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Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence (ACT-PT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02576899
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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. 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.

The proposed SPiRE (I21) will involve 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) with all participants receiving 12 weeks of the nicotine patch. 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.


Condition or disease Intervention/treatment Phase
Tobacco Posttraumatic Stress Disorder Behavioral: Acceptance and Commitment Therapy for PTSD and Tobacco Use Behavioral: Freedom From Smoking Phase 1

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.

The proposed SPiRE (I21) will involve 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) with all participants receiving 12 weeks of the nicotine patch. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : March 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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. 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.

Placebo Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. 7-day point prevalence of smoking abstinence [ Time Frame: Change in smoking abstinence from Baseline to Study Completion at 28 weeks ]
    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).

  2. PTSD symptoms as measured by the PTSD Checklist for DSM 5 [ Time Frame: Change in PTSD symptoms from Baseline to Study Completion at 28 weeks ]
    PTSD symptoms on the PTSD Checklist for DSM 5

  3. Functional Impairment as measured by the The Short Form 36 Health Survey (SF-36) [ Time Frame: Change in Functional Impairment from Baseline to Study Completion at 28 weeks ]
    The Short Form 36 Health Survey (SF-36) is a 36-item self-report measure of current physical, mental health, and social functioning.

  4. Quality of Life as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Change in Quality of Life from Baseline to Study Completion at 28 weeks ]
    The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans enrolled at the Edith Nourse Rogers Memorial Veterans Hospital
  • Current DSM-5 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 13 or a current BDI score 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576899


Locations
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United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Megan Marie Kelly, PhD MS Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02576899     History of Changes
Other Study ID Numbers: D1756-P
121RX-001756-01A1 ( Other Grant/Funding Number: VA RR&D )
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
smoking cessation
posttraumatic stress disorder
tobacco
treatment
smoking
mindfulness
acceptance
functioning

Additional relevant MeSH terms:
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Tobacco Use Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders