Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically
      reduce cessation rates among both community and clinical samples. Previous research has
      examined the efficacy of cognitive-behavioral treatment for individuals with a history of
      major depressive disorder (MDD) in standard cessation treatment. A broader health impact can
      be achieved by targeting individuals with current elevated depressive symptoms to address
      their association with cessation failure. Thus the objective of the present proposal is to
      conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation
      intervention to standard treatment among a similar community sample of 200 adult smokers with
      elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and
      the larger sample size will allow for more complex analysis of cessation outcomes.
    

Detailed description: 
      This will be a Stage II randomized control trial to examine the efficacy of behavioral
      activation treatment for smoking (BATS) vs. standard smoking cessation treatment (ST). We
      will recruit 200 smokers with elevated depressive symptoms who will be randomized into one of
      two treatment groups. Treatment will be delivered in group format across both the BATS (n =
      100) and ST condition (n = 100). All participants will receive 8 weeks of transdermal
      nicotine patch in addition to their assigned treatment group. We intend to compare the BA
      treatment for smoking (BATS) to a standard smoking cessation intervention (ST)on abstinence
      and relapse outcomes. In addition we will examine to what extent depressive symptoms and
      reward sensitivity prior to quit date will mediate the effects of BATS on improved smoking
      cessation outcomes relative to ST.
    

Intervention name(s): Standard Treatment; Behavioral Activation Treatment for Smoking; Transdermal Nicotine Patch
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Participants will receive a standard, group smoking cessation treatment, based on the most recent clinical practice guideline for treating tobacco use from the U.S. Department of Health and Human Services. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events as a means to equate for time spent on daily activity monitoring in the BATS condition.; BATS is focused on identifying life areas, values, and daily activities to help one live according to his or her values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period.; 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
Other intervention name(s): ST; BATS; Nicoderm CQ
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Smoking, Smoking Cessation