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Mental Health DisorderNCT04841031

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

A study testing NET Treatment and Alternative Intervention in people with Mental Health Disorder and PTSD, run by World Bank at 2 sites in Democratic Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
NET Treatment and Alternative Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,053 participants
Where
2 sitesDemocratic Republic of the Congo
Study dates
29 Jun 2017to 14 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Democratic Republic of the Congo2 sites
  • South Kivu

    Bukavu

  • North Kivu

    Goma

Other trials in Democratic Republic of the Congo

About this study

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?

Being tested
NET Treatment, Alternative Intervention
Medical subject headings
Mental Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NET TreatmentBehavioural

    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.

  • Alternative InterventionOther

    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.

Study groups in NCT04841031
Study groupRoleWhat they receive
NET TreatmentExperimentalNarrative 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.
Receives: Behavioral: NET Treatment
ControlOtherThis 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.
Receives: Other: Alternative Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (11)
  1. Self-esteem

    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.

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

  2. Management of problems

    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).

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

  3. Local functioning impairment index

    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)

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

  4. Labor force participation

    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.

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

  5. Total Earnings

    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.

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

  6. Saving behavior

    Changes in the number of participants who saved in the last 6 or 12 months.

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

  7. Total amount of savings

    Changes in the total amount of savings (formal or informal) in the last 6 or 12 months.

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

  8. Decision-making power

    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].

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

  9. Food insecurity

    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.

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

  10. Sharing of housework

    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.

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

  11. Respondent and household asset ownership

    Changes in the number of items owned by the respondent and the household

    Measured: Baseline and 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2021
  2. Study start29 Jun 2017
  3. Primary completion14 Feb 2021
  4. Study completion14 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04841031
Sponsor's protocol ID
P147489
Status last verified
Apr 2021
First submitted
7 May 2020
Last updated
12 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The World Bank has an open data policy, and the de-identified, anonymized data will be published online after the study is completed.

Questions about this trial

What is this clinical trial studying?

A study testing NET Treatment and Alternative Intervention in people with Mental Health Disorder and PTSD, run by World Bank at 2 sites in Democratic Republic of the Congo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-traumatic Stress Disorder (PTSD) Severity (time frame: Baseline, 3 months follow-up, 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.

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