NCT01633632

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

2.7 years

First QC Date

July 2, 2012

Last Update Submit

December 10, 2015

Conditions

Keywords

Smoking cessationYogaCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Abstinence from smoking

    3 and 6 months

  • Change in weight

    End of intervention (week 7)

  • Signs and symptoms of nicotine withdrawal

    Weeks 1-7 during intervention period

Study Arms (3)

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.

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.

Behavioral: Hatha yogaBehavioral: Cognitive behavioral therapy

Hatha yoga

EXPERIMENTAL

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

Behavioral: Hatha yoga

Interventions

Hatha yogaBEHAVIORAL

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

Cognitive behavioral therapy + yogaHatha yoga

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

Cognitive behavioral therapyCognitive behavioral therapy + yoga

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of smokeless tobacco

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Amy Mayer, OTD, OTR/L

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 4, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations