Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

Phase 2

Completed

• Conditions: Cigarette Smoking
• Interventions: Behavioral: Standard Treatment; Behavioral: Behavioral Activation Treatment for Smoking; Drug: Transdermal Nicotine Patch

• Registration Number: NCT01199380
• Lead Sponsor: University of Maryland, College Park

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2020-08-24
• Results First Submitted QC: 2020-09-12
• Results First Posted: 2020-09-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment (ST)	Standard Treatment	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 Activation for Smoking	Behavioral Activation Treatment for Smoking	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.
Standard Treatment (ST)	Transdermal Nicotine Patch	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 Activation for Smoking	Transdermal Nicotine Patch	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland, College Park; 🇺🇸 College Park, Maryland, United States