Trial Outcomes & Findings for Group Treatment for PTSD: A Randomized Clinical Trial With Veterans (NCT NCT01544088)

Last Updated: 2020-03-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

198 participants

Primary outcome timeframe

12 months

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Group Cognitive Behavioral Treatment (GCBT) 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 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.
Overall Study STARTED	98	100
Overall Study COMPLETED	61	79
Overall Study NOT COMPLETED	37	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Group Treatment for PTSD: A Randomized Clinical Trial With Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Cognitive Behavioral Treatment (GCBT) n=98 Participants 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 n=100 Participants 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 n=198 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	67 Participants n=7 Participants	142 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Age, Continuous	54.40 years STANDARD_DEVIATION 11.44 • n=5 Participants	57.22 years STANDARD_DEVIATION 12.51 • n=7 Participants	55.82 years STANDARD_DEVIATION 12.05 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	100 Participants n=7 Participants	198 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	72 Participants n=7 Participants	147 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	98 Participants n=5 Participants	100 Participants n=7 Participants	198 Participants n=5 Participants
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	39.84 units on a scale STANDARD_DEVIATION 9.84 • n=5 Participants	39.37 units on a scale STANDARD_DEVIATION 9.52 • n=7 Participants	39.60 units on a scale STANDARD_DEVIATION 9.66 • n=5 Participants
Beck Depression Inventory, II (BDI-II)	23.85 units on a scale STANDARD_DEVIATION 11.95 • n=5 Participants	23.94 units on a scale STANDARD_DEVIATION 11.65 • n=7 Participants	23.89 units on a scale STANDARD_DEVIATION 11.77 • n=5 Participants
Beck Anxiety Inventory (BAI)	18.22 units on a scale STANDARD_DEVIATION 11.31 • n=5 Participants	20.97 units on a scale STANDARD_DEVIATION 12.15 • n=7 Participants	19.61 units on a scale STANDARD_DEVIATION 11.80 • n=5 Participants
Short-Form Health Survey (SF-36)	39.43 units on a scale STANDARD_DEVIATION 26.60 • n=5 Participants	42.88 units on a scale STANDARD_DEVIATION 26.37 • n=7 Participants	41.18 units on a scale STANDARD_DEVIATION 26.47 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Primary treatment outcomes were examined using hierarchical linear modeling.

Outcome measures

Outcome measures
Measure	Group Cognitive Behavioral Treatment (GCBT) n=98 Participants 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 n=100 Participants 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.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	28.76 units on a scale Standard Deviation 13.46	31.87 units on a scale Standard Deviation 14.70

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group Cognitive Behavioral Treatment (GCBT) n=98 Participants 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 n=100 Participants 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.
Beck Depression Inventory, II (BDI-II)	18.95 units on a scale Standard Deviation 12.67	22.29 units on a scale Standard Deviation 13.20

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Group Cognitive Behavioral Treatment (GCBT) n=98 Participants 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 n=100 Participants 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.
Short-Form Health Survey (SF-36)	55.00 units on a scale Standard Deviation 28.71	59.05 units on a scale Standard Deviation 27.21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group Cognitive Behavioral Treatment (GCBT) n=98 Participants 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 n=100 Participants 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.
Beck Anxiety Inventory (BAI)	15.23 units on a scale Standard Deviation 12.34	18.67 units on a scale Standard Deviation 13.77

Adverse Events

Group Cognitive Behavioral Treatment (GCBT)

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Present Centered Group Treatment

Serious events: 22 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group Cognitive Behavioral Treatment (GCBT) n=98 participants at risk 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 n=100 participants at risk 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.
Surgical and medical procedures hospitalization due to medical illness	2.0% 2/98 • Number of events 2 • 1 year, 4 months 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.	4.0% 4/100 • Number of events 4 • 1 year, 4 months 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.
Psychiatric disorders psychiatric hospitalization	4.1% 4/98 • Number of events 4 • 1 year, 4 months 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.	9.0% 9/100 • Number of events 9 • 1 year, 4 months 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.
General disorders General disorders	2.0% 2/98 • Number of events 2 • 1 year, 4 months 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.	4.0% 4/100 • Number of events 4 • 1 year, 4 months 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.
Renal and urinary disorders Uninary disorder	1.0% 1/98 • Number of events 1 • 1 year, 4 months 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.	2.0% 2/100 • Number of events 2 • 1 year, 4 months 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.
Infections and infestations Infection disease	3.1% 3/98 • Number of events 3 • 1 year, 4 months 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.	2.0% 2/100 • Number of events 2 • 1 year, 4 months 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.
Gastrointestinal disorders GI illness	3.1% 3/98 • Number of events 3 • 1 year, 4 months 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.	1.0% 1/100 • Number of events 1 • 1 year, 4 months 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.

Other adverse events

Adverse event data not reported

Additional Information

Denise Sloan, Ph.D.

VA Boston Healthcare System

Phone: (857) 364-6333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place