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Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Cognitive Processing Therapy-Cognitive Only
Individual Cognitive Processing Therapy-Cognitive Only
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Cognitive Processing Therapy, combat, military, CPT, group therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Fort Hood Army Base

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group Cognitive Processing Therapy-Cognitive Only

Individual Cognitive Processing Therapy-Cognitive Only

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II
The BDI-II is one of the most widely used instruments for measuring the severity of depressive symptoms. It consists of 21 items that assess both affective and somatic symptoms related to depression and depressive disorders. Each item is composed of four statements that reflect symptom severity. The statements are scaled from 0 (no disturbance) to 3 (maximal disturbance). Scores on all items are summed to obtain a total severity score.

Full Information

First Posted
June 19, 2014
Last Updated
March 22, 2017
Sponsor
Duke University
Collaborators
VA Boston Healthcare System, The University of Texas Health Science Center at San Antonio, STRONG STAR Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT02173561
Brief Title
Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD
Official Title
Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
Collaborators
VA Boston Healthcare System, The University of Texas Health Science Center at San Antonio, STRONG STAR Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Estimates indicate that between 100,000 and 300,000 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are at significant risk for chronic post-traumatic stress disorder (PTSD), which can become a chronic disorder that impacts all areas of a person's life. PTSD treatment programs are being developed throughout the Department of Defense (DoD) and the Veterans Affairs (VA), but because of the large number of Service Members returning from deployment with PTSD, it is often necessary to provide psychotherapy in groups. Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, was originally developed as a group-based intervention. However, group-based CPT treatment has never been systematically compared to individual CPT treatment. The public policy implications of the results of this trial are significant. If both treatment formats are equivalent or if group treatment is better, then group treatment would be a more efficient and cost-effective therapy modality in most cases. On the other hand, if individual therapy is found to be superior, the investment of greater resources into individual therapy will be justified in order to provide the most effective treatment for PTSD to military personnel. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Three hundred (300) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study. Participants will be randomized between group and individual CPT-C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Cognitive Processing Therapy, combat, military, CPT, group therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Cognitive Processing Therapy-Cognitive Only
Arm Type
Experimental
Arm Title
Individual Cognitive Processing Therapy-Cognitive Only
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Processing Therapy-Cognitive Only
Other Intervention Name(s)
Group CPT-C
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Cognitive Processing Therapy-Cognitive Only
Other Intervention Name(s)
Individual CPT-C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)
Description
PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor.
Time Frame
Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II
Description
The BDI-II is one of the most widely used instruments for measuring the severity of depressive symptoms. It consists of 21 items that assess both affective and somatic symptoms related to depression and depressive disorders. Each item is composed of four statements that reflect symptom severity. The statements are scaled from 0 (no disturbance) to 3 (maximal disturbance). Scores on all items are summed to obtain a total severity score.
Time Frame
Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A Resick, PhD, ABPP
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fort Hood Army Base
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76544
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27893032
Citation
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. Erratum In: JAMA Psychiatry. 2017 Jun 1;74(6):655.
Results Reference
result
PubMed Identifier
35901423
Citation
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. 2022 Jul 28. doi: 10.1037/tra0001292. Online ahead of print.
Results Reference
derived
PubMed Identifier
33078467
Citation
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.
Results Reference
derived
Links:
URL
http://www.strongstar.org
Description
Related Info

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Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD

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