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Clinical Trials/NCT04841031
NCT04841031
Completed
Not Applicable

Psychosocial and Economic Impacts of Narrative Exposure Therapy for Violence Survivors in Eastern DRC

World Bank2 sites in 1 country1,053 target enrollmentJune 29, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Disorder
Sponsor
World Bank
Enrollment
1053
Locations
2
Primary Endpoint
Post-traumatic Stress Disorder (PTSD) Severity
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The objective of the study is to evaluate the impact of Narrative Exposure Therapy (NET) delivered by local counselors, on the mental health and socio-economic empowerment of survivors of Sexual and Gender Based Violence (SGBV) who suffer Post-Traumatic Stress Disorder (PTSD), in North and South Kivu in Eastern DRC. The counselors will be trained and supervised by clinical experts from the NGO Vivo International. The therapy is expected to reduce the symptoms of PTSD, depression, and anxiety in SGBV survivors. The project is expected to directly impact and improve the beneficiaries' mental health outcomes of interest, and to indirectly impact and enhance their economic empowerment in the medium term and social functioning both in the short and medium term. This proposed impact evaluation will answer the following research questions: 1) What is the impact of NET on survivors' psychosocial wellbeing, economic empowerment and social functioning and participation? 2) Does the impact of NET differ depending on individual and household characteristics as well as context-specific factors?

Registry
clinicaltrials.gov
Start Date
June 29, 2017
End Date
February 14, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
World Bank
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • GBV survivors who are screened for commonly found conditions of mental distress

Exclusion Criteria

  • More severe cases of mental disorders are ineligible. They are referred to the General Referral Hospitals or specialized mental health clinics to receive immediate treatment.

Outcomes

Primary Outcomes

Post-traumatic Stress Disorder (PTSD) Severity

Time Frame: Baseline, 3 months follow-up, 12 months follow-up

Change in self-report experience of PTSD symptoms, assessed by using the Harvard Trauma Questionnaire (HTQ-16). This indicator will be constructed as the average PTSD severity score taking the average of the 16 items in HTQ-16 with a range from 0 to 3, where higher scores indicate worse symptoms.

Depression and Anxiety

Time Frame: Baseline, 3 months follow-up, 12 months follow-up

Change in self-report experience of depression and anxiety symptoms, assessed by using the Hopkins Symptom Checklist-25 (HSCL-25). This indicator will be the average of 16 items, ranging from 0 to 3 where higher score indicates greater severity of depression or anxiety.

Secondary Outcomes

  • Total Earnings(Baseline, 3 months follow-up, 12 months follow-up)
  • Labor force participation(Baseline, 3 months follow-up, 12 months follow-up)
  • Saving behavior(Baseline, 3 months follow-up, 12 months follow-up)
  • Sharing of housework(Baseline, 3 months follow-up, 12 months follow-up)
  • Respondent and household asset ownership(Baseline and 12 months follow-up)
  • Self-esteem(Baseline, 3 months follow-up, 12 months follow-up)
  • Management of problems(Baseline, 3 months follow-up, 12 months follow-up)
  • Local functioning impairment index(Baseline, 3 months follow-up, 12 months follow-up)
  • Food insecurity(Baseline, 3 months follow-up, 12 months follow-up)
  • Total amount of savings(Baseline, 3 months follow-up, 12 months follow-up)
  • Decision-making power(Baseline, 3 months follow-up, 12 months follow-up)

Study Sites (2)

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