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

NCT00553956 | Unknown Phase 1

• 1 other identifier: NET_IPT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Depression; Prolonged Grief Disorder

Outcome Measures

Primary Outcomes (1)

• Symptoms of PTSD, depression, prolonged grief disorder

  12 months

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy

2

NO INTERVENTION

Waiting list control

Interventions

Narrative Exposure Therapy/Interpersonal Psychotherapy BEHAVIORAL

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

1

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• mental retardation
• psychotic symptoms
• current drug or alcohol

Sponsors & Collaborators

• University of Konstanz: lead
• German Research Foundation: collaborator

Study Sites (1)

Victims Voice

Butare, Province de Butare, 57645, Rwanda

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Prolonged Grief Disorder

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susanne Schaal

  University of Konstanz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Schaal, Dr.

CONTACT

0049-(0)7531-880; Susanne.Schaal@gmx.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: August 1, 2007
• Study Completion: February 1, 2009
• Last Updated: November 6, 2007

Record last verified: 2007-11

Locations

RW (1)