/10/2016, ref: #RECREF0307-2016

Results

• Results available: Yes
• Date Completed: 16/01/2018