Condition category
Mental and Behavioural Disorders
Date applied
13/03/2017
Date assigned
27/04/2017
Last edited
27/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

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

http://www.who.int/en/

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/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes