Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01199380
First received: September 3, 2010
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Behavioral: Standard Treatment
Behavioral: Behavioral Activation Treatment for Smoking
Drug: Transdermal Nicotine Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests, and self-report [ Time Frame: 12 months post quit date ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 Name: 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 Name: Nicoderm CQ
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.
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 Name: BATS
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 Name: Nicoderm CQ

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199380

Contacts
Contact: Laura MacPherson, PhD 301-405-4188 umdquit@gmail.com

Locations
United States, Maryland
University of Maryland, College Park Recruiting
College Park, Maryland, United States, 20742
Contact: Laura MacPherson       umdquit@gmail.com   
Principal Investigator: Laura MacPherson, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Laura MacPherson, PhD University of Maryland
  More Information

No publications provided

Responsible Party: Dr. Laura MacPherson, University of Maryland
ClinicalTrials.gov Identifier: NCT01199380     History of Changes
Other Study ID Numbers: DA018730
Study First Received: September 3, 2010
Last Updated: December 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Smoking, Smoking Cessation

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014