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

U

University of Konstanz

Status and phase

Unknown
Phase 1

Conditions

Posttraumatic Stress Disorder
Depression
Prolonged Grief Disorder

Treatments

Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00553956
NET_IPT

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • mental retardation
  • psychotic symptoms
  • current drug or alcohol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

150 participants in 2 patient groups

1
Experimental group
Description:
Intervention group A treatment combination of Narrative Exposure Therapy and Interpersonal Psychotherapy (5 individual sessions NET in addition to 3 individual sessions IPT)
Treatment:
Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy
2
No Intervention group
Description:
Waiting list control

Trial contacts and locations

1

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Central trial contact

Susanne Schaal, Dr.

Data sourced from clinicaltrials.gov

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