NET for SGBV Survivors in Eastern DR Congo

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989987
• Other study ID #: SGBV1617
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Shame
• Stress Disorders, Post-Traumatic

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