Hatha Yoga for Smoking Cessation
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Purpose
The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.
| Condition | Intervention |
|---|---|
|
Smoking Cessation |
Behavioral: Hatha yoga Behavioral: Cognitive behavioral therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation |
- Point prevalence abstinence from smoking [ Time Frame: 6 months ] [ Designated as safety issue: No ]Abstinence from smoking as measured by expired carbon monoxide at 6 months post-intervention.
- Abstinence from smoking [ Time Frame: 0, and 3 months ] [ Designated as safety issue: No ]Prolonged abstinence defined as no smoking after the identified "quit date" and point prevalence abstinence (no smoking in the past 14 days) will be measured. Measured through expired carbon monoxide and verified by self-report.
- Change in weight [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Change in weight from baseline
- Signs and symptoms of nicotine withdrawal [ Time Frame: Weeks 1-7 during intervention period ] [ Designated as safety issue: No ]Survey will be administered weekly during class sessions
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Tammy L Burns, PharmD | 402-280-4566 | tammyburns@creighton.edu |
| Contact: Amy Matthews, OTD | 402-280-5955 | amatt@creighton.edu |
| United States, Nebraska | |
| Creighton University | Recruiting |
| Omaha, Nebraska, United States, 68178 | |
| Contact: Tammy L Burns, PharmD, BCPS 402-280-4566 tammyburns@creighton.edu | |
| Contact: Amy Matthews, OTD, OTR/L 402-280-5955 amatt@creighton.edu | |
| Principal Investigator: Amy Matthews, OTD, OTR/L | |
| Sub-Investigator: Tammy L Burns, PharmD, BCPS | |
| Sub-Investigator: Shavonne Washington-Krauth, MA | |
| Sub-Investigator: Amy J Arouni, MD | |
| Sub-Investigator: Syed M Mohiuddin, MD | |
| Sub-Investigator: Paul Turner, PhD | |
| Principal Investigator: | Amy Matthews, OTD, OTR/L | Creighton University |
More Information
No publications provided
| Responsible Party: | Creighton University |
| ClinicalTrials.gov Identifier: | NCT01633632 History of Changes |
| Other Study ID Numbers: | 12-16438 |
| Study First Received: | July 2, 2012 |
| Last Updated: | August 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Creighton University:
|
Smoking cessation Yoga Cognitive behavioral therapy |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on June 17, 2013