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OpenTrials
Completed

NCT Number: NCT01483261

An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC

To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.

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Key information

Conditions

Post-traumatic Stress Symptoms Psychosocial Distress

Age range

10 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

World Vision Rebound Centre

Beni, South Kivu, Republic of the Congo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Suicidal ideation (irrespective of score on any other measure)

Exclusion criteria

  • psychosis
  • mental retardation
  • inability to understand Swahili
  • one standard deviation below the mean on every measure

Treatment and study plan

Trauma-Focused Cognitive Behavioral Therapy

Behavioral

15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy

Primary outcomes

  1. Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index

    Time frame: baseline, post-intervention and 3-months

Secondary outcomes

  1. Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument

    Time frame: baseline post-intervention and 3-months

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • World Vision

Registry information

Official study title

Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2011
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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