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CompletedNCT02989987Updated Oct 1, 2019

NET for SGBV Survivors in Eastern DR Congo

An interventional study of Narrative Exposure Therapy and Social Support in Posttraumatic Stress Disorder and Shame, sponsored by University of Konstanz. Completed at 1 site in Germany. Open to female participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by University of Konstanz · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2016, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
16 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Shame

Keywords

  • PTSD
  • Shame
  • Narrative Exposure Therapy
  • Sexual and gender based violence (SGBV)
  • DR Congo
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In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 201 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Konstanz is the lead sponsor of 48 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • SGBV survivors (event happened more than 4 weeks ago)
  • PTSD diagnosis (DSM-5)

Exclusion criteria

Exclusion Criteria:

  • Acute psychosis
  • Signs of cerebro-organic disease
  • Acute drug or alcohol intoxication
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
201 participants (actual)

Study arms

  • 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

  • Active comparator
    Treatment-as-usual

    Social support (provided on demand)

    Behavioral: Social Support

Interventions

  • BehavioralNarrative Exposure Therapy

    Also known as: NET

  • BehavioralSocial Support

    A local counselors provides social support on demand.

06

What researchers measure

Primary outcomes

  1. PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)

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

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

  2. SVQ: Severity of shame (sumscore)

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

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

Secondary outcomes

  1. ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)

    Shutdown Dissociation Scale (Schalinski et al., 2015)

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

  2. PHQ: Depression symptom severity (sumscore)

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

    Time frame: Change in 3 and 6 months post treatment

  3. Functionality (sumscore)

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

    Time frame: 3 and 6 months post treatment

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Study locations

1 site
  • University of Konstanz
    Konstanz, BW 78464, Germany
08

References and documents

Publications

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

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02989987
Lead sponsor
University of Konstanz
Collaborators
Vivo international e.V.
Responsible party
Anke Köbach (Postdoctoral Researcher, University of Konstanz) — Principal investigator
First posted
Dec 12, 2016
Start date
Sep 2016
Primary completion
Apr 3, 2019
Completion
Apr 3, 2019
Last update
Oct 1, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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