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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
RAND
ClinicalTrials.gov Identifier:
NCT00353249
First received: July 14, 2006
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353249

Locations
United States, California
Los Angeles County, California, United States
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Suzanne Wenzel, PhD RAND Corporation
  More Information

No publications provided

Responsible Party: Suzanne Wenzel, RAND Corporation
ClinicalTrials.gov Identifier: NCT00353249     History of Changes
Other Study ID Numbers: R34 MH076099, R34MH076099, DSIR 82-SEMS
Study First Received: July 14, 2006
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Keywords provided by RAND:
Cognitive Behavioral Therapy
CBT
Homeless Women

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014