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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02989987
Other study ID # SGBV1617
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date April 3, 2019

Study information

Verified date September 2019
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date April 3, 2019
Est. primary completion date April 3, 2019
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 80 Years
Eligibility 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 Design


Intervention

Behavioral:
Narrative Exposure Therapy

Social Support
A local counselors provides social support on demand.

Locations

Country Name City State
Germany University of Konstanz Konstanz BW

Sponsors (2)

Lead Sponsor Collaborator
University of Konstanz Vivo international e.V.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis) PTSD Symptom Scale - Interview (PSS-I; Foa & Tolin, 2000) Change from baseline to 3 and 6 months post treatment
Primary SVQ: Severity of shame (sumscore) Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished) Change from baseline to 3 and 6 months post treatment
Secondary ShutD: Severity of Shutdown Dissociation Symptoms (sumscore) Shutdown Dissociation Scale (Schalinski et al., 2015) Change from baseline to 3 and 6 months post treatment
Secondary PHQ: Depression symptom severity (sumscore) Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002) Change in 3 and 6 months post treatment
Secondary Functionality (sumscore) Local Functionality Index (LFI; Bass et al., 2013) 3 and 6 months post treatment
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