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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03995225
Other study ID # 2000025082
Secondary ID 1R34AT010365-01
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2020
Est. completion date March 3, 2022

Study information

Verified date February 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date March 3, 2022
Est. primary completion date March 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Smartband automatic smoking detection combined with brief mindfulness interventions
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.

Locations

Country Name City State
United States Yale School of Medicine New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Adherence to Wearing the Smartband Percent of days spent wearing the smartband. 60 days
Primary Adherence to Answering Smartband Notifications of Smoking Events Percent of smoking notifications answered 60 days
Primary 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
Primary Adherence to Completing Mindfulness Exercises Percent of mindfulness exercises (RAIN, mindful smoking) completed 60 days
Primary 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
Primary 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 Number of Participants With Self-reported Abstinence From Smoking 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) 7 days
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