Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: Standard Treatment
* Behavioral: Behavioral Activation Treatment for Smoking
* Drug: Transdermal Nicotine Patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment (ST)<br>Participants will receive a standard, group smoking cessation treatment equated for contact time, based on the most recent clinical practice guideline for treating tobacco. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will complete between group exercises and 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. Participants will also receive 8 weeks of the transdermal nicotine patch. | Behavioral: Standard Treatment<br>* 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.<br>* Other names: ST;Drug: Transdermal Nicotine Patch<br>* 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.<br>* Other names: Nicoderm CQ;|
| Experimental: Behavioral Activation for Smoking<br>Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch. | Behavioral: Behavioral Activation Treatment for Smoking<br>* 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.<br>* Other names: BATS;Drug: Transdermal Nicotine Patch<br>* 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.<br>* Other names: Nicoderm CQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date | 7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt | 52 weeks post quit date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking Cessation