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Clinical Trials/NCT02989987
NCT02989987
Completed
Not Applicable

Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo

University of Konstanz1 site in 1 country201 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
University of Konstanz
Enrollment
201
Locations
1
Primary Endpoint
SVQ: Severity of shame (sumscore)
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
April 3, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Konstanz
Responsible Party
Principal Investigator
Principal Investigator

Anke Köbach

Postdoctoral Researcher

University of Konstanz

Eligibility Criteria

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

Outcomes

Primary Outcomes

SVQ: Severity of shame (sumscore)

Time Frame: Change from baseline to 3 and 6 months post treatment

Shame Variability Questionnaire (Brown, Rizvi \& Linehan, unpublished)

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)

Secondary Outcomes

  • PHQ: Depression symptom severity (sumscore)(Change in 3 and 6 months post treatment)
  • Functionality (sumscore)(3 and 6 months post treatment)
  • ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)(Change from baseline to 3 and 6 months post treatment)

Study Sites (1)

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