Hatha Yoga for Smoking Cessation

NCT ID: NCT01633632

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Smoking cessation Yoga Cognitive behavioral therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive behavioral therapy

This group will receive a standardized, 8-session cognitive behavioral therapy course that is offered to the public at our practice.

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.

Cognitive behavioral therapy + yoga

This group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga.

Group Type EXPERIMENTAL

Hatha yoga

Intervention Type BEHAVIORAL

30 minutes of instruction in Hatha yoga will be provided for 8 sessions.

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.

Hatha yoga

This group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt

Group Type EXPERIMENTAL

Hatha yoga

Intervention Type BEHAVIORAL

30 minutes of instruction in Hatha yoga will be provided for 8 sessions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hatha yoga

30 minutes of instruction in Hatha yoga will be provided for 8 sessions.

Intervention Type BEHAVIORAL

Cognitive behavioral therapy

8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Creighton University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy Mayer, OTD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Creighton University

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-16438/13-16721

Identifier Type: -

Identifier Source: org_study_id