Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
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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 |
- 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 |
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| Contact: Laura MacPherson, PhD | 301-405-4188 | umdquit@gmail.com |
| 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 | |
| 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 May 16, 2013