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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65771265

Enrollment

311

Registered

2016-06-27

Start date

2017-04-03

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 beca

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Tanzania

Contacts

Public ContactM. Claire Greene

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026