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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adapted cognitive behavioral therapy (CBT)
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Cognitive Behavioral Therapy, CBT, Homeless Women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Participants will receive adapted cognitive behavioral therapy treatment

Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.

Outcomes

Primary Outcome Measures

PTSD symptoms
Depression symptoms

Secondary Outcome Measures

Full Information

First Posted
July 14, 2006
Last Updated
May 6, 2014
Sponsor
RAND
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00353249
Brief Title
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women
Official Title
Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
RAND
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Cognitive Behavioral Therapy, CBT, Homeless Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive adapted cognitive behavioral therapy treatment
Arm Title
2
Arm Type
No Intervention
Arm Description
Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.
Intervention Type
Behavioral
Intervention Name(s)
Adapted cognitive behavioral therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptoms
Time Frame
Measured at Week 4
Title
Depression symptoms
Time Frame
Measured at Week 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Wenzel, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
City
Los Angeles County
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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