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Hatha Yoga for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01633632
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.

Condition or disease Intervention/treatment
Smoking Cessation Behavioral: Hatha yoga Behavioral: Cognitive behavioral therapy

Detailed Description:

While many smoking cessation interventions have been studied, even the most successful interventions result in less than 40% abstinence from smoking at 6 months. Most people attempt to quit multiple times before maintaining long-term abstinence from tobacco. Research into interventions to improve quit rates and decrease smoking prevalence is a high priority for multiple organizations. Yoga is an attractive non-pharmacological option because it can be used safely during pregnancy and lactation, can be combined with other pharmacologic and non-pharmacologic treatments, and can be continued well past the smoking cessation date to combat withdrawal symptoms and cravings. There is a critical need for innovative and effective methods for tobacco control that focus on both prevention and cessation.

This project will be broken into two stages. The first stage will aim to pilot test yoga techniques for feasibility and acceptability. Recruitment and retention strategies will be tested and participant satisfaction will be evaluated. Preliminary measures of smoking abstinence and withdrawal symptoms will be conducted.

The second stage of this study will be a randomized trial to compare smoking abstinence with cognitive behavioral therapy (CBT), CBT + yoga, or yoga alone.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation
Study Start Date : August 2012
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Cognitive behavioral therapy
This group will receive a standardized, 8-session cognitive behavioral therapy course that is offered to the public at our practice.
Behavioral: Cognitive behavioral therapy
8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.
Experimental: Cognitive behavioral therapy + yoga
This group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga.
Behavioral: Hatha yoga
30 minutes of instruction in Hatha yoga will be provided for 8 sessions.
Behavioral: Cognitive behavioral therapy
8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.
Experimental: Hatha yoga
This group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt
Behavioral: Hatha yoga
30 minutes of instruction in Hatha yoga will be provided for 8 sessions.


Outcome Measures

Primary Outcome Measures :
  1. Point prevalence abstinence from smoking [ Time Frame: End of intervention (week 7) ]
    Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention.


Secondary Outcome Measures :
  1. Abstinence from smoking [ Time Frame: 3 and 6 months ]
    Prolonged abstinence defined as no smoking after the identified "quit date" and point prevalence abstinence (no smoking in the past 7 days) will be measured. Measured by self-report.

  2. Change in weight [ Time Frame: End of intervention (week 7) ]
    Change in weight from baseline to week 7

  3. Signs and symptoms of nicotine withdrawal [ Time Frame: Weeks 1-7 during intervention period ]
    Survey will be administered weekly during class sessions


Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19 years or older
  • Smoker of 5 or more cigarettes per day
  • Willing and physically able to participate in yoga
  • Not currently practicing Hatha yoga.

Exclusion Criteria:

  • Use of smokeless tobacco
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633632


Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Amy Mayer, OTD, OTR/L Creighton University
More Information

Publications:
Burns TL, Mayer AE, Washington-Krauth SM, Walters RW, Arouni AJ. Design and Feasibility of a Hatha Yoga Intervention for Smoking Cessation. Journal of Smoking Cessation 2014; doi:10.1017/jsc.2014.21.

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01633632     History of Changes
Other Study ID Numbers: 12-16438/13-16721
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Creighton University:
Smoking cessation
Yoga
Cognitive behavioral therapy