Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297479
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2006-02-24
Brief Title:
Group Therapy for Nicotine Dependence Mindfulness and Smoking
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Group Therapy for Nicotine Dependence
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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 MBATs 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 N550 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-solvingcoping 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 MBATs efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBATs impact on abstinence
Primary specific aims are to
1 Examine the effects of MBAT on abstinence rates
2 Examine the effects of MBAT on mindfulnessmetacognitive 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
Current cigarette smokers N550 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-solvingcoping 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 MBATs efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBATs impact on abstinence
Primary specific aims are to
1 Examine the effects of MBAT on abstinence rates
2 Examine the effects of MBAT on mindfulnessmetacognitive 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA018875 | NIH | None | None |
| NCI-2012-02081 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchR01DA018875 |