Yoga for Men Attempting Smoking Cessation

NCT ID: NCT02055326

Last Updated: 2014-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.

Detailed Description

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Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health \& wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Yoga

One-hour sessions of twice weekly yoga for 8 weeks.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Smoking Cessation

Intervention Type BEHAVIORAL

one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Yoga

Intervention Type BEHAVIORAL

One hour, twice weekly for 8 weeks of vinyasa yoga

Health & Wellness

8 week program of health \& wellness classes, materials and handouts. Topics included healthy eating, cancer prevention and cardiovascular disease prevention.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Smoking Cessation

Intervention Type BEHAVIORAL

one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Health & Wellness

Intervention Type BEHAVIORAL

Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.

Interventions

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Cognitive Behavioral Therapy for Smoking Cessation

one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Intervention Type BEHAVIORAL

Yoga

One hour, twice weekly for 8 weeks of vinyasa yoga

Intervention Type BEHAVIORAL

Health & Wellness

Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* male
* age 18 -65
* daily smoker, 5 or more cigarettes/day
* generally healthy
* able to exercise safely

Exclusion Criteria

* female
* hypertension
* current or recent history of medication use for major depression
* participation in yoga classes within the past year
* current or \>1 year prior experience with mind/body therapies
* currently participating in regular exercise classes
* currently enrolled in quit smoking program
* currently using quit smoking medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

Reference Type DERIVED
PMID: 35420700 (View on PubMed)

Other Identifiers

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AT003669-02S1

Identifier Type: -

Identifier Source: org_study_id

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