Clinical trial NCT02173561: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Cognitive Processing Therapy
combat
military
CPT
group therapy
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
name: The University of Texas Health Science Center at San Antonio
name: STRONG STAR Consortium
First posted: 2014-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)
timeFrame: Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up
Secondary outcomes:
measure: Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II
timeFrame: Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Fort Hood Army Base
state: Texas
Study officials:
affiliation: Duke University
name: Patricia A Resick, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2023 Nov;15(8):1398-1405. doi: 10.1037/tra0001292. Epub 2022 Jul 28.
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.