Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
Condition: Mental Health; Stress Disorders, Post-Traumatic; Substance-Related Disorders; Tobacco Use Disorder
MeSH terms: Substance-Related Disorders; Tobacco Use Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary study objective is to conduct a prospective, randomized controlled clinical trial
      that compares the effectiveness of two approaches for delivering smoking cessation treatment
      for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation
      treatment is integrated into mental health care for PTSD and delivered by mental health
      providers (experimental condition) will be compared to specialized smoking cessation clinic
      referral (VA's usual standard of care).

      Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC
      versus USC, (b) identify treatment process variables that explain (mediate) observed
      differences in smoking abstinence rates for the two study conditions, and (c) determine
      whether cessation from smoking is associated with worsening of symptoms of PTSD and/or
      depression.
    

Detailed description: 
      Intervention: The research will test the effectiveness of integrating evidence-based,
      efficacious treatments for tobacco use disorder into mental health care for patients with
      chronic PTSD. Two different methods for delivering smoking cessation treatment will be
      compared in a randomized, controlled clinical effectiveness trial conducted at four
      Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care
      for PTSD who want to quit smoking will be randomly assigned to either (1)
      guideline-concordant smoking cessation treatment integrated within ongoing mental health care
      for PTSD, and delivered by mental health providers (Integrated Care (IC), experimental
      condition), or (2) specialized smoking cessation treatment, delivered separately from PTSD
      treatment by a smoking cessation clinic (Usual Standard of Care (USC), comparison condition).

      Primary Hypothesis: IC will be more effective than USC on measures of smoking-related
      clinical outcomes.

      Secondary Hypothesis: The following treatment process variables will predict smoking
      abstinence at 12-months post randomization: (a) number of smoking cessation treatment
      sessions received, (b) type and duration of protocol medications prescribed by providers
      (bupropion, transdermal nicotine patch, and nicotine gum), (c) degree of subjects' compliance
      with prescribed protocol medication, and (d) number of quit attempts marked by abstinence of
      7 days or more.

      Treatment process variables that predict smoking abstinence will be present to a
      significantly greater degree in IC than USC.

      Primary Outcomes: The primary outcome measure will be the point-prevalence of smoking
      abstinence by self-report for the 7 days prior to assessments, obtained at months 3, 6, 9,
      and 12 following randomization to study conditions. Verification of smoking abstinence will
      be obtained by CO readings (abstinence < 10 ppm) obtained at each assessment interval.
      Salivary cotinine levels (abstinence < 20 ng/ml) will be measured to verify abstinence at
      months 9 and 12 only, as subjects may still be using nicotine replacement medicines at
      earlier assessment intervals, confounding cotinine assays.

      Study Abstract: Individuals with posttraumatic stress disorder (PTSD) are far more likely to
      smoke than those without mental illness and they smoke more heavily. Tobacco use likely
      contributes to the heightened overall mortality and specific risks for smoking related
      diseases among veterans with PTSD and commonly co-occurring mental disorders.

      Symptoms of PTSD and associated mental disorders are linked to the maintenance of tobacco
      dependence, premature dropout from smoking cessation treatment, and relapse to smoking
      following quit attempts. Many efficacious tobacco use treatments exist, but a number of
      barriers limit the effectiveness of current methods for delivering these treatments in VA
      health care settings, particularly for the mentally ill. Novel approaches to smoking
      cessation for individuals with PTSD are needed to circumvent these barriers by integrating
      evidence-based tobacco use treatment into ongoing mental health care. The research proposed
      here will test the effectiveness of integrating evidence-based treatment for nicotine
      dependence into mental health care for patients with chronic posttraumatic stress disorder
      (PTSD). Two different methods for delivering smoking cessation treatment will be compared in
      a prospective, randomized controlled clinical effectiveness trial conducted at four
      Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care
      for PTSD (n=440) will be randomly assigned to either: (1) practice guideline-concordant
      smoking cessation treatment that is integrated within ongoing mental health care for PTSD and
      delivered by mental health providers (Integrated Care [IC]) or 2) smoking cessation treatment
      delivered separately from PTSD treatment by smoking cessation specialists (Usual Standard of
      Care [USC]). Specific aims of the proposed investigation are (1) to demonstrate that IC is
      more effective than USC in reducing smoking in psychiatric patients with PTSD and (2) to
      demonstrate that a number of treatment process variables, including the amount or dose of
      intervention and patient-specific factors, predict abstinence from tobacco use in smokers
      with PTSD. Intent-to-treat analyses and analyses for treatment completers will be conducted,
      using a Generalized Estimating Equations approach. If the study hypothesis is confirmed,
      system-wide implementation of the experimental intervention (IC) for veterans with PTSD would
      double the number of patients who stop smoking compared to the usual standard of care for
      tobacco use disorder. Study findings may have implications for integrating smoking cessation
      treatment into mental health care for patients with disorders other than PTSD.
    

Intervention name(s): Integrated Care for Smoking Cessation in PTSD patients; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Smoking cessation therapy is integrated with PTSD therapy.; Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.
Other intervention name(s): Integrated Care (IC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: addictive disorders; clinical trial; cost effectiveness; mental health; military or environmental exposure; multi-site trial; nicotine; nicotine replacement; post traumatic stress; post traumatic stress disorder; psychiatric; psychological; PTSD; smoking cessation; smoking cessation medications; substance abuse