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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173561
• Other study ID #: W81XWH-08-2-0116-1
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: March 22, 2017
• Start date: June 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Group Cognitive Processing Therapy-Cognitive Only
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.
• Individual Cognitive Processing Therapy-Cognitive Only
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.

Locations

Country	Name	City	State
United States	Fort Hood Army Base	Fort Hood	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	STRONG STAR Consortium, The University of Texas Health Science Center at San Antonio, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Act — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up

External Links

•   Link