NCT02313818

Brief Summary

The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

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

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 16, 2019

Status Verified

December 1, 2018

Enrollment Period

3.5 years

First QC Date

December 8, 2014

Last Update Submit

January 15, 2019

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderCognitive Processing TherapyActive Duty Military

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)

    PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.

    Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

  • Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)

    is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5

    Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

Secondary Outcomes (1)

  • Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9

    Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

Study Arms (1)

CPT-C

EXPERIMENTAL

Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning.

Behavioral: Cognitive Processing Therapy-Cognitive Only

Interventions

Cognitive Processing Therapy-Cognitive OnlyBEHAVIORAL

Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for 4-24 sessions; each session is 60 minutes.

CPT-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male and female combat veterans who deployed in support of combat operations following 9/11
  • Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
  • Speak and read English

You may not qualify if:

  • Current suicide or homicide risk meriting crisis intervention.
  • Active psychosis.
  • Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires).
  • Local availability of fewer than 5 months
  • Late-phase Med Board status, awaiting percentages
  • Undergoing a chapter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Related Publications (2)

  • Hass NC, Wachen JS, Straud CL, Checko E, McGeary DD, McGeary CA, Mintz J, Litz BT, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. Changes in pain and related health outcomes after cognitive processing therapy in an active duty military sample. J Trauma Stress. 2025 Jun;38(3):447-457. doi: 10.1002/jts.23143. Epub 2025 Mar 5.

    PMID: 40045687DERIVED

  • Foa EB, Zandberg LJ, McLean CP, Rosenfield D, Fitzgerald H, Tuerk PW, Wangelin BC, Young-McCaughan S, Peterson AL. The efficacy of 90-minute versus 60-minute sessions of prolonged exposure for posttraumatic stress disorder: Design of a randomized controlled trial in active duty military personnel. Psychol Trauma. 2019 Mar;11(3):307-313. doi: 10.1037/tra0000351. Epub 2018 Feb 12.

    PMID: 29431455DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Patricia A Resick, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Variable length Cognitive Processing Therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 16, 2019

Record last verified: 2018-12

Locations

US(1)