Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

Cigarette Smoking Clinical Trial

Official title:

Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199380
• Other study ID #: DA018730
• Secondary ID: 5R01DA018730-07
• Status: Completed
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: May 2016

Study information

• Verified date: May 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
United States	University of Maryland, College Park	College Park	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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