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Completed

NCT Number: NCT02989987

NET for SGBV Survivors 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.

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Key information

Conditions

Posttraumatic Stress Disorder Behavior Coitus Mental Disorders Sexual Behavior Shame Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

16 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Exposure Therapy

Behavioral

Other names: NET

Social Support

Behavioral

A local counselors provides social support on demand.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Collaborators

  • Vivo international e.V.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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