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.
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
- Conditions the study is for
- Mental Health Disorder, PTSD, Depression Anxiety Disorder
- What is being tested?
- NET Treatment and Alternative Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Alternative Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 Apr 2021
- Study start29 Jun 2017
- Primary completion14 Feb 2021
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds Social de la République Démocratique du Congo, Vivo international e.V.
- Responsible party
- Sponsor
- Investigators
- Julia Vaillant, PhD, Principal investigator, World Bank
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Economic Impacts of Narrative Exposure Therapy for Violence Survivors in Eastern DRC
- ClinicalTrials.gov ID
- NCT04841031
- Acronym / sponsor ID
- P147489
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Collaborators
- Fonds Social de la République Démocratique du Congo, Vivo international e.V.
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 14 Feb 2021 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NET Treatment | Experimental | Behavioral: NET TreatmentNarrative 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 | Other | Other: Alternative InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GBV survivors who are screened for commonly found conditions of mental distress
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NET TreatmentNarrative 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. | Behavioural | NET Treatment |
| Alternative InterventionIndividuals 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. | Other | Control |
Primary outcome
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.
11 secondary outcomes
Self-esteem
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Management of problems
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Local functioning impairment index
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Labor force participation
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Total Earnings
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Saving behavior
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Total amount of savings
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Decision-making power
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Food insecurity
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Sharing of housework
Time frame: Baseline, 3 months follow-up, 12 months follow-up
Respondent and household asset ownership
Time frame: Baseline and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: Yes. The World Bank has an open data policy, and the de-identified, anonymized data will be published online after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Vaillant, PhD principal investigator
World Bank
2 sites in 1 country: see every site and its status.
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.