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

Sponsor
RAND (Other)
Overall Status
Completed
CT.gov ID
NCT00353249
Collaborator
National Institute of Mental Health (NIMH) (NIH)
31
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Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 2008
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. PTSD symptoms [Measured at Week 4]

  2. Depression symptoms [Measured at Week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Los Angeles County California United States

Sponsors and Collaborators

  • RAND
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Suzanne Wenzel, PhD, RAND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00353249
Other Study ID Numbers:
  • R34MH076099
  • R34MH076099
  • DSIR 82-SEMS
First Posted:
Jul 18, 2006
Last Update Posted:
May 8, 2014
Last Verified:
May 1, 2014

Study Results

No Results Posted as of May 8, 2014