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

  • Germany
    • 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).
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.

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

University of Konstanz

Collaborators

Vivo international e.V.

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

Keywords

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.

Clinical Trials on Posttraumatic Stress Disorder

Clinical Trials on Narrative Exposure Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe