Smartband Mindfulness Study
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|ClinicalTrials.gov Identifier: NCT03995225|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Smartband automatic smoking detection and brief mindfulness interventions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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).
- Adherence to wearing the smartband [ Time Frame: 60 days ]Percent of time spent wearing the smartband
- Adherence to answering smartband notifications of smoking events [ Time Frame: 60 days ]Percent of smoking notifications answered
- 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.
- Adherence to completing mindfulness exercises [ Time Frame: 60 days ]Percent of mindfulness exercises (RAIN, mindful smoking) completed
- 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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995225
|Contact: Kathleen A Garrison, PhDfirstname.lastname@example.org|
|Principal Investigator:||Kathleen A Garrison, PhD||Yale University|