Smoking CessationNCT01633632
Hatha Yoga for Smoking Cessation
A study testing Hatha yoga and Cognitive behavioral therapy in people with Smoking Cessation, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Hatha yoga and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Use of smokeless tobacco
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation
The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Hatha yoga, Cognitive behavioral therapy
- Keywords
- Smoking cessation, Yoga, Cognitive behavioral therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha yogaBehavioural
30 minutes of instruction in Hatha yoga will be provided for 8 sessions.
Cognitive behavioral therapyBehavioural
8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Active comparator | This group will receive a standardized, 8-session cognitive behavioral therapy course that is offered to the public at our practice. Receives: Behavioral: Cognitive behavioral therapy |
| Cognitive behavioral therapy + yoga | Experimental | This group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga. Receives: Behavioral: Hatha yoga; Behavioral: Cognitive behavioral therapy |
| Hatha yoga | Experimental | This group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt Receives: Behavioral: Hatha yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence from smoking
Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention.
Measured: End of intervention (week 7)
Secondary outcomes (3)
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.
Measured: 3 and 6 months
Change in weight
Change in weight from baseline to week 7
Measured: End of intervention (week 7)
Signs and symptoms of nicotine withdrawal
Survey will be administered weekly during class sessions
Measured: Weeks 1-7 during intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Mayer, OTD, OTR/L, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633632
- Sponsor's protocol ID
- 12-16438/13-16721
- Status last verified
- Dec 2015
- First submitted
- 2 Jul 2012
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01633632
- Acronym / sponsor ID
- 12-16438/13-16721
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Yoga, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Active comparator | Behavioral: Cognitive behavioral therapyThis group will receive a standardized, 8-session cognitive behavioral therapy course that is offered to the public at our practice. |
| Cognitive behavioral therapy + yoga | Experimental | Behavioral: Hatha yoga, Behavioral: Cognitive behavioral therapyThis group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga. |
| Hatha yoga | Experimental | Behavioral: Hatha yogaThis group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Use of smokeless tobacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha yoga30 minutes of instruction in Hatha yoga will be provided for 8 sessions. | Behavioural | Cognitive behavioral therapy + yoga, Hatha yoga |
| Cognitive behavioral therapy8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum. | Behavioural | Cognitive behavioral therapy, Cognitive behavioral therapy + yoga |
Primary outcome
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.
3 secondary outcomes
Abstinence from smoking
Time frame: 3 and 6 months
Change in weight
Time frame: End of intervention (week 7)
Signs and symptoms of nicotine withdrawal
Time frame: Weeks 1-7 during intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Results publicationBurns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Mayer, OTD, OTR/L principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha yoga and Cognitive behavioral therapy in people with Smoking Cessation, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence from smoking (time frame: End of intervention (week 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.