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

NCT04841031 | Completed

• 1 other identifier: P147489
• Study Type: interventional
• Target: 1,053
• Locations: 1 country
• Sites: 2

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?

Conditions

Mental Health Disorder; PTSD; Depression Anxiety Disorder; Gender-based Violence

Outcome Measures

Primary Outcomes (2)

• Post-traumatic Stress Disorder (PTSD) Severity

  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.

  Baseline, 3 months follow-up, 12 months follow-up

• Depression and Anxiety

  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.

  Baseline, 3 months follow-up, 12 months follow-up

Secondary Outcomes (11)

• 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

• Labor force participation

  Baseline, 3 months follow-up, 12 months follow-up

• Total Earnings

  Baseline, 3 months follow-up, 12 months follow-up

Study Arms (2)

NET Treatment

EXPERIMENTAL

Narrative Exposure Therapy (NET) Treatment: Treatment group consists of eligible individuals who are randomly assigned to receive NET treatment and are part of the study sample. Within each health center, treated individuals are randomly selected over several cohorts. In every cohort, the treatment group contained 6 individuals who received NET.

Behavioral: NET Treatment

Control

OTHER

This group contains eligible individuals who are randomly assigned to the control group and are part of the study sample. In every cohort, the control group contained 6 individuals.

Other: Alternative Intervention

Interventions

NET Treatment BEHAVIORAL

Narrative Exposure Therapy (NET) aims to address PTSD symptoms among survivors of mass violence and torture (Onyut et al., 2004; Schauer, et al., 2005). Mainly, different from other psychosocial interventions which require the survivor to process a single traumatic event in his or her life at a given time, NET treatment recognizes that trauma survivors undergo multiple distressing events within their lifetime (Schauer et al., 2005). Focusing on the traumatic events, the patient constructs a chronological narrative of his or her life story and a coherent narrative is then structured with the assistance of the therapist. They received NET one to three months following their screening and randomization. The therapy involves 8 to 12 individual sessions of about 90 minutes each.

NET Treatment

Alternative Intervention OTHER

Individuals in control group received non-NET psychosocial support in the interim that is provided to SGBV survivors as part of the Great Lakes SGBV project and will then receive NET after endline data has been collected.

Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• World Bank: lead
• Fonds Social de la République Démocratique du Congo: collaborator
• Vivo international e.V.: collaborator

Study Sites (2)

South Kivu

Bukavu, Democratic Republic of the Congo

Location

North Kivu

Goma, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Mental Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Julia Vaillant, PhD

  World Bank

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: April 12, 2021
• Study Start: June 29, 2017
• Primary Completion: February 14, 2021
• Study Completion: February 14, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)