NCT01286415

Brief Summary

The purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

4.8 years

First QC Date

January 26, 2011

Last Update Submit

March 22, 2017

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderCognitive Processing TherapycombatmilitaryCPTgroup therapy

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic 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)

  • 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

Group Present Centered Therapy

ACTIVE COMPARATOR
Behavioral: Group Present Centered Therapy

Interventions

Group Cognitive Processing Therapy-Cognitive OnlyBEHAVIORAL

Cognitive Processing Therapy (CPT) 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. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.

Group Cognitive Processing Therapy-Cognitive Only
Group Present Centered TherapyBEHAVIORAL

Present Centered Therapy (PCT) is a supportive group intervention typically used within the Department of Veterans Affairs (VA) healthcare systems to address problems of veterans with PTSD (Rosen, et al., 2004). PCT focuses on problem-solving current difficulties that may be related to past traumatic events, but does not address specific memories or cognitions about the trauma. Sessions will be conducted twice weekly for 6 weeks; sessions are 90 minutes.

Group Present Centered Therapy

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)

  • Pruiksma KE, Taylor DJ, Wachen JS, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Borah EV, Dondanville KA, Litz BT, Hembree EA, Resick PA. Residual sleep disturbances following PTSD treatment in active duty military personnel. Psychol Trauma. 2016 Nov;8(6):697-701. doi: 10.1037/tra0000150. Epub 2016 May 30.

    PMID: 27243567BACKGROUND

  • Dondanville KA, Blankenship AE, Molino A, Resick PA, Wachen JS, Mintz J, Yarvis JS, Litz BT, Borah EV, Roache JD, Young-McCaughan S, Hembree EA, Peterson AL; STRONG STAR Consortium. Qualitative examination of cognitive change during PTSD treatment for active duty service members. Behav Res Ther. 2016 Apr;79:1-6. doi: 10.1016/j.brat.2016.01.003. Epub 2016 Feb 4.

    PMID: 26874683BACKGROUND

  • Bryan CJ, Clemans TA, Hernandez AM, Mintz J, Peterson AL, Yarvis JS, Resick PA; STRONG STAR Consortium. EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Depress Anxiety. 2016 Jun;33(6):549-57. doi: 10.1002/da.22456. Epub 2015 Dec 4.

    PMID: 26636426BACKGROUND

  • Resick PA, Wachen JS, Mintz J, Young-McCaughan S, Roache JD, Borah AM, Borah EV, Dondanville KA, Hembree EA, Litz BT, Peterson AL. A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. J Consult Clin Psychol. 2015 Dec;83(6):1058-1068. doi: 10.1037/ccp0000016. Epub 2015 May 4.

    PMID: 25939018RESULT

  • 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

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
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 31, 2011

Study Start

September 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)