Skip to main content
OpenTrials
Completed

NCT Number: NCT03995225

Smartband Mindfulness Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

About this study

This study will test the feasibility of using a smartband to detect and track smoking and deliver brief smoking cessation interventions by smartphone app in real time. Smokers will wear a smartband to detect and notify them of smoking for 21 days and obtain individual smoking profiles; detected smoking will then trigger a "mindful smoking" exercise for the next 7 days leading up to their quit date at 30 days; after which another mindfulness exercise ("RAIN": recognize, accept, investigate and note cravings rather than smoke) will be delivered prior to each predicted smoking episode according to their individual smoking profile for 30 days post-quit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Fidelity of Detecting Smoking Episodes

    Time frame: 60 days

    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.

  2. Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking

    Time frame: 39 days

    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.

  3. Timeliness of Delivering RAIN Exercise

    Time frame: 30 days

    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.

  4. Adherence to Wearing the Smartband

    Time frame: 60 days

    Percent of days spent wearing the smartband.

  5. Adherence to Answering Smartband Notifications of Smoking Events

    Time frame: 60 days

    Percent of smoking notifications answered

  6. Adherence to Answering Ecological Momentary Assessment Items

    Time frame: 60 days

    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.

  7. Adherence to Completing Mindfulness Exercises

    Time frame: 60 days

    Percent of mindfulness exercises (RAIN, mindful smoking) completed

  8. Acceptability of Intervention - Helpfulness of Mindfulness Exercises

    Time frame: 60 days

    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.

  9. Acceptability of Intervention - User Experiences Survey

    Time frame: up to 60 days

    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.

Secondary outcomes

  1. Number of Participants With Self-reported Abstinence From Smoking

    Time frame: 7 days

    As a secondary aim we will also evaluate self-reported one-week point prevalence abstinence from smoking and prolonged abstinence from smoking (≤5 cigarettes since quit date)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Smartband/Smartphone-based Automatic Smoking Detection and Real Time Mindfulness Intervention

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2019
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.