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

Post-traumatic Stress Symptoms Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483261
• Other study ID #: PREC23-2011
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2011
• Last updated: December 1, 2011
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-traumatic Stress Symptoms
• Psychosocial Distress

Intervention

Behavioral:
• Trauma-Focused Cognitive Behavioral Therapy
15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy

Locations

Country	Name	City	State
Congo	World Vision Rebound Centre	Beni	South Kivu

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	World Vision

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index		baseline, post-intervention and 3-months	No
Secondary	Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument		baseline post-intervention and 3-months	No