Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Condition: Tobacco; Posttraumatic Stress Disorder
MeSH terms: Tobacco Use Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Acceptance and Commitment Therapy for PTSD and Tobacco Use; Freedom From Smoking
Intervention description: 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.; The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking cessation; posttraumatic stress disorder; tobacco; treatment; smoking; mindfulness; acceptance; functioning

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.
    

Eligibility criteria:

        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