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Completed

NCT Number: NCT01544088

Group Treatment for PTSD: A Randomized Clinical Trial With Veterans

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Group Cognitive Behavioral Treatment (GCBT)

Behavioral

GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.

Present Centered Group Treatment

Behavioral

The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.

Primary outcomes

  1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: 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 outcomes

  1. Beck Depression Inventory, II (BDI-II)

    Time frame: 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.

  2. Short-Form Health Survey (SF-36)

    Time frame: 12 months

    The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.

  3. Beck Anxiety Inventory (BAI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Group CBT for Chronic PTSD: RCT With Veterans

Acronym: GCBT

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2012
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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