NCT00623298

Brief Summary

The present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the treatment-induced changes. We hypothesized that there would be a greater reduction in posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be superior to NET in the reduction of depression symptoms.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
Last Updated

February 26, 2008

Status Verified

February 1, 2008

First QC Date

February 14, 2008

Last Update Submit

February 25, 2008

Conditions

Posttraumatic Stress DisorderDepressionNarrative Exposure TherapyInterpersonal Psychotherapy

Keywords

Posttraumatic stress disorderdepressionNarrative Exposure TherapyInterpersonal Psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Symptoms of posttraumatic stress disorder, symptoms of depression

Study Arms (3)

1

EXPERIMENTAL

NET

Behavioral: Narrative Exposure Therapy

3

NO INTERVENTION

6-months baseline

Other: 6 months-baseline

2

EXPERIMENTAL

group IPT

Behavioral: group IPT

Interventions

Narrative Exposure TherapyBEHAVIORAL
1
group IPTBEHAVIORAL
2
6 months-baselineOTHER
3

Eligibility Criteria

Age13 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Rwandan orphans who have experienced the genocide, who lost at least one parent during the genocide and who were no older than 18 years during the genocide

You may not qualify if:

  • Mental retardation
  • Psychotic symptoms or current drug or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 26, 2008

Study Start

January 1, 2005

Study Completion

March 1, 2006

Last Updated

February 26, 2008

Record last verified: 2008-02