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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353249
• Other study ID #: R34MH076099
• Secondary ID: R34MH076099DSIR
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2006
• Last updated: May 6, 2014
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2014
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
RAND	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms		Measured at Week 4	No
Primary	Depression symptoms		Measured at Week 4	No