NET for SGBV Survivors in Eastern DR Congo

NCT ID: NCT02989987

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-04-03

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder Shame

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Narrative Exposure Therapy

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

Group Type ACTIVE_COMPARATOR

Narrative Exposure Therapy

Intervention Type BEHAVIORAL

Treatment-as-usual

Social support (provided on demand)

Group Type ACTIVE_COMPARATOR

Social Support

Intervention Type BEHAVIORAL

A local counselors provides social support on demand.

Interventions

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Narrative Exposure Therapy

Intervention Type BEHAVIORAL

Social Support

A local counselors provides social support on demand.

Intervention Type BEHAVIORAL

Other Intervention Names

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NET

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vivo international e.V.

INDUSTRY

Sponsor Role collaborator

University of Konstanz

OTHER

Sponsor Role lead

Responsible Party

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Anke Köbach

Postdoctoral Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Konstanz

Konstanz, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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

Reference Type BACKGROUND

Other Identifiers

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SGBV1617

Identifier Type: -

Identifier Source: org_study_id

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