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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00353249
First received: July 14, 2006
Last updated: April 10, 2009
Last verified: April 2009
History of Changes

July 14, 2006
April 10, 2009
June 2008
October 2008   (final data collection date for primary outcome measure)
  • PTSD symptoms [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]
  • Depression symptoms [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]
  • PTSD symptoms
  • Depression symptoms (both measured at Week 7)
Complete list of historical versions of study NCT00353249 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women
Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
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.
  • Experimental: 1
    Participants will receive adapted cognitive behavioral therapy treatment
    Intervention: Behavioral: Adapted cognitive behavioral therapy (CBT)
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2008
October 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00353249
R34 MH076099, DSIR 82-SEMS
 
Suzanne Wenzel, RAND Corporation
National Institute of Mental Health (NIMH)
 
Principal Investigator: Suzanne Wenzel, PhD RAND Corporation
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP