- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607815
A Comparison of Cognitive Processing Therapy (CPT) Versus Present Centered Therapy (PCT) for Veterans
A Comparison of CPT vs PCT for Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related PTSD.
CPT has been shown to be effective in treating trauma survivors in several treatment outcome studies, but utility with Veterans has only been examined with male Veterans in one small pilot study. In addition CPT has never been compared to a treatment as usual or supportive psychotherapy condition to control for the specific and nonspecific elements of treatment. Although Cognitive Processing Therapy is one of the main treatment modalities at several VA's, including Cincinnati, it has never been compared to PCT, nor has it been used in a large, randomized study of male OEF/OIF Veterans. It is hypothesized that individual receiving CPT will show a larger reduction in posttraumatic stress disorder and related symptoms than those individuals receiving PCT.
All male OEF/OIF Veterans will be screened for their appropriateness for the study by phone screen and then by an assessment technician. The Veteran will be assessed at pre, post, 3-month, and 1-year follow-up. The assessment technicians will be blind to the participant's condition. CPT is a 12 week long individual psychotherapy treatment shown to be effective at reducing PTSD and related symptoms for survivors of various types of traumas, including combat. PCT is a supportive counseling treatment that has been utilized as an alternative to waitlist control in VA cooperative studies of PTSD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Cincinnati VA Medical Center, Cincinnati, OH
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PTSD;
- memory of the trauma;
- able to read/write;
- must be stable on medication for 3 months
Exclusion Criteria:
- Psychosis;
- suicidal/homicidal intent;
- alcohol/substance dependence;
- no memory of the trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cognitive Processing Therapy
|
CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
|
|
Active Comparator: Present Centered Therapy
|
Present centered therapy is a supportive counseling model developed by Drs.
Foa and Shea.
The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time.
The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician Administered PTSD Scale
Time Frame: Post-treatment, at 3 months and 1 year
|
Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.
|
Post-treatment, at 3 months and 1 year
|
|
PTSD Checklist (PCL)
Time Frame: post-treatment, at 3 months and 1 year
|
17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed
|
post-treatment, at 3 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory - II (BDI-II)
Time Frame: post-treatment, at 3 months and 1 year
|
Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45.
scale scores are summed.
|
post-treatment, at 3 months and 1 year
|
|
State-Trait Anger Scale (STAXI)
Time Frame: post-treatment, at 3 months and 1 year
|
Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.
|
post-treatment, at 3 months and 1 year
|
|
State-Trait Anxiety Scale
Time Frame: post-treatment, at 3 months and 1 year
|
Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.
|
post-treatment, at 3 months and 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kathleen M Chard, PhD, Cincinnati VA Medical Center, Cincinnati, OH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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