Group Treatment for PTSD: A Randomized Clinical Trial With Veterans

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Present Centered Group Treatment; Behavioral: Group Cognitive Behavioral Treatment (GCBT)

• Registration Number: NCT01544088
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.

Detailed Description

The mental health needs of Veterans within the VA Healthcare system are notable. With the substantial increase over the past 10 years in Veterans seeking Posttraumatic Stress Disorder (PTSD) treatment services, the VA system is straining to accommodate these needs, relying heavily on group-based treatments. The proposed research will take the next step in the literature on group psychotherapy for PTSD by examining a group cognitive behavioral treatment (GCBT) program with promising pilot data. This application supports a randomized controlled trial, which will compare GCBT with Supportive Group Psychotherapy (SGP). The trial will involve 196 male Veterans with combat-related PTSD who will be randomly assigned to GCBT (n= 98) or SGP (n =98) to determine efficacy within a naturalistic care environment. Outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Two aims are included, one focusing on outcome with respect to PTSD symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. Data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. The information provided by the proposed project could assist in developing more effective care models for individuals with chronic PTSD from numerous traumatic experiences. Additionally, this project represents an effort to move the literature on group-based treatments for PTSD ahead, through inclusion of advanced methodological and analytic approaches.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-05
• Study Start: 2012-07-01
• Primary Completion: 2017-08-23
• Study Completion: 2018-06-01
• Results First Submitted: 2018-06-13
• Results First Submitted QC: 2019-04-26
• Results First Posted: 2019-04-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 198

Inclusion Criteria

• primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more)
• male, Veteran
• be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia

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Exclusion Criteria

• a current diagnosis of substance dependence or unstable bipolar disorder
• currently involved in psychosocial treatment for PTSD

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Group Treatment	Present Centered Group Treatment	Present Centered Group Treatment
Arm 1: GCBT	Group Cognitive Behavioral Treatment (GCBT)	Group Cognitive Behavioral treatment (GCBT)

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	12 months	The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity.

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (BAI)	12 months	The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Beck Depression Inventory, II (BDI-II)	12 months	The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Short-Form Health Survey (SF-36)	12 months	The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.

Trial Locations

Locations (2)

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States