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Sponsors and Collaborators: |
Center for Trauma Recovery, St Louis National Institute of Mental Health (NIMH) |
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Information provided by: | Center for Trauma Recovery, St Louis |
ClinicalTrials.gov Identifier: | NCT00630578 |
This proposal seeks to increase the effectiveness of an existing treatment strategy, cognitive processing therapy (CPT), for the remediation of Posttraumatic Stress Disorder among crime victims by varying the duration and content of the intervention in accordance with participants' needs. A secondary goal is to identify predictors of duration of treatment necessary to achieve good end state functioning, including individual and trauma variables, cognitive and emotional variables, and Axis II pathology. Finally, by including a sample of male participants, the generalizability of CPT will be tested. It is anticipated that these modifications will speed the dissemination of CPT to community practice thus benefiting more trauma victims. Fifty subjects will be randomly assigned to either the modified CPT condition or to a symptom-monitoring, minimal attention condition designed to control for the effects of the daily monitoring and the passage of time. Utilizing a semicrossover design, the control condition will be crossed over to the active treatment, allowing for a replication within the study. The entire treated sample (N = 50) will be compared to a sample (N = 50) receiving strict 12-session protocol-driven CPT through the course of a recent study conducted at the same site using the same primary outcome measures. Conducting the proposed study will have important implications on advancing the ecological validity and effectiveness of applied research on PTSD.
Condition | Intervention |
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Posttraumatic Stress Disorder |
Behavioral: Cognitive Processing Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Efficacy Study |
Official Title: | Improving Effectiveness: Treatment Outcome Research |
Estimated Enrollment: | 50 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Cognitive Processing Therapy
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Behavioral: Cognitive Processing Therapy
Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.
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2: No Intervention
Arm 2 participants will monitor their symptoms for a period of 10 weeks, prior to being crossed over into active treatment. This will allow investigators to account for the passage of time without intervention when tracking symptoms.
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Behavioral: Cognitive Processing Therapy
Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Juliette Mott, MA | 314-516-6737 | juliettemott@umsl.edu |
United States, Missouri | |
Center for Trauma Recovery | Recruiting |
St. Louis, Missouri, United States, 63121 | |
Principal Investigator: Tara Galovski, PhD |
Principal Investigator: | Tara Galovski, PhD | Center for Trauma Recovery, University of Missouri- St. Louis |
Responsible Party: | University of Missouri- St. Louis ( Tara Galovski ) |
Study ID Numbers: | 1R34MH074937-01A2 |
Study First Received: | February 28, 2008 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00630578 |
Health Authority: | United States: Institutional Review Board |
PTSD Posttraumatic Stress Disorder Physical Assault Physical Abuse |
Sexual Assault Sexual Abuse Interpersonal Assault Cognitive Processing Therapy |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |