Hatha Yoga for Smoking Cessation

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

Detailed Description
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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.

Official Title
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Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Hatha yoga
* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive behavioral therapy<br>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<br>* 8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.<br>|
| Experimental: Cognitive behavioral therapy + yoga<br>This group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga. | Behavioral: Hatha yoga<br>* 30 minutes of instruction in Hatha yoga will be provided for 8 sessions.<br>Behavioral: Cognitive behavioral therapy<br>* 8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.<br>|
| Experimental: Hatha yoga<br>This group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt | Behavioral: Hatha yoga<br>* 30 minutes of instruction in Hatha yoga will be provided for 8 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence abstinence from smoking | Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention. | End of intervention (week 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from smoking | 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. | 3 and 6 months | 
| Change in weight | Change in weight from baseline to week 7 | End of intervention (week 7) | 
| Signs and symptoms of nicotine withdrawal | Survey will be administered weekly during class sessions | Weeks 1-7 during intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Yoga, Cognitive behavioral therapy