Los Angeles County, California, United States
NCT Number: NCT00353249
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women
This study will determine the effectiveness of cognitive behavioral therapy in treating post-traumatic stress disorder in homeless women.
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Adapted cognitive behavioral therapy (CBT)
BehavioralAdapted 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.
Primary outcomes
-
PTSD symptoms
Time frame: Measured at Week 4
-
Depression symptoms
Time frame: Measured at Week 4
Sponsors and collaborators
Lead sponsor
RAND
Other
Collaborators
- National Institute of Mental Health (NIMH)
Registry information
Official study title
Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)
Important dates
- Study start
- 2008
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jul 18, 2006
- Registry last updated
- May 8, 2014
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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