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

Not Applicable

Completed

• Conditions: Mental Health Disorder; PTSD; Depression Anxiety Disorder; Gender-based Violence
• Interventions: Behavioral: NET Treatment; Other: Alternative Intervention

• Registration Number: NCT04841031
• Lead Sponsor: World Bank

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2020-05-07
• Primary Completion: 2021-02-14
• Study Completion: 2021-02-14
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1053

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NET Treatment	NET Treatment	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.
Control	Alternative Intervention	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.

Primary Outcome Measures

Name	Time	Method
Post-traumatic Stress Disorder (PTSD) Severity	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	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 Outcome Measures

Name	Time	Method
Total Earnings	Baseline, 3 months follow-up, 12 months follow-up	Change in the respondent's total earnings in the last 30 days (in main and secondary activities) in USD. This indicator will be the sum of the respondent's earnings from her main and secondary activities in the last 30 days.
Labor force participation	Baseline, 3 months follow-up, 12 months follow-up	Changes in the participation of respondents in income generating activities in the last 7 days. This indicator will be constructed as binary variable equal to 1 if the respondent reported any kind of work in the last 7 days, such as paid in-kind, unpaid, self-employment, non-farm family business or family farm.
Saving behavior	Baseline, 3 months follow-up, 12 months follow-up	Changes in the number of participants who saved in the last 6 or 12 months.
Sharing of housework	Baseline, 3 months follow-up, 12 months follow-up	Changes in the average score of the level of the participation of the respondent's partner in the domestic tasks. We will create this indicator as the average score of the level of the participation of the respondent's partner in the tasks of cooking and laundry-cleaning. First, we will score the partner's participation per task. Then we will create the index by taking the average score over the two tasks. The index will have a range of \[0-3\] with higher scores indicating more participation of the partner.
Respondent and household asset ownership	Baseline and 12 months follow-up	Changes in the number of items owned by the respondent and the household
Self-esteem	Baseline, 3 months follow-up, 12 months follow-up	Change in self-reported measure of self-esteem, assessed using Rosenberg Self-Esteem Scale with 10 items that are rated on a 4-point Likert Scale (minimum value:0 and maximum value:3). After reversing the negative items, the self-esteem index will be constructed as the average of the per-item scores, higher scores indicating higher self-esteem.
Management of problems	Baseline, 3 months follow-up, 12 months follow-up	Change in self-reported measure of management of problems in certain activities when they feel bad, such as talking to friends, family, other women with similar things, praying, working, locking herself in the house, drinking alcohol, singing, spending time with others. . After reversing the negative items, the index for management of problems will be constructed by taking the average of the values of the 8 items. The items are rated on a 4-point Likert Scale, with item values ranging from "0=Not at all/Never" to "3=Often". Higher scores will indicate improved management of problems (minimum value:0 and maximum value:3).
Local functioning impairment index	Baseline, 3 months follow-up, 12 months follow-up	Change in self-reported experience of difficulties in performing certain activities, specifically to what extent they are experiencing difficulties in performing activities, such as farming, income generating activities, housework, socializing with family and community members, focusing on their tasks and responsibilities, cooking, taking care of children, exchange ideas, do any type of manual work, receive help, make important decisions, learn new skills, and interact with people they don't know in the last 4 weeks. The local functioning impairment index will be created by taking the average of 14 item scores rated on a 5-point Likert scale with values ranging from "0=No difficulty" to "4=So difficult that she couldn't do it". Higher scores will indicate greater impairment in local functioning (minimum value:0 and maximum value:4)
Food insecurity	Baseline, 3 months follow-up, 12 months follow-up	Changes in the number of average number of meals that the members of the respondent's household had to skip in the past 7 days, conditional on anyone in the household having to skip meal because there was not enough food.
Total amount of savings	Baseline, 3 months follow-up, 12 months follow-up	Changes in the total amount of savings (formal or informal) in the last 6 or 12 months.
Decision-making power	Baseline, 3 months follow-up, 12 months follow-up	Changes in the power of decision of the participant. We will create a power of decision index capturing the respondent's weight in making decisions regarding 1) her own income, 2) pregnancy, 3) children's education, 4) her own health care, 5) household money, 6) major purchases, and 7) visits to her family. We will construct the index by taking the mean of the items, where a higher score indicates more power of decision making. The range is \[0-2\].

Trial Locations

Locations (2)

North Kivu; 🇨🇩 Goma, Congo, The Democratic Republic of the

South Kivu; 🇨🇩 Bukavu, Congo, The Democratic Republic of the