Mechanisms of Mindfulness for Smoking Cessation

NCT02943499 | Completed Results

• 1 other identifier: 1R61AT009337-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal

  BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping

  1 month

Study Arms (2)

Active Comparator App/Training

ACTIVE COMPARATOR

This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.

Behavioral: App/Training; Device: Smartphone

Experimental App/Training

EXPERIMENTAL

This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.

Behavioral: App/Training; Device: Smartphone

Interventions

App/Training BEHAVIORAL

This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones

Active Comparator App/Training

Smartphone DEVICE

Active Comparator App/Training; Experimental App/Training

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Smoke 10+ cigarettes/day
• \< 3 months abstinence in the past year
• Have a smartphone; and motivated to quit smoking
• Score \>18 of 20 on Action subscale of the Readiness to Change Questionnaire

You may not qualify if:

• Any usage of psychotropic medication: not on a stable dosage 6+ months
• Prior participation in a mindfulness course or regular meditation practice (\>20 min/week)
• Serious psychiatric, cognitive, or medical disorder
• MRI contraindications
• Structural brain damage as well as other brain abnormalities revealed by the MRI
• Claustrophobia
• Not being fluent in English
• Recreational drug use
• Pregnant women
• History of a neurological disorder
• Current participation in a smoking study
• Adults unable to consent
• Prisoners

Sponsors & Collaborators

• Brown University: lead
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

There are several limitations, including the short duration of follow up for smoking outcomes and the specific focus on a single region of interest.

Results Point of Contact

• Title: Dr. Judson Brewer
• Organization: Brown University

judson_brewer@brown.edu

401-863-2826

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-11

Locations

US (1)