Study Results
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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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2007-08-31
2011-03-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Cognitive-behavioral smoking cessation with yoga
yoga
vinyasa yoga
cognitive therapy
cognitive behavioral therapy once weekly
yoga
vinyasa yoga twice weekly with smoking cessation once weekly
2
smoking cessation with twice weekly wellness program
cognitive therapy
cognitive behavioral therapy once weekly
wellness
wellness program with smoking cessation
Interventions
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yoga
vinyasa yoga
cognitive therapy
cognitive behavioral therapy once weekly
yoga
vinyasa yoga twice weekly with smoking cessation once weekly
wellness
wellness program with smoking cessation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
The Miriam Hospital
OTHER
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
Countries
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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.
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.
Other Identifiers
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