NCT00607815

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 15, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 20, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2015

Completed
Last Updated

June 26, 2018

Status Verified

March 1, 2018

Enrollment Period

5.6 years

First QC Date

February 4, 2008

Results QC Date

February 27, 2015

Last Update Submit

March 27, 2018

Conditions

PTSD

Keywords

PTSDOEF/OIFCombatTreatmentCPTPCTCognitive

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Beck Depression Inventory - II (BDI-II)

    post-treatment, at 3 months and 1 year

  • State-Trait Anger Scale (STAXI)

    post-treatment, at 3 months and 1 year

  • State-Trait Anxiety Scale

    post-treatment, at 3 months and 1 year

Study Arms (2)

Cognitive Processing Therapy

ACTIVE COMPARATOR

Cognitive Processing Therapy

Behavioral: Cognitive Processing Therapy

Present Centered Therapy

ACTIVE COMPARATOR

Present Centered Therapy

Behavioral: Present Centered Therapy

Interventions

Cognitive Processing TherapyBEHAVIORAL

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.

Cognitive Processing Therapy
Present Centered TherapyBEHAVIORAL

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

Present Centered Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMust be a male combat Veteran
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PTSD;
  • memory of the trauma;
  • able to read/write;
  • must be stable on medication for 3 months

You may not qualify if:

  • Psychosis;
  • suicidal/homicidal intent;
  • alcohol/substance dependence;
  • no memory of the trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

Significant amounts of missing data from patients not attending assessment. Drop out rate from treatment was higher than other clinical trials of CPT and PCT in civilian samples, but in keeping with other studies of Veterans.

Results Point of Contact

Title
Dr. Kathleen M. Chard
Organization
Cincinnati VA Medical Center
Kathleen.Chard@va.gov
859-572-6741

Study Officials

  • Kathleen M Chard, PhD

    Cincinnati VA Medical Center, Cincinnati, OH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 6, 2008

Study Start

June 15, 2009

Primary Completion

February 1, 2015

Study Completion

December 27, 2015

Last Updated

June 26, 2018

Results First Posted

July 20, 2015

Record last verified: 2018-03

Locations

US(1)