Hatha Yoga for Smoking Cessation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01633632
First received: July 2, 2012
Last updated: March 27, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Point prevalence abstinence from smoking [ Time Frame: End of intervention (week 7) ] [ Designated as safety issue: No ]
    Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention.


Secondary Outcome Measures:
  • Abstinence from smoking [ Time Frame: 3 and 6 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 7 days) will be measured. Measured by self-report.

  • Change in weight [ Time Frame: End of intervention (week 7) ] [ Designated as safety issue: No ]
    Change in weight from baseline to week 7

  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633632

Contacts
Contact: Tammy L Burns, PharmD 402-280-4566 tammyburns@creighton.edu
Contact: Amy Matthews, OTD 402-280-5955 amatt@creighton.edu

Locations
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         
Sponsors and Collaborators
Creighton University
Investigators
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: 12-16438/13-16721
Study First Received: July 2, 2012
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014