NET for SGBV Survivors in Eastern DR Congo
Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
1 other identifier
interventional
201
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2019
CompletedOctober 1, 2019
September 1, 2019
2.6 years
December 6, 2016
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
PTSD Symptom Scale - Interview (PSS-I; Foa \& Tolin, 2000)
Change from baseline to 3 and 6 months post treatment
SVQ: Severity of shame (sumscore)
Shame Variability Questionnaire (Brown, Rizvi \& Linehan, unpublished)
Change from baseline to 3 and 6 months post treatment
Secondary Outcomes (3)
ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
Change from baseline to 3 and 6 months post treatment
PHQ: Depression symptom severity (sumscore)
Change in 3 and 6 months post treatment
Functionality (sumscore)
3 and 6 months post treatment
Study Arms (2)
Narrative Exposure Therapy
ACTIVE COMPARATORAccording to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).
Treatment-as-usual
ACTIVE COMPARATORSocial support (provided on demand)
Interventions
Eligibility Criteria
You may qualify if:
- SGBV survivors (event happened more than 4 weeks ago)
- PTSD diagnosis (DSM-5)
You may not qualify if:
- Acute psychosis
- Signs of cerebro-organic disease
- Acute drug or alcohol intoxication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Konstanzlead
- Vivo international e.V.collaborator
Study Sites (1)
University of Konstanz
Konstanz, Baden-Wurttemberg, 78464, Germany
Related Publications (1)
Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Researcher
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 12, 2016
Study Start
September 1, 2016
Primary Completion
April 3, 2019
Study Completion
April 3, 2019
Last Updated
October 1, 2019
Record last verified: 2019-09