Yoga for Women Attempting Smoking Cessation

NCT ID: NCT00492310

Last Updated: 2010-07-20

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers.

Detailed Description

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Smoking is the leading preventable cause of morbidity and mortality among women in the US. Quitting smoking may be especially problematic for women. As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise which our previous research has shown to be an effective addition to smoking cessation. Yoga may also offer other benefits that may make it an especially effective complimentary treatment for women who are attempting to quit smoking.

In this study we will recruit two cohorts of 30 women smokers and provide cognitive-behavioral therapy for smoking cessation once weekly for 12 weeks. In addition, participants will be randomly assigned them to receive either; (1) Yoga or (2) a Wellness program (contact-control), twice weekly during the program. All participants will be assessed for changes in smoking behavior, psychosocial variables relevant to smoking cessation and other psychological constructs that may act as mechanisms of action (mediators) of yoga and smoking cessation. These variables include; weight concerns, perceived stress, mindfulness, self-esteem, quality of life and group cohesion. Interviews will be used to collect qualitative data at the end of each cohort. The proposed study is designed to provide information necessary to establish several research fundamentals necessary to support a full scale efficacy trial. These include: 1) establishing intervention feasibility and acceptability in the target population, 2) piloting recruitment and retention procedures and identifying barriers to participation, 3) obtaining qualitative feedback from participants to enhance treatment content and/or design, 4) establishing anticipated effect size estimates, and 5) identifying likely mechanisms of action that may be responsible for intervention efficacy.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cognitive-behavioral smoking cessation with yoga

Group Type EXPERIMENTAL

yoga

Intervention Type BEHAVIORAL

vinyasa yoga

cognitive therapy

Intervention Type BEHAVIORAL

cognitive behavioral therapy once weekly

yoga

Intervention Type BEHAVIORAL

vinyasa yoga twice weekly with smoking cessation once weekly

2

smoking cessation with twice weekly wellness program

Group Type ACTIVE_COMPARATOR

cognitive therapy

Intervention Type BEHAVIORAL

cognitive behavioral therapy once weekly

wellness

Intervention Type BEHAVIORAL

wellness program with smoking cessation

Interventions

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yoga

vinyasa yoga

Intervention Type BEHAVIORAL

cognitive therapy

cognitive behavioral therapy once weekly

Intervention Type BEHAVIORAL

yoga

vinyasa yoga twice weekly with smoking cessation once weekly

Intervention Type BEHAVIORAL

wellness

wellness program with smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Female, Age 18-65, Cigarette smoking 10 or more per day for more than 1 year, sedentary (not exercising more than 2 days per week)

Exclusion Criteria

Major depression, Hypertension, Current yoga practice, Current mind/body therapies
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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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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The Miriam Hospital

Principal Investigators

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Beth C Bock, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

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)

Bock BC, Morrow KM, Becker BM, Williams DM, Tremont G, Gaskins RB, Jennings E, Fava J, Marcus BH. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study. BMC Complement Altern Med. 2010 Apr 29;10:14. doi: 10.1186/1472-6882-10-14.

Reference Type DERIVED
PMID: 20429895 (View on PubMed)

Other Identifiers

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R21AT003669-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21AT003669-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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