NCT00492310

Brief Summary

The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

2.5 years

First QC Date

June 25, 2007

Last Update Submit

July 19, 2010

Conditions

Smoking

Keywords

Smokingtobaccowomenyoga

Outcome Measures

Primary Outcomes (1)

  • smoking cessation: 7-day point prevalence abstinence

    6 months

Secondary Outcomes (1)

  • Acceptability: recruitment, retention, adherence to protocol

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Cognitive-behavioral smoking cessation with yoga

Behavioral: yogaBehavioral: cognitive therapy

2

ACTIVE COMPARATOR

smoking cessation with twice weekly wellness program

Behavioral: cognitive therapyBehavioral: wellness

Interventions

yogaBEHAVIORAL

vinyasa yoga

1
cognitive therapyBEHAVIORAL

cognitive behavioral therapy once weekly

12
wellnessBEHAVIORAL

wellness program with smoking cessation

2

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, Age 18-65, Cigarette smoking 10 or more per day for more than 1 year, sedentary (not exercising more than 2 days per week)

You may not qualify if:

  • Major depression, Hypertension, Current yoga practice, Current mind/body therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

    PMID: 35420700DERIVED

  • Bock BC, Morrow KM, Becker BM, Williams DM, Tremont G, Gaskins RB, Jennings E, Fava J, Marcus BH. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study. BMC Complement Altern Med. 2010 Apr 29;10:14. doi: 10.1186/1472-6882-10-14.

    PMID: 20429895DERIVED

MeSH Terms

Conditions

Smoking

Interventions

YogaCognitive Behavioral TherapyHealth

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPopulation Characteristics

Study Officials

  • Beth C Bock, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

US(1)