Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Not Applicable

Completed

Conditions: Smoking
Tobacco Use Cessation

Interventions: Behavioral: MBAT Group Therapy
Drug: Nicotine
Behavioral: Group Therapy
Behavioral: Individual Therapy

Registration Number: NCT00297479

Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary: The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

Detailed Description: This 3-group randomized clinical trial will develop and evaluate a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness reflects a purposeful control of attention and can be learned through training in attentional control procedures.

Current cigarette smokers (N=550; 400 in formal study; up to 80-150 pilot) will be randomly assigned to Usual Care (UC), Standard Treatment (ST) or MBAT. UC will be four 5-10 minute counseling sessions following the problem-solving approach in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline). ST is a standard smoking cessation group program using a problem-solving/coping skills approach. MBAT is a group smoking cessation program derived from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. MBAT will not alter the basic mindfulness approach used in MBCT and MBSR, but will replace depression-related material with smoking cessation strategies from the Guideline. All participants will receive nicotine patches and self-help materials. MBAT mechanisms and effects will be assessed using "implicit" cognitive psychological measures and computer-administered questionnaires. Participants will be tracked from baseline through 4 (UC) or 8 (ST and MBAT) treatment visits and follow-up visits 1 and 23 weeks post-treatment.

The overarching goals are to evaluate MBAT's efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

Primary specific aims are to:

1. Examine the effects of MBAT on abstinence rates

2. Examine the effects of MBAT on mindfulness/metacognitive awareness, attentional control, smoking automaticity, smoking associations in memory, negative affect, depression, stress, affect regulation expectancies, self-efficacy, withdrawal, and coping across the pre- and post-cessation period, and whether these variables mediate MBAT effects on abstinence.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 650

Inclusion Criteria

Age 18 or above
Current smoker with a history of at least five cigarettes/day for the past year
Motivated to quit within the next 30 days (preparation stage)
Participants must provide a viable home address and a functioning home telephone number
Can read and write in English
Register "8" or more on a carbon monoxide breath test
Provide viable collateral contact information

Exclusion Criteria

Contraindication for nicotine patch use
Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
Use of bupropion or nicotine patch replacement products other than the study patches
Pregnancy or lactation
Another household member enrolled in the study
Active substance dependence (exclusive of nicotine dependence)
Current psychiatric disorder; current use of psychotropic medication
Participation in a smoking cessation program or study during the past 90 days

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Treatment Group (MBAT)	MBAT Group Therapy	MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.
Standard Care Group	Group Therapy	Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Usual Care Group	Individual Therapy	Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Usual Care Group	Nicotine	Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Standard Care Group	Nicotine	Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Mindfulness-Based Treatment Group (MBAT)	Nicotine	MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Smoking Abstinence	4 weeks post quit day (one week following the end of treatment)	Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
Smoking Abstinence	4 weeks post quit day (one week following the end of treatment)	Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

Secondary Outcome Measures