Current Smoker, Tobacco Smoking
Conditions
Brief summary
This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.
Detailed description
Investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts. Investigate whether, what type, and under what conditions (e.g., current state of vulnerability and/or receptivity) a prompt to engage the individual in self-regulatory activities via mobile app increases engagement, hence reduces vulnerability. The proposed research will help build a comprehensive conceptual, technical, and empirical foundation necessary to develop effective Just-in-Time-Adaptive-Interventions (JITAIs) based on dynamic models of vulnerability and receptivity. In the micro-randomized trial (MRT), Ecological momentary assessments (EMAs) assessed proximal engagement with self-regulatory strategies, substance use, and other contextual factors after each micro-randomization.
Interventions
BEHAVIORALMessages recommending low effort strategies (participants experiencing negative affect & cigarettes are available)
Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.
BEHAVIORALMessages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available)
Participants receive messages tailored for situations when they are not experiencing negative affect \& cigarettes are available.
BEHAVIORALMessages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available)
Participants receive messages tailored for situations when they are experiencing negative affect \& cigarettes are not available.
BEHAVIORALMessages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available)
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
BEHAVIORALMessages recommending low effort strategies (when participants did not complete the 2-question survey)
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
BEHAVIORALMore effortful activity: Moodsurf
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
BEHAVIORALMore effortful activity: Meditate
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
BEHAVIORALMore effortful activity: Joy
Smart phone app that teaches participants to practice breathing exercise.
BEHAVIORALMore effortful activity: Imagine
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
BEHAVIORALMore effortful activity: Notice
Smart phone app that teaches participants to accept their thoughts and feelings.
Sponsors
University of Utah
University of Michigan
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Micro-Randomized Trial (MRT) in the development of data-driven behavioral interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Current smoker with an average of at least 3 cigarettes/day * Motivated to quit within the next 30 days * Valid home address in Utah, Nevada, and Arizona * Functioning telephone number and access to reliable wifi * Can speak, read, and write in English * At least marginal health literacy (as determined by 45 or greater on REALM literacy test)
Exclusion criteria
* Contraindication for nicotine patch or gum * Current use of tobacco cessation medications or other aids (i.e. buproprion) * Pregnancy or lactation (as self-reported)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment | 1 hour following micro-randomization | Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were: 1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No); 2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No); 3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No). Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant. |
| Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment. | 1 hour following micro-randomization | Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were: 1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No); 2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No); 3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No). Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal Cigarette Use | approximately 1 hour following the decision point | Proximal Cigarette Use (PCU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal Cigarette Use was created, coded as 1 if the response included "Cigarettes" and 0 otherwise. This outcome measure reports the proportion that reported PCU at 1 hour following micro-randomization. The intent of this Outcome Measures is to report overall PCU use according to participant's self-reported engagement with self-regulatory strategies. |
| Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use | approximately 1 hour following the decision point | Proximal Nicotine-Containing Non-Cessation Product Use (NCNCP) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal NCNCP Use was created, coded as 1 if the response included "Cigarettes", "Vape pen, JUUL, or e-cigarette," "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise. This outcome measure will report the proportion that reported NCNCP Use at 1 hour following micro-randomization. |
| Proximal Tobacco Product Use (PTPU) Use | approximately 1 hour following the decision point | Proximal Nicotine-Containing Non-Cessation Product Use (PTPU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of PTPU was created, coded as 1 if the response included "Cigarettes", "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise. This outcome measure will report the proportion that reported PTPU at 1 hour following micro-randomization. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Wetter, PhD
University of Utah
PRINCIPAL_INVESTIGATORInbal Nahum-Shani, PhD
University of Michigan
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Income $100,000 and greater: | 10 Participants |
| Income $10,000 - $19,999: | 13 Participants |
| Income $20,000 - $29,999: | 17 Participants |
| Income $30,000 - $39,999: | 8 Participants |
| Income $40,000 - $49,999: | 10 Participants |
| Income $50,000 - $59,999: | 9 Participants |
| Income $60,000 - $69,999: | 8 Participants |
| Income $70,000 - $79,999: | 5 Participants |
| Income $80,000 - $89,999: | 3 Participants |
| Income $90,000 - $99,999: | 3 Participants |
| Income Did not disclose: | 10 Participants |
| Income Less than or equal to $9,999: | 15 Participants |
| Partner Status Did not disclose | 4 Participants |
| Partner Status Does Not Have Partner | 60 Participants |
| Partner Status Has Partner | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Region of Enrollment United States | 111 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 40 Participants |
| Tobacco History | 13.7 number of cigarettes smoked per day STANDARD_DEVIATION 7.97 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 114 |
| other Total, other adverse events | 2 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
None listed