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Yoga for Women Attempting Smoking Cessation

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Lifespan

Status and phase

Unknown
Phase 3

Conditions

Smoking

Treatments

Behavioral: yoga
Behavioral: wellness
Behavioral: cognitive therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00492310
R21AT003669-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

1
Experimental group
Description:
Cognitive-behavioral smoking cessation with yoga
Treatment:
Behavioral: yoga
Behavioral: cognitive therapy
Behavioral: yoga
2
Active Comparator group
Description:
smoking cessation with twice weekly wellness program
Treatment:
Behavioral: cognitive therapy
Behavioral: wellness

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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