A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide

NCT ID: NCT00553956

Last Updated: 2007-11-06

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-02-28

Brief Summary

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In the framework of the epidemiological study, local psychologists are trained in Butare in carrying out diagnostic interviews with orphans and widows who experienced the Rwandan genocide. With the aid of standardized questionnaires they will assess trauma related symptoms as well as Prolonged Grief Disorder. Under the supervision of clinical experts from the University of Konstanz the local psychologists will carry out a randomized house to house survey (Phase 1).

As a second step, a controlled randomized clinical trial will be carried out. Local psychologists will be trained in applying Narrative Exposure Therapy and Interpersonal Psychotherapy. Genocide survivors that will be identified with a PTSD diagnosis will randomly be assigned to either the treatment condition or a waiting list. The treatment group will receive 5 individual sessions of NET in addition to 3 individual IPT sessions. Subsequent 3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module in alleviating trauma related symptoms and symptoms of prolonged grief. We expect a significant symptom reduction in the experimental group and no significant symptom reduction in the waiting list. After the 6-months post-test, the trained psychologists will train other psychologists in applying this treatment module under the supervision of clinical experts from the University of Konstanz. Afterwards, they will apply therapy to the victims from the waiting list.

A 12-months follow-up will serve to evaluate the long-term effect of the NET/IPT combination.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder Depression Prolonged Grief Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Intervention group A treatment combination of Narrative Exposure Therapy and Interpersonal Psychotherapy (5 individual sessions NET in addition to 3 individual sessions IPT)

Group Type EXPERIMENTAL

Narrative Exposure Therapy/Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.

2

Waiting list control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Narrative Exposure Therapy/Interpersonal Psychotherapy

The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* widows and orphans
* confrontation of the Rwandan genocide
* clinical diagnosis of PTSD

Exclusion Criteria

* mental retardation
* psychotic symptoms
* current drug or alcohol
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University of Konstanz

OTHER

Sponsor Role lead

Principal Investigators

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Susanne Schaal

Role: PRINCIPAL_INVESTIGATOR

University of Konstanz

Locations

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Victims Voice

Butare, Province de Butare, Rwanda

Site Status RECRUITING

Countries

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Rwanda

Central Contacts

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Susanne Schaal, Dr.

Role: CONTACT

Phone: 0049-(0)7531-880

Email: [email protected]

Facility Contacts

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Jean-Pierre Dusingizemungu, Prof.

Role: primary

Other Identifiers

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NET_IPT

Identifier Type: -

Identifier Source: org_study_id