GCBT: Group Treatment for PTSD: A Randomized Clinical Trial With Veterans

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01544088
• Collaborator: (none)
• Enrollment: 198
• Locations: 2
• Arms: 2
• Actual Duration (Months): 71
• Patients Per Site: 99
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Group Cognitive Behavioral Treatment (GCBT); Behavioral: Present Centered Group Treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Group CBT for Chronic PTSD: RCT With Veterans
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 23, 2017
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: GCBT Group Cognitive Behavioral treatment (GCBT)	Behavioral: Group Cognitive Behavioral Treatment (GCBT); GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
Active Comparator: Arm 2: Group Treatment Present Centered Group Treatment	Behavioral: Present Centered Group Treatment; The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130
2	Providence VA Medical Center, Providence, RI	Providence	Rhode Island	United States	02908

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Denise M Sloan, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 28, 2016

More Information

Publications

• Sloan DM, Unger W, Gayle Beck J. Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial. Contemp Clin Trials. 2016 Mar;47:123-30. doi: 10.1016/j.cct.2015.12.016. Epub 2015 Dec 21.
• Sloan DM, Unger W, Lee DJ, Beck JG. A Randomized Controlled Trial of Group Cognitive Behavioral Treatment for Veterans Diagnosed With Chronic Posttraumatic Stress Disorder. J Trauma Stress. 2018 Dec;31(6):886-898. doi: 10.1002/jts.22338. Epub 2018 Nov 29.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01544088
• Other Study ID Numbers: MHBA-015-11F; 1I01CX000467-01A1
• First Posted: Mar 5, 2012
• Last Update Posted: Mar 23, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: randomized controlled trial; PTSD; cognitive behavioral treatment; group treatment
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)	Present Centered Group Treatment
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.	Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Period Title: Overall Study
STARTED	98	100
COMPLETED	61	79
NOT COMPLETED	37	21

Baseline Characteristics

Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)	Present Centered Group Treatment	Total
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.	Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.	Total of all reporting groups
Overall Participants	98	100	198
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	75 76.5%	67 67%	142 71.7%
>=65 years	23 23.5%	33 33%	56 28.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.40 (11.44)	57.22 (12.51)	55.82 (12.05)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	98 100%	100 100%	198 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 2%	1 1%	3 1.5%
Asian	1 1%	0 0%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	14 14.3%	19 19%	33 16.7%
White	75 76.5%	72 72%	147 74.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	6 6.1%	8 8%	14 7.1%
Region of Enrollment (Count of Participants)
United States	98 100%	100 100%	198 100%
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	39.84 (9.84)	39.37 (9.52)	39.60 (9.66)
Beck Depression Inventory, II (BDI-II) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23.85 (11.95)	23.94 (11.65)	23.89 (11.77)
Beck Anxiety Inventory (BAI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.22 (11.31)	20.97 (12.15)	19.61 (11.80)
Short-Form Health Survey (SF-36) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	39.43 (26.60)	42.88 (26.37)	41.18 (26.47)

Outcome Measures

1. Primary Outcome

Title	Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Primary treatment outcomes were examined using hierarchical linear modeling.

Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)	Present Centered Group Treatment
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.	Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Measure Participants	98	100
Mean (Standard Deviation) [units on a scale]	28.76 (13.46)	31.87 (14.70)

2. Secondary Outcome

Title	Beck Depression Inventory, II (BDI-II)
Description	The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)	Present Centered Group Treatment
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.	Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Measure Participants	98	100
Mean (Standard Deviation) [units on a scale]	18.95 (12.67)	22.29 (13.20)

3. Secondary Outcome

Title	Short-Form Health Survey (SF-36)
Description	The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)	Present Centered Group Treatment
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.	Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Measure Participants	98	100
Mean (Standard Deviation) [units on a scale]	55.00 (28.71)	59.05 (27.21)

4. Secondary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)	Present Centered Group Treatment
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.	Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Measure Participants	98	100
Mean (Standard Deviation) [units on a scale]	15.23 (12.34)	18.67 (13.77)

Adverse Events

Time Frame	1 year, 4 months
Adverse Event Reporting Description	Adverse events were collected based on participant self-report as well as documentation in the VA electronic medical record. As standard practice, all adverse reports were documented, whether or not they were probably or likely related to study participation.
Arm/Group Title	Group Cognitive Behavioral Treatment (GCBT)		Present Centered Group Treatment
Arm/Group Description	Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.		Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
All Cause Mortality
	Group Cognitive Behavioral Treatment (GCBT)		Present Centered Group Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/100 (0%)
Serious Adverse Events
	Group Cognitive Behavioral Treatment (GCBT)		Present Centered Group Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/98 (15.3%)		22/100 (22%)
Gastrointestinal disorders
GI illness	3/98 (3.1%)	3	1/100 (1%)	1
General disorders
General disorders	2/98 (2%)	2	4/100 (4%)	4
Infections and infestations
Infection disease	3/98 (3.1%)	3	2/100 (2%)	2
Psychiatric disorders
psychiatric hospitalization	4/98 (4.1%)	4	9/100 (9%)	9
Renal and urinary disorders
Uninary disorder	1/98 (1%)	1	2/100 (2%)	2
Surgical and medical procedures
hospitalization due to medical illness	2/98 (2%)	2	4/100 (4%)	4
Other (Not Including Serious) Adverse Events
	Group Cognitive Behavioral Treatment (GCBT)		Present Centered Group Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/100 (0%)

Limitations/Caveats

No women veterans were included in the study, therefore findings are not generalizable to women veterans.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.