Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: Standard Treatment; Drug: Transdermal Nicotine Patch; Behavioral: Behavioral Activation Treatment for Smoking

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland, College Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment (ST); 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; 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.; Other Names: ST; Drug: Transdermal Nicotine Patch; 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 Names: Nicoderm CQ
Experimental: Behavioral Activation 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.	Drug: Transdermal Nicotine Patch; 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 Names: Nicoderm CQ; Behavioral: Behavioral Activation Treatment for Smoking; 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.; Other Names: BATS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Maryland, College Park
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Smoking, Smoking Cessation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: DA018730; 5R01DA018730-07 (U.S. NIH Grant/Contract)