Smartband Mindfulness Study

NCT03995225 | Completed Results

• 2 other identifiers: 20000250821R34AT010365-01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

To determine treatment fidelity for a smartband/smartphone-based smoking monitoring, notification and brief mindfulness intervention.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (9)

• Fidelity of Detecting Smoking Episodes

  Percent of smoking episodes detected and the rate of false alarms in the first 60 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes.

  60 days

• Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking

  Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms during which any detected and confirmed smoking event triggers the mindful smoking exercise.

  39 days

• Timeliness of Delivering RAIN Exercise

  Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating timeliness of RAIN exercise as moderate or higher (via real-time ecological momentary assessment). Moderate or higher indicates a better (more timely) outcome.

  30 days

• Adherence to Wearing the Smartband

  Percent of days spent wearing the smartband.

  60 days

• Adherence to Answering Smartband Notifications of Smoking Events

  Percent of smoking notifications answered

  60 days

• Adherence to Answering Ecological Momentary Assessment Items

  Percentage of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered when participants completed mindfulness exercises. That is, did the participant complete the EMA when they completed the mindfulness exercise. Measured separately for percentage of EMA answered when participants completed RAIN exercises, and percentage of EMA answered when participants completed mindful smoking exercises. Reported is the percentage of EMA answered out of the number of completed mindfulness exercises, separately for RAIN and mindful smoking.

  60 days

• Adherence to Completing Mindfulness Exercises

  Percent of mindfulness exercises (RAIN, mindful smoking) completed

  60 days

• Acceptability of Intervention - Helpfulness of Mindfulness Exercises

  Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating helpfulness as moderate or higher of participants that completed at least one mindful smoking or RAIN exercise.

  60 days

• Acceptability of Intervention - User Experiences Survey

  Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) by theme- One survey with feasibility determined by 75% of participants rating the question as moderate or higher. Below are percentage of participants with ratings of moderate or higher for each question.

  up to 60 days

Secondary Outcomes (1)

• Number of Participants With Self-reported Abstinence From Smoking

  7 days

Study Arms (1)

Smokers

EXPERIMENTAL

This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises by smartphone app. There is only one arm.

Behavioral: Smartband automatic smoking detection combined with brief mindfulness interventions

Interventions

Smartband automatic smoking detection combined with brief mindfulness interventions BEHAVIORAL

Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions and learn to work mindfully with cravings and triggers rather than smoke using RAIN prior to smoking episodes.This is a 3 step intervention.

Smokers

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Daily smokers (≥ 5 cigarettes per day)
• Daily smoker for at least 2 years
• Own an Android phone or iPhone
• Fluent in English as study content is currently only available in English
• \>18 of 20 on the Action subscale of the Readiness to Change Questionnaire

You may not qualify if:

• E-cigarette use (some days/every day)

Sponsors & Collaborators

• Yale University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Horvath M, Grutman A, O'Malley SS, Gueorguieva R, Khan N, Brewer JA, Garrison KA. Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2021 Nov 16;10(11):e32521. doi: 10.2196/32521.

  PMID: 34783663 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Kathleen A Garrison
• Organization: Yale School of Medicine

kathleen.garrison@yale.edu

415-260-8618

Study Officials

• Kathleen A Garrison, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: November 22, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: February 15, 2024
• Results First Posted: November 21, 2023

Record last verified: 2024-02

Locations

US (1)