Nguvu: Evaluating an integrated approach to reduce intimate partner violence and psychological distress in refugees in Tanzania

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN65771265
• Date of registration: 27/06/2016
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins Bloomberg School of Public Health
• Public title: Nguvu: Evaluating an integrated approach to reduce intimate partner violence and psychological distress in refugees in Tanzania
• 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
• Date of first enrolment: 03/04/2017
• Target sample size: 311
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN65771265
• Study type: Interventional
• Study design: Study design as of 31/10/2018: Single-centre randomized pilot controlled trial Previous study design: Single-centre randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Tanzania

Contacts

• Name: M. Claire Greene

• Name: Wietse A. Tol

Key inclusion & exclusion criteria

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).
Exclusion criteria: 1. Serious mental illness
2. Substance use disorder
3. Imminent risk of suicide

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

Primary outcome measures as of 07/11/2018:
1. Relevance of the intervention and research protocols
1.1. To determine whether psychological distress is a prevalent problem that is prioritized by women affected by intimate partner violence in refugee settings
1.2. To evaluate the validity and reliability of mental health, violence and functioning outcome measures in the study population
2. Acceptability of the intervention and research protocols
2.1. Participant retention in intervention sessions and research interviews (75% of intervention sessions attended, on average; 85% retention in post-treatment assessment)
2.2. No serious adverse events related to study participation
2.3. Safety and ethical concerns reported in qualitative interviews with participants and program staff
3. Feasibility of the intervention and research protocols
3.1. Fidelity of intervention implementation as determined through supervision, qualitative interviews with intervention facilitators and routine monitoring for protocol deviations
3.2. Recruitment of 15 groups of eligible women (approximately n=150-180) and approximately equal number of controls within 3 months
3.3. Balanced randomization groups on demographics and baseline levels of outcome measures
3.4. Implementation challenges reported in qualitative interviews with program staff and partner agency representatives, changes in anticipated timelines, etc.
3.5. Monitoring of research protocol deviations to inform adaptations to recruitment, randomization, assessment, and follow-up procedures

Previous 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(s)

Secondary outcome measures as of 07/11/2018:
1. Recurrence of intimate partner violence as measured using the Domestic Violence Module of the Demographic and Health Survey at baseline and post-treatment assessments
2. Psychological distress symptoms as measured using the 25-item Hopkins Symptom Checklist (HSCL-25) and PTSD symptom items in the Harvard Trauma Questionnaire at baseline and post-treatment assessments
3. Functional impairment as measured using 12 items developed from qualitative data at baseline and post-treatment assessments

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

Secondary ID(s)

N/A

Nil known

Source(s) of Monetary Support

Wellcome Trust, Department for International Development

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 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

Results

• Results available: Yes
• Date Completed: 01/10/2017