NET for SGBV Survivors in Eastern DR Congo

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Shame
• Interventions: Behavioral: Narrative Exposure Therapy; Behavioral: Social Support

• Registration Number: NCT02989987
• Lead Sponsor: University of Konstanz

Brief 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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-12
• Primary Completion: 2019-04-03
• Study Completion: 2019-04-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narrative Exposure Therapy	Narrative Exposure Therapy	According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).
Treatment-as-usual	Social Support	Social support (provided on demand)

Primary Outcome Measures

Name	Time	Method
SVQ: Severity of shame (sumscore)	Change from baseline to 3 and 6 months post treatment	Shame Variability Questionnaire (Brown, Rizvi \& Linehan, unpublished)
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)	Change from baseline to 3 and 6 months post treatment	PTSD Symptom Scale - Interview (PSS-I; Foa \& Tolin, 2000)

Secondary Outcome Measures

Name	Time	Method
PHQ: Depression symptom severity (sumscore)	Change in 3 and 6 months post treatment	Patient Health Questionnaire - 9 (PHQ-9; Kroenke \& Spitzer, 2002)
Functionality (sumscore)	3 and 6 months post treatment	Local Functionality Index (LFI; Bass et al., 2013)
ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)	Change from baseline to 3 and 6 months post treatment	Shutdown Dissociation Scale (Schalinski et al., 2015)

Trial Locations

Locations (1)

University of Konstanz; 🇩🇪 Konstanz, BW, Germany