Trial Outcomes & Findings for Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs (NCT NCT01357577)

Last Updated: 2020-01-29

Results Overview

PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS). The Clinician Administered PTSD SCALE (CAPS) is the gold standard in PTSD assessment. It is a structured interview that can be used to: Make current (past month) diagnosis of PTSD and Make lifetime diagnosis of PTSD. The minimum value is a 0 and the maximum is 135, the higher the score the worse the outcome, i.e. the more severe PTSD.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up

Results posted on

2020-01-29

Participant Flow

Participants were recruited from three Veteran Affairs Medical Centers (VAMC): Syracuse, NY VAMC; Tampa Bay, FL VAMC; and White River Junction, VT VAMC. Participants were recruited from outpatient and inpatient clinics at the three respective facilities.

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU) The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual (TAU) The "no intervention" group will receive treatment as usual (TAU).
Overall Study STARTED	64	65
Overall Study Post-Treatment Assessment Completed	24	39
Overall Study COMPLETED	27	39
Overall Study NOT COMPLETED	37	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU) The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual (TAU) The "no intervention" group will receive treatment as usual (TAU).
Overall Study Lost to Follow-up	20	16
Overall Study Withdrawal by Subject	16	8
Overall Study look at data in database?	1	2

Baseline Characteristics

Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy + Treatment as Usual n=64 Participants The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual n=65 Participants The "no intervention" group will receive treatment as usual (TAU) without additional individual treatment..	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=93 Participants	65 Participants n=4 Participants	129 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous Age (years)	42.2 years STANDARD_DEVIATION 12.5 • n=93 Participants	45.9 years STANDARD_DEVIATION 11.5 • n=4 Participants	44.2 years STANDARD_DEVIATION 12.1 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	61 Participants n=93 Participants	61 Participants n=4 Participants	122 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=93 Participants	58 Participants n=4 Participants	115 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	15 Participants n=93 Participants	19 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) White	46 Participants n=93 Participants	42 Participants n=4 Participants	88 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	64 Participants n=93 Participants	65 Participants n=4 Participants	129 Participants n=27 Participants

PRIMARY outcome

Timeframe: Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up

Population: Our intention-to-treat analysis has N=80 patients (33 CBT; 47 control): It consists of patients with at least one follow-up (post or 6-mo) assessment (e.g., of the 64 participants randomized to CBT, 24 and 27 had a CAPS assessment at post and 6 months, respectively, with 33 participants having at least one valid follow-up CAPS).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy + Treatment as Usual n=33 Participants The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual n=47 Participants The "no intervention" group will receive treatment as usual (TAU) without additional treatment.
CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. CAPS Total Baseline	77.2 score on scale Standard Deviation 18.4	78.0 score on scale Standard Deviation 16.2
CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. CAPS Total Post-Treatment	67.5 score on scale Standard Deviation 26.3	71.0 score on scale Standard Deviation 26.4
CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. CAPS Total 6 Months	72.2 score on scale Standard Deviation 21.6	62.9 score on scale Standard Deviation 21.9

SECONDARY outcome

Timeframe: Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months

The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy + Treatment as Usual n=31 Participants The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual n=41 Participants The "no intervention" group will receive treatment as usual (TAU) without additional treatment.
Addiction Severity Index (Alcohol Addiction) Alcohol Baseline	.25 score on scale Standard Deviation .22	.25 score on scale Standard Deviation .25
Addiction Severity Index (Alcohol Addiction) Alcohol Post-Treatment	.13 score on scale Standard Deviation .17	.17 score on scale Standard Deviation .22
Addiction Severity Index (Alcohol Addiction) Alcohol 6-Months	.18 score on scale Standard Deviation .18	.20 score on scale Standard Deviation .27

SECONDARY outcome

Timeframe: Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy + Treatment as Usual n=32 Participants The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual n=42 Participants The "no intervention" group will receive treatment as usual (TAU) without additional treatment.
Addiction Severity Index (Drug Use) Drug Use Baseline	.17 score on scale Standard Deviation .18	.10 score on scale Standard Deviation .11
Addiction Severity Index (Drug Use) Drug Use Post-Treatment	.09 score on scale Standard Deviation .18	.08 score on scale Standard Deviation .13
Addiction Severity Index (Drug Use) Drug Use 6-Months	.11 score on scale Standard Deviation .15	.04 score on scale Standard Deviation .08

SECONDARY outcome

Timeframe: Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months

A secondary measure of PTSD will be the PCL. The PCL is a widely used self-report measure that assesses the 17 DSM-IV PTSD symptoms. Responses to these questions are on a scale of 1 to 5 ("not at all" to "extremely"). A total symptom severity score (range from 17-85) can be calculated, with a higher score indicating higher symptom severity.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy + Treatment as Usual n=31 Participants The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual n=45 Participants The "no intervention" group will receive treatment as usual (TAU) without additional treatment.
PTSD Checklist (PCL) PCL Baseline	62.7 score on scale Standard Deviation 9.2	62.1 score on scale Standard Deviation 13.3
PTSD Checklist (PCL) PCL Post-Treatment	54.3 score on scale Standard Deviation 17.7	56.9 score on scale Standard Deviation 15.7
PTSD Checklist (PCL) PCL 6-months	56.7 score on scale Standard Deviation 13.7	54.2 score on scale Standard Deviation 16.9

SECONDARY outcome

Timeframe: Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months

Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is adapted from the PRIME-MD. It can be used as a screen for depression or as a severity measure. The investigators used it as a measure of severity. The PHQ-9 score is on a range of 0 to 27, where a higher score indicates higher severity.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy + Treatment as Usual n=31 Participants The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual n=45 Participants The "no intervention" group will receive treatment as usual (TAU) without additional treatment.
Patient Health Questionnaire-9 (PHQ-9) PHQ-9 Baseline	16.0 score on a scale Standard Deviation 4.7	14.8 score on a scale Standard Deviation 6.8
Patient Health Questionnaire-9 (PHQ-9) PHQ-9 Post-Treatment	15.0 score on a scale Standard Deviation 7.4	12.8 score on a scale Standard Deviation 7.2
Patient Health Questionnaire-9 (PHQ-9) PHQ-9 6-months	15.8 score on a scale Standard Deviation 17.1	12.2 score on a scale Standard Deviation 7.4

Adverse Events

Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU)

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Treatment as Usual (TAU)

Serious events: 13 serious events

Other events: 21 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU) n=64 participants at risk The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual (TAU) n=65 participants at risk The "no intervention" group will receive treatment as usual (TAU).
Psychiatric disorders Mental Health Episode resulting in hospital encounter	14.1% 9/64 • Number of events 9 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	10.8% 7/65 • Number of events 7 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Renal and urinary disorders Hospitalization for kidney failure	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Cardiac disorders Myocardial infarction	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	3.1% 2/65 • Number of events 2 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Musculoskeletal and connective tissue disorders Hospitalization due to hip replacement surgery	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Social circumstances incarceration	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Respiratory, thoracic and mediastinal disorders inpatient stay for untreated COPD	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Renal and urinary disorders Testicular and groin surgery resulting in inpatient hospital stay	1.6% 1/64 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	0.00% 0/65 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Nervous system disorders hospitalization due to syncopal episode	1.6% 1/64 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	0.00% 0/65 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:

Other adverse events

Other adverse events
Measure	Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU) n=64 participants at risk The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.	Treatment as Usual (TAU) n=65 participants at risk The "no intervention" group will receive treatment as usual (TAU).
Psychiatric disorders Mental Health and/or Substance Abuse ER visit	100.0% 10/10 • Number of events 10 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	12.3% 8/65 • Number of events 8 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Social circumstances Jail	1.6% 1/64 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Eye disorders corneal abrasion	1.6% 1/64 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	0.00% 0/65 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
General disorders ER visit due to dental pain and/or possible dental abscess	1.6% 1/64 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
General disorders chronic pain	4.7% 3/64 • Number of events 3 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Musculoskeletal and connective tissue disorders musculature pain and discomfort	6.2% 4/64 • Number of events 4 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Cardiac disorders chest pain	1.6% 1/64 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	0.00% 0/65 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Gastrointestinal disorders abdominal pain	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	3.1% 2/65 • Number of events 2 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Musculoskeletal and connective tissue disorders low back pain	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Renal and urinary disorders kidney stones	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
General disorders headache	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	3.1% 2/65 • Number of events 2 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Blood and lymphatic system disorders hemophilia	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
General disorders testicular pain	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
Injury, poisoning and procedural complications motor vehicle accident which results in paralysis	0.00% 0/64 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:	1.5% 1/65 • Number of events 1 • Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions. Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:

Additional Information

Jessica L. Hamblen, PhD

VA National Center for PTSD

Phone: 8022965132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place