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A Comparison of Cognitive Processing Therapy (CPT) Versus Present Centered Therapy (PCT) for Veterans

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607815
First Posted: February 6, 2008
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
PTSD Behavioral: Cognitive Processing Therapy Behavioral: Present Centered Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of CPT vs PCT for Veterans

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.

  • 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


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.


Enrollment: 79
Actual Study Start Date: June 15, 2009
Estimated Study Completion Date: December 27, 2017
Primary Completion Date: February 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Processing Therapy
Cognitive Processing Therapy
Behavioral: 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
Behavioral: 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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be a male combat Veteran
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607815


Locations
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kathleen M Chard, PhD Cincinnati VA Medical Center, Cincinnati, OH
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00607815     History of Changes
Other Study ID Numbers: MHBA-007-07F
First Submitted: February 4, 2008
First Posted: February 6, 2008
Results First Submitted: February 27, 2015
Results First Posted: July 20, 2015
Last Update Posted: September 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
OEF/OIF
Combat
Treatment
CPT
PCT
Cognitive