Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Condition: Nicotine Dependence; Symptoms of Anxiety; HIV
MeSH terms: Tobacco Use Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      During the 1-year formative phase of a study to develop an integrated treatment for quitting
      smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up
      activities will include piloting the integrated treatment on a small group of individuals (N
      = up to 12), obtaining expert consultant and participant feedback, and development of the
      final treatment manual and procedures. The goal during this phase will be to establish
      feasibility of treatment delivery, participant acceptability, and potential for a treatment
      effect before conducting a pilot randomized trial of the treatment. During the two-year pilot
      RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral
      and pharmacological smoking cessation intervention for HIV+ smokers with interfering
      psychological distress.
    

Detailed description: 
      This study represents an important step in treating nicotine dependence in HIV-positive
      individuals. This study addresses an important public health issue by assessing an
      intervention that may lead to a more effective application for the treatment of at-risk HIV+
      smokers. The 1-year formative phase of the study will develop an integrated treatment for
      quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include
      cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and
      cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be
      conducted with a small group of individuals (N = up to 12). This phase will be used to
      establish feasibility of treatment delivery, and participant acceptability before conducting
      a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking
      cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms
      through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This
      study represents an important step in treating nicotine dependence in HIV-positive
      individuals. This study addresses an important public health issue by assessing an
      intervention that may lead to a more effective application for the treatment of at-risk HIV+
      smokers. The pilot RCT phase of the study (years 2 and 3), will test the developed
      cognitive-behavioral intervention in a pilot randomized-controlled trial format. The outcomes
      for this trial will be to determine the acceptability and feasibility of the intervention and
      the potential for an effect on increasing point prevalence abstinence and deceasing
      psychological distress.
    

Intervention name(s): Integrated cognitive-behavioral therapy for smoking cessation and anxiety; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.; Enhanced standard smoking cessation treatment and NRT.
Other intervention name(s): QUESTT; Enhanced Treatment as Usual (ETAU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotine dependence; Smoking, cessation; Quitting; Anxiety symptoms; Cognitive-behavioral therapy