Trial Outcomes & Findings for Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence (NCT NCT02576899)
NCT ID: NCT02576899
Last Updated: 2020-04-10
Results Overview
Smoking outcomes will include a self-report of the number of cigarettes smoked at end of treatment, 1-month follow-up, and the 3-month follow-up, verified by carbon monoxide (CO) breath tests (\< 8 ppm).
COMPLETED
PHASE1
36 participants
Change in smoking abstinence from Baseline to End of Treatment (12 week outcome)
2020-04-10
Participant Flow
Participant milestones
| Measure |
Stage 1b Study of ACT-PT vs. FFS
This study involves a randomized clinical trial study of 50 Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: 10 individual sessions of ACT-PT (n= 25) versus 10 individual sessions of the American Lung Association's Freedom From Smoking Program \[FFS\] (n=25). This study has two primary aims: 1) Evaluate the relative feasibility and acceptability of the two interventions (including ease of recruitment, randomization proportion, staff and Veteran acceptance of the treatment, retention rates, treatment adherence, fidelity, ease of the assessment process), and 2) Evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of tobacco use, PTSD symptoms, health-related quality of life, and functional impairment.
Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
|
Freedom From Smoking
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Baseline characteristics by cohort
| Measure |
ACT-PT
n=16 Participants
Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
|
Freedom From Smoking
n=20 Participants
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.7 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
52.6 Years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
50.9 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Number of Cigarettes
|
21.1 Number of cigarettes smoked
STANDARD_DEVIATION 10.0 • n=5 Participants
|
24.3 Number of cigarettes smoked
STANDARD_DEVIATION 7.5 • n=7 Participants
|
22.5 Number of cigarettes smoked
STANDARD_DEVIATION 9.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change in smoking abstinence from Baseline to End of Treatment (12 week outcome)Smoking outcomes will include a self-report of the number of cigarettes smoked at end of treatment, 1-month follow-up, and the 3-month follow-up, verified by carbon monoxide (CO) breath tests (\< 8 ppm).
Outcome measures
| Measure |
ACT-PT
n=16 Participants
Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
|
Freedom From Smoking
n=20 Participants
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
|
|---|---|---|
|
7-day Point Prevalence of Smoking Abstinence
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Change in PTSD symptoms from Baseline to End of Treatment (12 week outcome)The PCL-5 is a brief, self-report symptom checklist that assesses the 20 symptoms of PTSD outlined in the Diagnostic and Statistical Manual-5 (DSM-5) and was designed to assess symptom changes during and after treatment in addition to screening. The PCL has shown satisfactory temporal stability, internal consistency, test-retest reliability, and convergent validity. The minimum value of the PCL-5 is 0, and the maximum value is 80. Higher scores indicate more severe PTSD symptoms.
Outcome measures
| Measure |
ACT-PT
n=16 Participants
Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
|
Freedom From Smoking
n=20 Participants
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
|
|---|---|---|
|
PTSD Symptoms as Measured by the PTSD Checklist (PCL-5)
|
38.8 units on a scale
Standard Deviation 16.9
|
44.6 units on a scale
Standard Deviation 19.2
|
PRIMARY outcome
Timeframe: Change in Functional Impairment from Baseline to End of Treatment (12 week outcome)The Short Form 36 Health Survey (SF-36) is a 36-item self-report measure of current physical, mental health, and social functioning. We are reporting the mental health functioning outcome. A total score was computed by summing and transforming the five-item scores into a score between 0 (lowest mental health) and 100 (highest mental health). Lower scores indicate more severe functioning related to mental health problems.
Outcome measures
| Measure |
ACT-PT
n=16 Participants
Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
|
Freedom From Smoking
n=20 Participants
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
|
|---|---|---|
|
Functional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)
|
51.3 units on a scale
Standard Deviation 17.8
|
44.3 units on a scale
Standard Deviation 21.0
|
PRIMARY outcome
Timeframe: Change in Quality of Life from Baseline to from Baseline to End of Treatment (12 week outcome)The Quality of Life Enjoyment and Satisfaction Questionnaire is a commonly used self-report measure to assess quality of life in several domains: general activities, physical health, subjective feelings, leisure time activities, social relationships, work, and household duties. Higher scores indicate better enjoyment and satisfaction with life. The scoring of the Quality of Life Enjoyment and Satisfaction Questionnaire involves summing the first 14 items to yield a total score. The total score ranges from 14 to 70 and is expressed as a percentage based on the maximum total score of the items completed (0-100).
Outcome measures
| Measure |
ACT-PT
n=15 Participants
Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
|
Freedom From Smoking
n=19 Participants
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
|
|---|---|---|
|
Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire
|
44.3 units on a scale
Standard Deviation 11.5
|
37.5 units on a scale
Standard Deviation 6.3
|
Adverse Events
ACT-PT
Freedom From Smoking
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place