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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00607815
Other study ID # MHBA-007-07F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2009
Est. completion date December 27, 2015

Study information

Verified date March 2018
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 27, 2015
Est. primary completion date February 1, 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
United States Cincinnati VA Medical Center, Cincinnati, OH Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinician Administered PTSD Scale 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
Primary PTSD Checklist (PCL) 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 Beck Depression Inventory - II (BDI-II) 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
Secondary State-Trait Anger Scale (STAXI) 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
Secondary State-Trait Anxiety Scale 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
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