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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353249
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : May 8, 2014
National Institute of Mental Health (NIMH)
Information provided by:

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

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Adapted cognitive behavioral therapy (CBT) Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)
Study Start Date : June 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will receive adapted cognitive behavioral therapy treatment
Behavioral: Adapted cognitive behavioral therapy (CBT)
Adapted CBT is a group treatment for PTSD and will occur two times per week for 4 weeks. The sessions will last 90-minutes and will be led by a therapist and co-therapist.

No Intervention: 2
Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.

Primary Outcome Measures :
  1. PTSD symptoms [ Time Frame: Measured at Week 4 ]
  2. Depression symptoms [ Time Frame: Measured at Week 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00353249

United States, California
Los Angeles County, California, United States
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: Suzanne Wenzel, PhD RAND

Responsible Party: Suzanne Wenzel, RAND Corporation Identifier: NCT00353249     History of Changes
Other Study ID Numbers: R34MH076099 ( U.S. NIH Grant/Contract )
R34MH076099 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014

Keywords provided by RAND:
Cognitive Behavioral Therapy
Homeless Women

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders