NCT00353249

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

July 14, 2006

Last Update Submit

May 6, 2014

Conditions

Post-Traumatic Stress Disorder

Keywords

Cognitive Behavioral TherapyCBTHomeless Women

Outcome Measures

Primary Outcomes (2)

  • PTSD symptoms

    Measured at Week 4

  • Depression symptoms

    Measured at Week 4

Study Arms (2)

1

EXPERIMENTAL

Participants will receive adapted cognitive behavioral therapy treatment

Behavioral: Adapted cognitive behavioral therapy (CBT)

2

NO INTERVENTION

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

Interventions

Adapted cognitive behavioral therapy (CBT)BEHAVIORAL

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.

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Los Angeles County, California, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Suzanne Wenzel, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 18, 2006

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

US(1)