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Completed

NCT Number: NCT01199380

Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

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.

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Key information

Conditions

Cigarette Smoking Behavior Health Behavior Smoking Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Maryland, College Park

College Park, Maryland, 20742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: BATS

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.

Other names: Nicoderm CQ

Primary outcomes

  1. Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date

    Time frame: 52 weeks post quit date

    7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2010
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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