This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
114
Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.
Participants receive messages tailored for situations when they are not experiencing negative affect \& cigarettes are available.
University of Utah
Salt Lake City, Utah, United States
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment
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.
Time frame: 1 hour following micro-randomization
Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment.
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.
Time frame: 1 hour following micro-randomization
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Participants receive messages tailored for situations when they are experiencing negative affect \& cigarettes are not available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
Smart phone app that teaches participants to practice breathing exercise.
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
Smart phone app that teaches participants to accept their thoughts and feelings.
Proximal Cigarette Use
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.
Time frame: approximately 1 hour following the decision point
Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use
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.
Time frame: approximately 1 hour following the decision point
Proximal Tobacco Product Use (PTPU) Use
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.
Time frame: approximately 1 hour following the decision point