NCT02173561

Brief Summary

The purpose of this study is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

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

Study Start

First participant enrolled

June 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3.6 years

First QC Date

June 19, 2014

Last Update Submit

March 22, 2017

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderCognitive Processing TherapycombatmilitaryCPTgroup therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)

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

    Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up

Secondary Outcomes (1)

  • Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II

    Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up

Study Arms (2)

Group Cognitive Processing Therapy-Cognitive Only

EXPERIMENTAL
Behavioral: Group Cognitive Processing Therapy-Cognitive Only

Individual Cognitive Processing Therapy-Cognitive Only

EXPERIMENTAL
Behavioral: Individual Cognitive Processing Therapy-Cognitive Only

Interventions

Group Cognitive Processing Therapy-Cognitive OnlyBEHAVIORAL

Cognitive Processing Therapy-Cognitive Only version (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT-C is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted in groups of 8-12 participants. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.

Also known as: Group CPT-C
Group Cognitive Processing Therapy-Cognitive Only
Individual 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 12-session 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 six weeks; each session is 60 minutes.

Also known as: Individual CPT-C
Individual Cognitive Processing Therapy-Cognitive Only

Eligibility Criteria

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

You may qualify if:

  • Adult male and female active duty, activated Reservist, or activated National Guard OIF/OEF military personnel or OIF/OEF veterans seeking treatment for PTSD
  • Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSSI)
  • Person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of OIF/OEF. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
  • Be over the age of 18
  • Speak and read English
  • Be stable on any psychotropic medications they may be taking.

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Hood Army Base

Fort Hood, Texas, 76544, United States

Location

Related Publications (5)

  • Resick PA, Wachen JS, Dondanville KA, Pruiksma KE, Yarvis JS, Peterson AL, Mintz J; and the STRONG STAR Consortium; Borah EV, Brundige A, Hembree EA, Litz BT, Roache JD, Young-McCaughan S. Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):28-36. doi: 10.1001/jamapsychiatry.2016.2729.

    PMID: 27893032RESULT

  • Pruiksma KE, Taylor DJ, Wachen JS, Straud CL, Hale WJ, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Borah EV, Dondanville KA, Litz BT, Resick PA. Self-reported sleep problems in active-duty US Army personnel receiving posttraumatic stress disorder treatment in group or individual formats: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2023 Aug 1;19(8):1389-1398. doi: 10.5664/jcsm.10584.

    PMID: 36988304DERIVED

  • Wachen JS, Mintz J, LoSavio ST, Kennedy JE, Hale WJ, Straud CL, Dondanville KA, Moring J, Blankenship AE, Vandiver R, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. The impact of prior head injury on outcomes following group and individual cognitive processing therapy among military personnel. J Trauma Stress. 2022 Dec;35(6):1684-1695. doi: 10.1002/jts.22870. Epub 2022 Aug 29.

    PMID: 36039506DERIVED

  • Miles SR, Hale WJ, Mintz J, Wachen JS, Litz BT, Dondanville KA, Yarvis JS, Hembree EA, Young-McCaughan S, Peterson AL, Resick PA. Hyperarousal symptoms linger after successful PTSD treatment in active duty military. Psychol Trauma. 2023 Nov;15(8):1398-1405. doi: 10.1037/tra0001292. Epub 2022 Jul 28.

    PMID: 35901423DERIVED

  • Straud CL, Dondanville KA, Hale WJ, Wachen JS, Mintz J, Litz BT, Roache JD, Yarvis JS, Young-McCaughan S, Peterson AL, Resick PA; STRONG STAR Consortium. The Impact of Hazardous Drinking Among Active Duty Military With Posttraumatic Stress Disorder: Does Cognitive Processing Therapy Format Matter? J Trauma Stress. 2021 Feb;34(1):210-220. doi: 10.1002/jts.22609. Epub 2020 Oct 19.

    PMID: 33078467DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Patricia A Resick, PhD, ABPP

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 25, 2014

Study Start

June 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)