Condition category
Mental and Behavioural Disorders
Date applied
13/06/2016
Date assigned
27/06/2016
Last edited
12/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Intimate partner violence is a major concern in refugee camps, as well as putting people at risk of mental health issues such as anxiety and depression (psychological distress). Studies have shown that psychological distress and intimate partner violence are directly related, in that intimate partner violence causes worse mental health and in turn mental health issues can increase risk of further intimate partner violence. It can be very difficult to break this cycle, and so an approach that addresses both mental health and the violence is necessary (integrated approach). The Nguvu (Kiswahili for strength and energy) project is an integrated approach designed to address these issues, through a combination of empowerment (providing information, discussing options and helping women make safe and informed choices to reduce violence) and psychological support (reducing emotional difficulties resulting from violence exposure). The aim of this study is to investigate the effectiveness of this program at reducing psychological distress and preventing future intimate partner violence.

Who can participate?
Women who are refugees from the Democratic Republic of the Congo (DRC) currently living in Nyarugusu Refugee Camp (Tanzania) and participating in local women’s groups who have a history of intimate partner violence and are experiencing psychological distress.

What does the study involve?
The Nyarugusu Refugee Camp is divided into seven zones for Congolese refugees, which are further subdivided into 52 villages. Local women’s groups are organized within these villages and operate as opportunities for women to develop skills and strengthen their social networks. There are 59 women’s groups located in zones two through seven, which are randomly allocated into one of two study conditions: usual care with and without Nguvu. Participants recruited from women’s groups in the first group take part in the Nguvu program. Women’s groups in zone one are not included in the trial as this served as the sampling frame for our recently completed pilot study. The Nguvu program involves weekly sessions over eight weeks. Sessions one and eight focus on developing a safety plan and discussing issues surrounding intimate partner violence and psychological distress. Sessions two-seven focus on learning techniques to help identify stuck thoughts and learn skills to change ways of thinking that lead to psychological distress. Those living in villages in the usual care condition receive access to standard mental health and protection services during the eight week study period. This includes gender-based violence prevention and response services provided by the International Rescue Committee in Nyarugusu camp and mental health services provided by the Tanzania Red Cross. At the start of the study and then after nine and twenty weeks, participants in both groups complete a number of questionnaires to measure psychological distress and to find out if they have experienced any further intimate partner violence.

What are the possible benefits and risks of participating?
Participants who take part in the Nguvu program may benefit from reduced levels of distress and intimate partner violence. Participants who receive the standard care services are also likely to benefit in this way should they choose to use the services that are available. The main risks of this study involve possible discomfort when discussing personal topics related to mental health and intimate partner violence and social/safety risks if the participant’s partner or other community members are aware of their participation.

Where is the study run from?
The study is run from the Muhimbili University of Health and Allied Sciences and takes place in the Nyarugusu Refugee Camp (Tanzania)

When is the study starting and how long is it expected to run for?
October 2014 to October 2017

Who is funding the study?
1. Wellcome Trust (UK) Reference: R2HC initiative
2. Department for International Development (UK)

Who is the main contact?
1. Miss M Claire Greene (public)
2. Mr Wietse A Tol (scientific)

Trial website

Contact information

Type

Public

Primary contact

Miss M. Claire Greene

ORCID ID

http://orcid.org/0000-0002-4631-4764

Contact details

Johns Hopkins Bloomberg School of Public Health
624 North Broadway
Rm. 888
Baltimore
21205
United States of America

Type

Scientific

Additional contact

Mr Wietse A. Tol

ORCID ID

http://orcid.org/0000-0003-2216-0526

Contact details

Johns Hopkins Bloomberg School of Public Health
624 North Broadway
Rm. 863
Baltimore
21205
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Nguvu: A randomized controlled trial of an integrated intervention to reduce intimate partner violence and psychological distress in adult, female Congolese refugees in Tanzania

Acronym

Study hypothesis

1. Women in the intervention condition (consisting of the 8-session Nguvu intervention and access to intervention as usual) will report fewer incidents of intimate partner violence and experience less psychological distress post-intervention relative to intervention as usual
2. The intervention will increase social support/capital, self-efficacy and adaptive coping skills, which will further reduce recurrent intimate partner violence and psychological distress

Ethics approval

1. Johns Hopkins Bloomberg School of Public Health, 20/09/2016, ref: 00007219
2. Muhimbili University of Health and Allied Sciences, Tanzania, 20/10/2015, ref: 2014-10-27/AEC/Vol.X/56
3. National Institute of Medical Research, Tanzania, 11/09/2015 ref: NIMR/HQ/R.8a/Vol.1X/2016

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Psychological distress (e.g. depressive, anxiety or post-traumatic stress symptoms) in refugees with a past-year history of intimate partner violence

Intervention

Correct as of 12/06/2017:
Nyarugusu is divided into 7 zones for Congolese refugees, which are further subdivided into 52 total villages.

One of the zones (zone 1) will be excluded from the trial because it was used as the site for the pilot study. In zones 2-7 there are 59 women’s groups organized within the villages, which will serve as the cluster and source of recruitment for the study.

Staff not working for the project at Johns Hopkins Bloomberg School of Public Health will randomize women’s groups in zones 2-7 into the intervention and control condition using approximately a 1:1 allocation ratio through a random number generator in the Stata. The allocation of villages to intervention and control condition will be concealed from the local research assistants.

Intervention (Nguvu) Arm: Participants will have access to the Nguvu intervention, which is an 8-week program that integrates advocacy and empowerment counseling with cognitive processing therapy. The intervention was developed from previous programs evaluated in survivors of sexual and gender-based violence and adapted through formative research conducted in Nyarugusu refugee camp. The intervention consists of weekly sessions over the course of 8 weeks (1 individual session followed by 7 group sessions). Sessions 1 and 8 are the advocacy sessions, which focus on developing a safety plan and discussing issues surrounding intimate partner violence and psychological distress. Sessions 2-7 are the cognitive processing therapy sessions that introduce concepts and the relationship between thoughts and feelings and teach participants skills to identify stuck thoughts and introduce skills to change thinking errors as a means to improve feelings and reduce psychological stress.

Comparison group: Participants will receive standard mental health and protection services during the trial period. Protection services include gender-based violence prevention and response services provided by the International Rescue Committee in Nyarugusu camp. The mental health services are provided primarily through the health sector, primarily provided by the Tanzania Red Cross, and some psychosocial services are offered through the protection sector.

Participants in both groups are followed up after 9 and 20 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Recurrence of intimate partner violence is measured using the Domestic Violence Module of the Demographic and Health Survey at baseline, 9 and 20 weeks post-enrollment
2. Psychological distress symptoms are measured using the 25-item Hopkins Symptom Checklist (HSCL-25) and PTSD Symptom Items in the Harvard Trauma Questionnaire (HTQ) at baseline, 9 and 20 weeks post-enrollment

Secondary outcome measures

Functional impairment measured using 12 items developed from qualitative data at baseline, 9 and 20 weeks post-enrollment

Overall trial start date

01/10/2014

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 29/03/2017:
1. Aged 18 years and over
2. Female
3. Refugee from the Democratic Republic of the Congo (DRC) currently residing in Nyarugusu Refugee Camp, Tanzania
4. Participating in a local women’s groups
5. Past-years history of intimate partner violence: endorsing any past-year intimate partner violence on a modified version of the Abuse Assessment Screen (AAS)
6. Experiencing moderate-severe psychological distress: Average score of moderate to severe (≥1.75 out of 4) on items assessing depressive or anxiety symptoms; or ≥ 1.0 out of 3 on items assessing post-traumatic stress symptoms. Depressive and anxiety symptoms were measured using the 25-item Hopkins Symptom Checklist (HSCL). Post-traumatic stress symptoms were measured using the 16-item Harvard Trauma Questionnaire (HTQ)

Original inclusion criteria 4-5:
4. Past-years history of intimate partner violence: endorsing any past-year intimate partner violence on a modified version of the Abuse Assessment Screen (AAS)
5. Experiencing moderate-severe psychological distress: Average score of moderate to severe (>1.75 out of 4) on items assessing depressive, anxiety or post-traumatic stress symptoms. Depressive and anxiety symptoms were measured using the 25-item Hopkins Symptom Checklist (HSCL). Post-traumatic stress symptoms were measured using the 16-item Harvard Trauma Questionnaire (HTQ).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400

Participant exclusion criteria

1. Serious mental illness
2. Substance use disorder
3. Imminent risk of suicide

Recruitment start date

03/04/2017

Recruitment end date

31/08/2017

Locations

Countries of recruitment

Tanzania

Trial participating centre

Muhimbili University of Health and Allied Sciences (MUHAS)
United Nations Road
Dar es Salaam
N/A
Tanzania

Sponsor information

Organisation

Johns Hopkins Bloomberg School of Public Health

Sponsor details

615 North Wolfe Street
Baltimore
21205
United States of America

Sponsor type

University/education

Website

www.jhsph.edu

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of study results in a high impact journal within 1 year from the trial end date.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from the Principal Investigator, Wietse Tol (wtol1@jhu.edu).

Intention to publish date

30/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28521751

Publication citations

Additional files

Editorial Notes

12/06/2017: The interventions have been updated to include 59 rather than 63 women’s groups. 22/05/2017: Publication reference added. 29/03/2017: The following changes have been made to the record: 1. In the interventions section, the clusters have been updated and the follow up period shortened from 24 to 20 weeks 2. In the outcome measures, the second follow up timepoint has been changed from 24 to 20 weeks 3. The target number of participants has been updated from 360 to 400 4. The overall trial end date has been updated from 30/04/2017 to 01/10/2017 5. The recruitment dates have been updated from 01/08/2016 - 31/08/2016 to 03/04/2017 - 31/08/2017 6. The publication and dissemination plan has been updated 7. The plain English summary has been updated to reflect the other changes to the record 8. The IPD Sharing plan has been added