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Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02576899
Acronym
ACT-PT
Enrollment
36
Registered
2015-10-15
Start date
2015-09-01
Completion date
2019-12-31
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder, Tobacco

Keywords

smoking cessation, posttraumatic stress disorder, tobacco, treatment, smoking, mindfulness, acceptance, functioning

Brief summary

Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting for many Veterans. In addition, no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD and tobacco use negatively affect functioning across physical, mental health, and social domains. The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values. This project involves a small randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: ACT-PT versus the American Lung Association's Freedom From Smoking Program \[FFS\]. 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.

Detailed description

Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Only 23% of individuals with PTSD quit smoking compared to 50% of the general population. As a result, Veterans with PTSD are at high risk of developing severe health problems and poor physical functioning. Fifty percent of these long-term smokers will die of a smoking-related cause and on average, will lose 25 years of their life compared to non-smokers. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting for many Veterans. In addition, no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD and tobacco use negatively affect functioning across physical, mental health, and social domains. The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values. This emphasis on substantially improving health-related quality of life and functioning across several areas makes ACT-PT particularly innovative and different from existing treatments. However, research is needed on the relative feasibility, acceptability, and efficacy of ACT-PT compared to standard smoking cessation treatments. This project involves a randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: ACT-PT versus the American Lung Association's Freedom From Smoking Program \[FFS\] with all participants. 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.

Interventions

BEHAVIORALAcceptance 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. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values.

BEHAVIORALFreedom 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veterans enrolled at the Edith Nourse Rogers Memorial Veterans Hospital * Current Diagnostic and Statistical Manual (DSM-5) Diagnosis of PTSD * Minimum score of 38 (clinical cutoff for PTSD) on the PTSD Checklist for DSM-5 * A regular smoker for at least 3 years * Currently smoking at least 10 cigarettes per day * Able to communicate meaningfully with the investigator * Competent to provide written informed consent * Ages 18 and older

Exclusion criteria

* Current unstable DSM-5 bipolar disorder \[i.e., instability characterized by two or more manic or depressive episodes in the past 12 months, and a current Young Mania Rating Scale total score of 13 or a current Beck Depression Inventory (BDI) score of 19\] * Any lifetime DSM-5 psychotic disorder * Current or recent (within 1 month of study entry) moderate or severe DSM-5 alcohol or drug use disorder * Use of other tobacco products * A cognitive impairment that would interfere with participation * A suicide attempt or severe suicidal ideation within the past 3 months * Presence of any clinical features requiring inpatient or partial hospital treatment * Use of any other tobacco cessation counseling

Design outcomes

Primary

MeasureTime frameDescription
7-day Point Prevalence of Smoking AbstinenceChange 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).
PTSD Symptoms as Measured by the PTSD Checklist (PCL-5)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.
Functional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)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.
Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction QuestionnaireChange 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
ACT-PT
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.
16
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.
20
Total36

Baseline characteristics

CharacteristicACT-PTFreedom From SmokingTotal
Age, Continuous48.7 Years
STANDARD_DEVIATION 12.3
52.6 Years
STANDARD_DEVIATION 12.9
50.9 Years
STANDARD_DEVIATION 12.6
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants19 Participants35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Number of Cigarettes21.1 Number of cigarettes smoked
STANDARD_DEVIATION 10
24.3 Number of cigarettes smoked
STANDARD_DEVIATION 7.5
22.5 Number of cigarettes smoked
STANDARD_DEVIATION 9
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
15 Participants19 Participants34 Participants
Region of Enrollment
United States
16 Participants20 Participants36 Participants
Sex: Female, Male
Female
3 Participants4 Participants7 Participants
Sex: Female, Male
Male
13 Participants16 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 20
other
Total, other adverse events
0 / 160 / 20
serious
Total, serious adverse events
0 / 160 / 20

Outcome results

Primary

7-day Point Prevalence of Smoking Abstinence

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).

Time frame: Change in smoking abstinence from Baseline to End of Treatment (12 week outcome)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACT-PT7-day Point Prevalence of Smoking Abstinence4 Participants
Freedom From Smoking7-day Point Prevalence of Smoking Abstinence0 Participants
Primary

Functional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)

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.

Time frame: Change in Functional Impairment from Baseline to End of Treatment (12 week outcome)

ArmMeasureValue (MEAN)Dispersion
ACT-PTFunctional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)51.3 units on a scaleStandard Deviation 17.8
Freedom From SmokingFunctional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)44.3 units on a scaleStandard Deviation 21
Primary

PTSD Symptoms as Measured by the PTSD Checklist (PCL-5)

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.

Time frame: Change in PTSD symptoms from Baseline to End of Treatment (12 week outcome)

ArmMeasureValue (MEAN)Dispersion
ACT-PTPTSD Symptoms as Measured by the PTSD Checklist (PCL-5)38.8 units on a scaleStandard Deviation 16.9
Freedom From SmokingPTSD Symptoms as Measured by the PTSD Checklist (PCL-5)44.6 units on a scaleStandard Deviation 19.2
Primary

Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire

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).

Time frame: Change in Quality of Life from Baseline to from Baseline to End of Treatment (12 week outcome)

ArmMeasureValue (MEAN)Dispersion
ACT-PTQuality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire44.3 units on a scaleStandard Deviation 11.5
Freedom From SmokingQuality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire37.5 units on a scaleStandard Deviation 6.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026