NCT01809678

Brief Summary

This study examines the efficacy of yoga as a complementary therapy for smoking cessation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 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

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

4 years

First QC Date

March 11, 2013

Last Update Submit

July 13, 2021

Conditions

Keywords

SmokingTobaccoYoga

Outcome Measures

Primary Outcomes (1)

  • Smoking abstinence

    Abstinence from smoking at 1-year post treatment

    One year

Study Arms (2)

Smoking Cessation plus Yoga

EXPERIMENTAL

Twice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.

Behavioral: Smoking CessationBehavioral: Yoga

Smoking Cessation plus Wellness

ACTIVE COMPARATOR

Twice-weekly, 1-hour Wellness classes given on a variety of health topics twice weekly to match schedule of the yoga classes, plus 1-hour per week of cognitive-behavioral smoking cessation

Behavioral: Smoking CessationOther: Wellness

Interventions

Once weekly program of cognitive-behavioral therapy for smoking cessation

Smoking Cessation plus WellnessSmoking Cessation plus Yoga
YogaBEHAVIORAL

Twice weekly program of 1-hour Iyengar yoga classes

Smoking Cessation plus Yoga

Twice weekly program of 1-hour wellness classes on a variety of health topics.

Smoking Cessation plus Wellness

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older (physician clearance for age \> 65)
  • English-speaking
  • Currently Healthy
  • Smoking smoked 5 or more cigarettes/day
  • Must accept randomization procedure
  • BMI\< 40
  • Will be Living in RI/MA/CT for next year

You may not qualify if:

  • Participated in any Yoga, Tai Chi, Qi Gong or Mindfulness-based therapy program twice in the past month or 10 times within the past year
  • MD refused consent or Unable to obtain MD consent
  • Unable to attend program due to work or home schedule
  • Currently using medications or in active treatment to quit smoking
  • Currently or planned participation in research or treatment programs that would interfere with this study
  • Presence of health conditions that would make participation in yoga difficult or dangerous
  • Cardiovascular disease
  • Stroke/TIA
  • Chest pain with physical activity
  • Current or recent (\< 6 months) cancer treatment
  • Uncontrolled Hypertension
  • Untreated major depression or hospitalization \< six months
  • Bone joint problems
  • Liver or Kidney Disease
  • Fainting within the past year
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (5)

  • Thind H, Jennings E, Fava JL, Sillice MA, Becker BM, Hartman SJ, Bock BC. Differences between Men and Women Enrolling in Smoking Cessation Programs Using Yoga as a Complementary Therapy. J Yoga Phys Ther. 2016;6(3):245. doi: 10.4172/2157-7595.1000245. Epub 2016 Jun 15.

    PMID: 27683623BACKGROUND
  • Bock BC, Rosen RK, Fava JL, Gaskins RB, Jennings E, Thind H, Carmody J, Dunsiger SI, Gidron N, Becker BM, Marcus BH. Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial. Contemp Clin Trials. 2014 Jul;38(2):321-32. doi: 10.1016/j.cct.2014.06.003. Epub 2014 Jun 14.

    PMID: 24937018BACKGROUND
  • Bock BC, Dunsiger SI, Rosen RK, Thind H, Jennings E, Fava JL, Becker BM, Carmody J, Marcus BH. Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial. Nicotine Tob Res. 2019 Oct 26;21(11):1517-1523. doi: 10.1093/ntr/nty212.

  • Bock BC, Thind H, Dunsiger S, Fava JL, Jennings E, Becker BM, Marcus BH, Rosen RK, Sillice MA. Who Enrolls in a Quit Smoking Program with Yoga Therapy? Am J Health Behav. 2017 Nov 1;41(6):740-749. doi: 10.5993/AJHB.41.6.8.

  • Rosen RK, Thind H, Jennings E, Guthrie KM, Williams DM, Bock BC. "Smoking Does Not Go With Yoga:" A Qualitative Study of Women's Phenomenological Perceptions During Yoga and Smoking Cessation. Int J Yoga Therap. 2016 Jan;26(1):33-41. doi: 10.17761/1531-2054-26.1.33.

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

YogaHealth

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychologist

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

July 1, 2012

Primary Completion

July 1, 2016

Study Completion

June 1, 2017

Last Updated

July 19, 2021

Record last verified: 2021-07

Locations