NET for SGBV Survivors in Eastern DR Congo

Study Overview
=================
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.

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

Conditions
-----------------
Posttraumatic Stress Disorder, Shame

Intervention / Treatment
-----------------
* Behavioral: Narrative Exposure Therapy
* Behavioral: Social Support


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narrative Exposure Therapy<br>According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011). | Behavioral: Narrative Exposure Therapy<br> <br> * Other names: NET;|
| Active Comparator: Treatment-as-usual<br>Social support (provided on demand) | Behavioral: Social Support<br>* A local counselors provides social support on demand.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| SVQ: Severity of shame (sumscore) | Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished) | Change from baseline to 3 and 6 months post treatment | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Shame, Narrative Exposure Therapy, Sexual and gender based violence (SGBV), DR Congo