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NET for SGBV Survivors in Eastern DR Congo

Sponsor
University of Konstanz (Other)
Overall Status
Completed
CT.gov ID
NCT02989987
Collaborator
Vivo international e.V. (Industry)
201
Enrollment
1
Location
2
Arms
31
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Narrative Exposure Therapy
  • Behavioral: Social Support
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Apr 3, 2019
Actual Study Completion Date :
Apr 3, 2019

Arms and Interventions

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).

Behavioral: Narrative Exposure Therapy
Other Names:
  • NET

    		•
    Active Comparator: Treatment-as-usual

    Social support (provided on demand)

    Behavioral: Social Support
    A local counselors provides social support on demand.

    Outcome Measures

    Primary Outcome Measures

    1. PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis) [Change from baseline to 3 and 6 months post treatment]

      PTSD Symptom Scale - Interview (PSS-I; Foa & Tolin, 2000)

    2. SVQ: Severity of shame (sumscore) [Change from baseline to 3 and 6 months post treatment]

      Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished)

    Secondary Outcome Measures

    1. ShutD: Severity of Shutdown Dissociation Symptoms (sumscore) [Change from baseline to 3 and 6 months post treatment]

      Shutdown Dissociation Scale (Schalinski et al., 2015)

    2. PHQ: Depression symptom severity (sumscore) [Change in 3 and 6 months post treatment]

      Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002)

    3. Functionality (sumscore) [3 and 6 months post treatment]

      Local Functionality Index (LFI; Bass et al., 2013)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Konstanz Konstanz BW Germany 78464

    Sponsors and Collaborators

    • University of Konstanz
    • Vivo international e.V.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Anke Köbach, Postdoctoral Researcher, University of Konstanz
    ClinicalTrials.gov Identifier:
    NCT02989987
    Other Study ID Numbers:
    • SGBV1617
    First Posted:
    Dec 12, 2016
    Last Update Posted:
    Oct 1, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Anke Köbach, Postdoctoral Researcher, University of Konstanz
    PTSD
    Shame
    Narrative Exposure Therapy
    Sexual and gender based violence (SGBV)
    DR Congo
    Additional relevant MeSH terms:
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Oct 1, 2019