Trial Outcomes & Findings for Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD (NCT NCT02012452)
NCT ID: NCT02012452
Last Updated: 2016-10-27
Results Overview
posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
end of 6 week PTSD treatment
Results posted on
2016-10-27
Participant Flow
19 participants came in for an in-person screening visit. Of those, 9 met inclusion criteria.
Participant milestones
| Measure |
Tobacco Treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Tobacco Treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD
Baseline characteristics by cohort
| Measure |
Tobacco Treatment
n=7 Participants
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
n=2 Participants
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.35 years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
57.05 years
STANDARD_DEVIATION 9.66 • n=7 Participants
|
57.12 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Clinical Administered PTSD scale
|
40.86 units on a scale
STANDARD_DEVIATION 14.51 • n=5 Participants
|
50.0 units on a scale
STANDARD_DEVIATION 8.49 • n=7 Participants
|
42.89 units on a scale
STANDARD_DEVIATION 13.53 • n=5 Participants
|
PRIMARY outcome
Timeframe: end of 6 week PTSD treatmentposttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
Outcome measures
| Measure |
Tobacco Treatment
n=2 Participants
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
n=1 Participants
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
|---|---|---|
|
Clinician Administered PTSD Scale
|
18.67 units on a scale
Standard Deviation 8.33
|
12 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: end of treatmentPopulation: If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.
biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
Outcome measures
| Measure |
Tobacco Treatment
n=7 Participants
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
n=2 Participants
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
|---|---|---|
|
Percent Abstinent From Tobacco Use
|
14.3 percent abstinent
|
0 percent abstinent
|
Adverse Events
Tobacco Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Health Education Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tobacco Treatment
n=7 participants at risk
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
n=2 participants at risk
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
|---|---|---|
|
Gastrointestinal disorders
hospitalization
|
0.00%
0/7 • 25 months
|
50.0%
1/2 • Number of events 1 • 25 months
|
Other adverse events
| Measure |
Tobacco Treatment
n=7 participants at risk
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
Health Education Treatment
n=2 participants at risk
Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic
|
|---|---|---|
|
Psychiatric disorders
psychosis
|
14.3%
1/7 • Number of events 1 • 25 months
|
0.00%
0/2 • 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place