Clinical trial NCT01199380: Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
Official title: Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Keywords: Smoking, Smoking Cessation
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2010-09-10
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years of age
* A regular smoker for at least one year
* Currently smoking an average of at least 10 cigarettes per day
* Want to quit smoking
* Report current elevated depressive symptoms

Exclusion Criteria:

* Current Axis I disorder
* Psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
* Current use of psychotropic medication or participation in any form of psychotherapy
* A history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
* Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt

Primary outcomes:
measure: Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date
timeFrame: 52 weeks post quit date
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
Study officials:
affiliation: University of Maryland
name: Laura MacPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: