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

ISRCTN	ISRCTN50148022
DOI	https://doi.org/10.1186/ISRCTN50148022
Protocol serial number	SH+UG
Sponsors	World Health Organization, Peter C. Alderman Foundation, World Health Organization
Funder	Enhancing Learning & Research for Humanitarian Assistance (ELRHA) Research for Health in Humanitarian Crises (R2HC)

Submission date: 13/03/2017
Registration date: 27/04/2017
Last edited: 14/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Wietse Tol
Scientific

PCAF Uganda
Mawanda Road Plot #855
Kampala
-
Uganda

ORCID ID	0000-0003-2216-0526

Study information

Primary study design	Interventional
Study design	Cluster randomized trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Guided self-help to reduce psychological distress in South Sudanese refugees in northern Uganda: a cluster randomized trial
Study objectives	A guided self-help intervention will lead to larger reductions in psychological distress than enhanced usual care.
Ethics approval(s)	1. World Health Organization Ethics Review Committee, 12/07/2016, ref: RPC758 2. MildMay Uganda Research Ethics Committee, 04/10/2016, ref: #RECREF0307-2016
Health condition(s) or problem(s) studied	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
Primary outcome measure(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
Key secondary outcome measure(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.
Completion date	16/01/2018

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	560
Total final enrolment	694
Key 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
Key exclusion criteria	1. Imminent risk of suicide 2. Observable signs of severe mental disorder
Date of first enrolment	20/03/2017
Date of final enrolment	13/04/2017

Locations

Countries of recruitment

Uganda

Study participating centre

Peter C. Alderman Foundation Uganda

Mawanda Road Plot#855
Kampala
-
Uganda

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2020	27/01/2020	Yes	No
Results article	secondary analysis	12/09/2023	14/09/2023	Yes	No
Protocol article	protocol	13/08/2018	01/08/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/09/2023: Publication reference added.
27/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
01/08/2019: Publication reference added.