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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01199380
Study type Interventional
Source University of Maryland, College Park
Contact
Status Completed
Phase Phase 2
Start date September 2010
Completion date May 2016

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