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NET for SGBV Survivors in Eastern DR Congo

Primary Purpose

Posttraumatic Stress Disorder, Shame

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Social Support
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Shame, Narrative Exposure Therapy, Sexual and gender based violence (SGBV), DR Congo

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Konstanz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Narrative Exposure Therapy

Treatment-as-usual

Arm Description

According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).

Social support (provided on demand)

Outcomes

Primary Outcome Measures

PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
PTSD Symptom Scale - Interview (PSS-I; Foa & Tolin, 2000)
SVQ: Severity of shame (sumscore)
Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished)

Secondary Outcome Measures

ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
Shutdown Dissociation Scale (Schalinski et al., 2015)
PHQ: Depression symptom severity (sumscore)
Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002)
Functionality (sumscore)
Local Functionality Index (LFI; Bass et al., 2013)

Full Information

First Posted
December 6, 2016
Last Updated
September 30, 2019
Sponsor
University of Konstanz
Collaborators
Vivo international e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02989987
Brief Title
NET for SGBV Survivors in Eastern DR Congo
Official Title
Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Vivo international e.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Shame
Keywords
PTSD, Shame, Narrative Exposure Therapy, Sexual and gender based violence (SGBV), DR Congo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative Exposure Therapy
Arm Type
Active Comparator
Arm Description
According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).
Arm Title
Treatment-as-usual
Arm Type
Active Comparator
Arm Description
Social support (provided on demand)
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Type
Behavioral
Intervention Name(s)
Social Support
Intervention Description
A local counselors provides social support on demand.
Primary Outcome Measure Information:
Title
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
Description
PTSD Symptom Scale - Interview (PSS-I; Foa & Tolin, 2000)
Time Frame
Change from baseline to 3 and 6 months post treatment
Title
SVQ: Severity of shame (sumscore)
Description
Shame Variability Questionnaire (Brown, Rizvi & Linehan, unpublished)
Time Frame
Change from baseline to 3 and 6 months post treatment
Secondary Outcome Measure Information:
Title
ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
Description
Shutdown Dissociation Scale (Schalinski et al., 2015)
Time Frame
Change from baseline to 3 and 6 months post treatment
Title
PHQ: Depression symptom severity (sumscore)
Description
Patient Health Questionnaire - 9 (PHQ-9; Kroenke & Spitzer, 2002)
Time Frame
Change in 3 and 6 months post treatment
Title
Functionality (sumscore)
Description
Local Functionality Index (LFI; Bass et al., 2013)
Time Frame
3 and 6 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Konstanz
City
Konstanz
State/Province
BW
ZIP/Postal Code
78464
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
Results Reference
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NET for SGBV Survivors in Eastern DR Congo

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