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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00353249 |
This study will determine the effectiveness of cognitive behavioral therapy in treating post-traumatic stress disorder in homeless women.
Condition | Intervention | Phase |
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Post-Traumatic Stress Disorder |
Behavioral: Adapted cognitive behavioral therapy (CBT) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD) |
Estimated Enrollment: | 32 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive adapted cognitive behavioral therapy treatment
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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.
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2: No Intervention
Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nadine R. Rayburn, PhD | 310-393-0411 | rayburn@rand.org |
Contact: Suzanne Wenzel, PhD | 310-393-0411 ext 6415 | suzanne_wenzel@rand.org |
United States, California | |
Recruiting | |
Los Angeles County, California, United States |
Principal Investigator: | Suzanne Wenzel, PhD | RAND Corporation |
Responsible Party: | RAND Corporation ( Suzanne Wenzel ) |
Study ID Numbers: | R34 MH76099, DSIR 82-SEMS |
Study First Received: | July 14, 2006 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00353249 |
Health Authority: | United States: Federal Government |
Cognitive Behavioral Therapy CBT Homeless Women |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease |