Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

NCT01199380 | Completed Phase 2 Results

• 2 other identifiers: DA0187305R01DA018730-07
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Keywords

Smoking, Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Treatment (ST)

ACTIVE COMPARATOR

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; Drug: Transdermal Nicotine Patch

Behavioral Activation for Smoking

EXPERIMENTAL

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; Drug: Transdermal Nicotine Patch

Interventions

Standard Treatment BEHAVIORAL

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.

Also known as: ST

Standard Treatment (ST)

Behavioral Activation Treatment for Smoking BEHAVIORAL

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.

Also known as: BATS

Behavioral Activation for Smoking

Transdermal Nicotine Patch DRUG

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.

Also known as: Nicoderm CQ

Behavioral Activation for Smoking; Standard Treatment (ST)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Maryland, College Park

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation

Interventions

Smoking Devices; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Laura MacPherson
• Organization: University of Maryland

lauramac.phd@gmail.com

6198578425

Study Officials

• Laura MacPherson, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Laura MacPherson

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2022
• Results First Posted: September 16, 2020

Record last verified: 2022-05

Locations

US (1)