Smoking Termination / Anxiety Reduction Treatment (ST/ART)
Condition: Smoking; Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this research study is to enhance smoking cessation outcome among smokers
      with anxiety disorders. The investigators are comparing two group treatment approaches: (1)
      An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An
      integrated smoking cessation and anxiety treatment program (START). Both treatments also
      utilize nicotine replacement therapy.
    

Detailed description: 
      The chief objective of the proposed study is to develop an integrated standard smoking
      cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety
      disorders. The intervention is designed to promote smoking cessation and reduce (a) anxiety
      symptoms, (b) depression, and (c) the cognitive factor of AS, thereby reducing three notable
      emotional risk factors of smoking cessation relapse, while at the same time targeting (d)
      nicotine withdrawal symptoms. The intervention development approach will follow a staged
      model consistent with NIH guidelines for developing and standardizing behavioral therapies.
      During the first year, startup activities will include piloting the integrated intervention
      on a subset of individuals, soliciting internal and external expert consultant and
      participant feedback, and development of the final treatment protocol. The goal during this
      phase of the project will be to establish feasibility of treatment delivery, participant
      acceptability, and potential for an effect. During the following two years, a pilot two-arm
      efficacy study will be undertaken. The two arms of the randomized trial (RCT) will be: (a)
      the integrated smoking cessation treatment, consisting of a standard smoking cessation
      intervention (i.e., CBT-Smoking + Nicotine Replacement Therapy [NRT]) plus a transdiagnostic
      CBT for anxiety (Smoking Termination and Anxiety Reduction Treatment; START) or (b) standard
      smoking cessation intervention (i.e., CBT-Smoking + NRT) plus contact control (ST+CTRL). The
      primary outcomes will be short- and long-term point prevalence abstinence (PPA) and time to
      first smoking lapse and relapse. The following specific aims are proposed: 1. To compare, in
      a pilot RCT, the effects of START vs. ST+CTRL on smoking cessation outcomes: Short- and
      longterm PPA. The investigators expect that PPA will be higher, both in the short- and
      longterm, for those in the START condition compared to those in ST+CTRL. Similarly, The
      investigators expect the rate of decline in abstinence over time to be slower in START than
      in ST+CTRL Time to first smoking lapse and time to smoking relapse. The investigators expect
      mean time to first lapse and to relapse to be greater for those in the START compared to
      those in the ST+CTRL condition. 2. To compare, in a pilot RCT, the effect of START vs.
      ST+CTRL on the remission of anxiety disorders, anxiety and depressive symptoms, anxiety
      sensitivity, and nicotine withdrawal symptoms. 3. To explore the mechanisms by which START
      improves smoking cessation. The investigators expect that: Treatments over time will directly
      cause changes in abstinence and withdrawal symptoms, AS, anxiety symptoms, depressed mood
      (i.e., the proposed mediators of change in abstinence); The effect of treatment on anxiety
      symptoms and depressed mood will be moderated by treatment condition, such that those
      receiving START will improve more than those receiving ST+CTRL Changes in each mediator over
      time will lead to improvements in abstinence over time, and decreases in AS over time will
      lead to improvements in anxiety symptoms and depressed mood over time.
    

Intervention name(s): Nicotine Patch; Smoking Termination and Anxiety Reduction Treatment; Education-Supportive Psychotherapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Integrated smoking cessation and anxiety reduction treatment
Other intervention name(s): Patch; NRT
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; stress; smoking; cessation