NET for SGBV Survivors in Eastern DR Congo
September 30, 2019 updated by: Anke Köbach, University of Konstanz
Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions.
In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.
Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures PTSD and shame.
The trial will take place in Goma, DR Congo, where SGBV and its sequelae has been a major problem.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will be recruited through local NGOs and eligible clients randomized to the treatment (NET; app.
N=100) or treatment-as-usual control (app.
N=100) group, respectively.
At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure - esp.
SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a structured interview.
The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BW
-
Konstanz, BW, Germany, 78464
- University of Konstanz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- SGBV survivors (event happened more than 4 weeks ago)
- PTSD diagnosis (DSM-5)
Exclusion Criteria:
- Acute psychosis
- Signs of cerebro-organic disease
- Acute drug or alcohol intoxication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Narrative Exposure Therapy
According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).
|
Other Names:
|
|
Active Comparator: Treatment-as-usual
Social support (provided on demand)
|
A local counselors provides social support on demand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
Time Frame: Change from baseline to 3 and 6 months post treatment
|
PTSD Symptom Scale - Interview (PSS-I; Foa & Tolin, 2000)
|
Change from baseline to 3 and 6 months post treatment
|
|
SVQ: Severity of shame (sumscore)
Time Frame: Change from baseline to 3 and 6 months post treatment
|
Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished)
|
Change from baseline to 3 and 6 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
Time Frame: Change from baseline to 3 and 6 months post treatment
|
Shutdown Dissociation Scale (Schalinski et al., 2015)
|
Change from baseline to 3 and 6 months post treatment
|
|
PHQ: Depression symptom severity (sumscore)
Time Frame: Change in 3 and 6 months post treatment
|
Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002)
|
Change in 3 and 6 months post treatment
|
|
Functionality (sumscore)
Time Frame: 3 and 6 months post treatment
|
Local Functionality Index (LFI; Bass et al., 2013)
|
3 and 6 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
April 3, 2019
Study Completion (Actual)
April 3, 2019
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimate)
December 12, 2016
Study Record Updates
Last Update Posted (Actual)
October 1, 2019
Last Update Submitted That Met QC Criteria
September 30, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGBV1617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.