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临床试验/NCT00297479
NCT00297479已完成不适用

Group Therapy for Nicotine Dependence

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
650
试验地点
1
主要终点
Number of Participants With Smoking Abstinence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Mindfulness-Based Treatment Group (MBAT)

Experimental

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.

干预措施: MBAT Group Therapy (Behavioral)

Mindfulness-Based Treatment Group (MBAT)

Experimental

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.

干预措施: Nicotine (Drug)

Standard Care Group

Active Comparator

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

干预措施: Nicotine (Drug)

Standard Care Group

Active Comparator

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

干预措施: Group Therapy (Behavioral)

Usual Care Group

Active Comparator

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

干预措施: Nicotine (Drug)

Usual Care Group

Active Comparator

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

干预措施: Individual Therapy (Behavioral)

结局指标

主要结局

Number of Participants With Smoking Abstinence

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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