Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women

Phase 1

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Adapted cognitive behavioral therapy (CBT)

• Registration Number: NCT00353249
• Lead Sponsor: RAND

Brief Summary

This study will determine the effectiveness of cognitive behavioral therapy in treating post-traumatic stress disorder in homeless women.

Detailed Description

Exposure to traumatic events may lead to mental health problems, such as post-traumatic stress disorder (PTSD). PTSD is a type of anxiety disorder that is characterized by the presence of persistent frightening thoughts and memories of the traumatic event. Additionally, people with PTSD often feel emotionally numb, and they may experience sleep problems or be easily startled. Homeless people, in particular, are at risk for experiencing a variety of traumas. Homeless women tend to experience more traumatic events and develop PTSD at higher rates than housed women. Although effective treatments for PTSD are available, homeless women are unlikely to seek them out. There is a need for PTSD treatment approaches that are specifically designed for these women. This study will develop a cognitive-behavioral therapy treatment that will be adapted to best serve the needs of homeless women. The study will then determine the therapy's effectiveness in treating a group of homeless women with PTSD.

This study will consist of three phases. The first phase will be used to gather and analyze information about PTSD in homeless women and methods of treating the disorder in this population. Focus groups consisting of homeless women, shelter directors, case managers, and mental health service providers will be used to obtain the necessary information. Phase two of this study will consist of developing an adaptation of an existing PTSD treatment manual to make it relevant to the lives of homeless women. The third and final phase of this study will recruit 32 homeless women with symptoms of PTSD, and who did not participate in either of the first two phases of the study. Participants in this 4-week study will be randomly assigned to receive either the adapted cognitive behavioral therapy treatment or no treatment at all (assessment-only). The treatment group will attend twice weekly sessions for a total of 4 weeks. All participants will be evaluated immediately prior to the start of treatment and 1 week after treatment ends. Outcomes will include PTSD symptoms and depression symptoms.

Study Timeline

• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Study Start: 2008-06
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• Sub-diagnostic threshold PTSD symptoms
• Currently resides in a transitional homeless shelter in Los Angeles County
• Trauma that is related to PTSD symptoms occurred at least 1 month prior to study entry
• Understands, speaks, and reads English
• Planned departure date from the shelter is at least 1 month after study entry

Exclusion Criteria

• Significant cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adapted cognitive behavioral therapy (CBT)	Participants will receive adapted cognitive behavioral therapy treatment

Primary Outcome Measures

Name	Time	Method
PTSD symptoms	Measured at Week 4
Depression symptoms	Measured at Week 4