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Smartband Mindfulness Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995225
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Smartband automatic smoking detection and brief mindfulness interventions Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartband/Smartphone-based Automatic Smoking Detection and Real Time Mindfulness Intervention
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Smokers
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.
Behavioral: Smartband automatic smoking detection and brief mindfulness interventions
Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions




Primary Outcome Measures :
  1. Fidelity of detecting smoking episodes [ Time Frame: 21 days ]
    Percent of smoking episodes detected and the rate of false alarms in the first 21 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes.

  2. Fidelity of delivering mindfulness exercises triggered by smoking [ Time Frame: 7 days ]
    Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms in the next 7 days of the study 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).

  4. Adherence to wearing the smartband [ Time Frame: 60 days ]
    Percent of time 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 ]
    Percent of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered.

  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.

  9. Acceptability of intervention - user experiences survey [ Time Frame: 60 days ]
    Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) - One survey


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995225


Contacts
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Contact: Kathleen A Garrison, PhD 203-737-6232 kathleen.garrison@yale.edu

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Kathleen A Garrison, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03995225    
Other Study ID Numbers: 200025082
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No