NET for SGBV Survivors in Eastern DR Congo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02989987
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : November 6, 2017
Vivo international e.V.
Information provided by (Responsible Party):
Anke Köbach, University of Konstanz

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
Posttraumatic Stress Disorder Shame Behavioral: Narrative Exposure Therapy Behavioral: Social Support Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 160 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
Study Start Date : September 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: NET
Active Comparator: Treatment-as-usual
Social support (provided on demand)
Behavioral: Social Support
A local counselors provides social support on demand.

Primary Outcome Measures :
  1. 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)

  2. SVQ: Severity of shame (sumscore) [ Time Frame: 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) [ Time Frame: Change from baseline to 3 and 6 months post treatment ]
    Shutdown Dissociation Scale (Schalinski et al., 2015)

  2. PHQ: Depression symptom severity (sumscore) [ Time Frame: Change in 3 and 6 months post treatment ]
    Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002)

  3. Functionality (sumscore) [ Time Frame: 3 and 6 months post treatment ]
    Local Functionality Index (LFI; Bass et al., 2013)

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02989987

Contact: Anke Köbach

University of Konstanz Recruiting
Konstanz, BW, Germany, 78464
Contact: Anke Koebach, Dr.    07531884626   
Sponsors and Collaborators
University of Konstanz
Vivo international e.V.

Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.

Responsible Party: Anke Köbach, Postdoctoral Researcher, University of Konstanz Identifier: NCT02989987     History of Changes
Other Study ID Numbers: SGBV1617
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anke Köbach, University of Konstanz:
Narrative Exposure Therapy
Sexual and gender based violence (SGBV)
DR Congo

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders