Smoking Cessation
Conditions
Brief summary
To determine treatment fidelity for a smartband/smartphone-based smoking monitoring, notification and brief mindfulness intervention.
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.
Interventions
BEHAVIORALSmartband 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention - User Experiences Survey | 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. |
| Fidelity of Detecting Smoking Episodes | 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. |
| Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking | 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. |
| Timeliness of Delivering RAIN Exercise | 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. |
| Adherence to Wearing the Smartband | 60 days | Percent of days spent wearing the smartband. |
| Adherence to Answering Smartband Notifications of Smoking Events | 60 days | Percent of smoking notifications answered |
| Adherence to Answering Ecological Momentary Assessment Items | 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. |
| Adherence to Completing Mindfulness Exercises | 60 days | Percent of mindfulness exercises (RAIN, mindful smoking) completed |
| Acceptability of Intervention - Helpfulness of Mindfulness Exercises | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Abstinence From Smoking | 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) |
Countries
United States
Participant flow
Pre-assignment details
155 participants completed onboarding and were considered enrolled and provided demographics data. Of these, 154 participants completed the baseline survey. Of these, 115 participants wore the smartband for at least one day. A modified intent to treat sample was analyzed for outcomes, defined as participants who completed onboarding and wore the smartband for at least one day (N=115).
Participants by arm
| Arm | Count |
|---|---|
| Smokers This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises including RAIN by smartphone app. There is only one arm.
Smartband automatic smoking detection combined with brief mindfulness interventions: Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions | 155 |
| Total | 155 |
Baseline characteristics
| Characteristic | Smokers |
|---|---|
| Age, Customized | 46.06 years STANDARD_DEVIATION 10.41 |
| Education GED/equivalent or high school or less education | 26 Participants |
| Education Some College | 129 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Hispanic White | 3 Participants |
| Race/Ethnicity, Customized Non-hispanic White | 118 Participants |
| Race/Ethnicity, Customized Other or Multiracial | 23 Participants |
| Region of Enrollment United States | 155 participants |
| Sex/Gender, Customized Female | 83 Participants |
| Sex/Gender, Customized Female and Non-binary | 1 Participants |
| Sex/Gender, Customized Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 155 |
| other Total, other adverse events | 0 / 155 |
| serious Total, serious adverse events | 0 / 155 |
Outcome results
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.
Time frame: 60 days
Population: Of the 115, 75 participants completed mindfulness exercises across treatment, 84 participants completed RAIN exercises across treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Smokers | Acceptability of Intervention - Helpfulness of Mindfulness Exercises | Completed at least one mindful smoking exercise and rated it as moderately or more helpful | 74.7 percentage of participants |
| Smokers | Acceptability of Intervention - Helpfulness of Mindfulness Exercises | Completed at least one RAIN exercise and rated it as moderately or more helpful | 76.2 percentage of participants |
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.
Time frame: up to 60 days
Population: N based on number of participants that answered the question at each milestone out of the 115 that wore the smartband for at least one day.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Smokers | Acceptability of Intervention - User Experiences Survey | Instructions for getting started with smartband were easy to follow at onboarding | 110 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | Easy to wear smartband every day at day 21 | 101 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | Helpful to be notified of their smoking events at day 21 | 99 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | Liked being notified of their smoking events at day 21 | 104 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | Being notified of smoking events helped participants pay attention to their smoking at day 21 | 101 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | Mindful smoking exercise were helpful at day 28 | 80 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | Mindful smoking exercise helped them pay attention to their smoking at day 28 | 93 percentage of participants |
| Smokers | Acceptability of Intervention - User Experiences Survey | RAIN exercises were helpful at day 60 | 71 percentage of participants |
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.
Time frame: 60 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Smokers | Adherence to Answering Ecological Momentary Assessment Items | When completed RAIN exercises | 98.3 Percentage of ratings answered |
| Smokers | Adherence to Answering Ecological Momentary Assessment Items | When completed mindful smoking exercises | 100 Percentage of ratings answered |
Primary
Adherence to Answering Smartband Notifications of Smoking Events
Percent of smoking notifications answered
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smokers | Adherence to Answering Smartband Notifications of Smoking Events | 98.2 percentage notifications answered | Standard Deviation 4 |
Primary
Adherence to Completing Mindfulness Exercises
Percent of mindfulness exercises (RAIN, mindful smoking) completed
Time frame: 60 days
Population: Of the 115, 75 participants completed mindfulness exercises across treatment, 94 participants completed RAIN exercises across treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smokers | Adherence to Completing Mindfulness Exercises | mindful smoking exercises | 40.3 percentage of exercises completed | Standard Deviation 31 |
| Smokers | Adherence to Completing Mindfulness Exercises | RAIN exercises | 7.9 percentage of exercises completed | Standard Deviation 13.9 |
Primary
Adherence to Wearing the Smartband
Percent of days spent wearing the smartband.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smokers | Adherence to Wearing the Smartband | 69.6 percentage of days | Standard Deviation 30.5 |
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.
Time frame: 39 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smokers | Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking | percent of mindful smoking exercises correctly triggered | 95.6 percentage of events | Standard Deviation 10.9 |
| Smokers | Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking | percent of false alarms | 9.8 percentage of events | Standard Deviation 17.5 |
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.
Time frame: 60 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smokers | Fidelity of Detecting Smoking Episodes | Average percent of smoking events correctly detected | 90.2 percentage of events | Standard Deviation 17.5 |
| Smokers | Fidelity of Detecting Smoking Episodes | Average percent of false alarms | 9.8 percentage of events | Standard Deviation 17.5 |
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.
Time frame: 30 days
Population: participants who completed at least one RAIN exercise
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Smokers | Timeliness of Delivering RAIN Exercise | Percent participants who rated timeliness as moderate, high or very high | 83.3 percentage of participants |
| Smokers | Timeliness of Delivering RAIN Exercise | Percent participants who rated timeliness as very low or low | 16.7 percentage of participants |
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)
Time frame: 7 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smokers | Number of Participants With Self-reported Abstinence From Smoking | one week point prevalence | 14 Participants |
| Smokers | Number of Participants With Self-reported Abstinence From Smoking | prolonged abstinence | 29 Participants |