NCT02055326

Brief Summary

The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

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

Study Start

First participant enrolled

September 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

February 5, 2014

Status Verified

January 1, 2014

Enrollment Period

1.4 years

First QC Date

February 3, 2014

Last Update Submit

February 4, 2014

Conditions

Keywords

Smokingyogamenintervention

Outcome Measures

Primary Outcomes (1)

  • Smoking abstinence

    7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up

    7 days

Study Arms (2)

Yoga

EXPERIMENTAL

One-hour sessions of twice weekly yoga for 8 weeks.

Behavioral: Cognitive Behavioral Therapy for Smoking CessationBehavioral: Yoga

Health & Wellness

ACTIVE COMPARATOR

8 week program of health \& wellness classes, materials and handouts. Topics included healthy eating, cancer prevention and cardiovascular disease prevention.

Behavioral: Cognitive Behavioral Therapy for Smoking CessationBehavioral: Health & Wellness

Interventions

one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Health & WellnessYoga
YogaBEHAVIORAL

One hour, twice weekly for 8 weeks of vinyasa yoga

Yoga

Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.

Health & Wellness

Eligibility Criteria

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

You may qualify if:

  • male
  • age 18 -65
  • daily smoker, 5 or more cigarettes/day
  • generally healthy
  • able to exercise safely

You may not qualify if:

  • female
  • hypertension
  • current or recent history of medication use for major depression
  • participation in yoga classes within the past year
  • current or \>1 year prior experience with mind/body therapies
  • currently participating in regular exercise classes
  • currently enrolled in quit smoking program
  • currently using quit smoking medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking CessationSmokingMultiple Endocrine Neoplasia Type 1

Interventions

Cognitive Behavioral TherapyYogaHealth

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesPopulation Characteristics

Study Design

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

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

September 1, 2009

Primary Completion

February 1, 2011

Study Completion

July 1, 2011

Last Updated

February 5, 2014

Record last verified: 2014-01

Locations