NCT04376489

Project MARS: Mobile-Assistance for Regulating Smoking

Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to identify states of vulnerability for lapse, identify states of receptivity for engaging in self-regulatory activities, and investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.

Detailed description

Aim 1: Identify states of vulnerability for lapse: Self-reported and sensor-based measures will be used to identify empirically-based and theoretically-grounded features across multiple time scales that are most predictive of lapse. Operationalizing vulnerability in terms of the predicted level of risk for lapse, the investigators hypothesize that (H1) current vulnerability is represented by current and/or recent high negative emotions, low positive emotions, high craving, low self-efficacy, low self-regulatory capacity (SRC), and risky context (e.g., specific locations, such as a bar; cigarettes available; others smoking). Aim 2: Identify states of receptivity for engaging in self-regulatory activities: Self-reported and sensor-based measures will be used to identify empirically-based and theoretically-grounded features across multiple time scales that are most predictive of engagement (i.e., usage of self-regulatory activities). Operationalizing receptivity in terms of the predicted likelihood of engagement, the investigators hypothesize that (H2) current receptivity is represented by high positive activating emotions (e.g., happy, grateful), low negative deactivating emotions (e.g., sad, boredom), low craving, high self-efficacy, high SRC, and low risk contexts (e.g., specific locations, such as home). Aim 3: 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 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) are administered before and after JITAIs with items that are designed to measure different indices that may be related to participants' engagement of the JITAIs.

Conditions

• Current Smoker
• Tobacco Smoking

Interventions

Type	Name	Description
BEHAVIORAL	Messages (participants experiencing negative affect & cigarettes are available)	Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.
BEHAVIORAL	Messages (participants not experiencing negative affect & cigarettes are available)	Participants receive messages tailored for situations when they cigarettes are available.
BEHAVIORAL	Messages (participants experiencing negative affect & cigarettes are not available)	Participants receive messages tailored for situations when they experiencing negative affect.
BEHAVIORAL	Messages (participants not experiencing negative affect & cigarettes are not available)	Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
BEHAVIORAL	Moodsurf	Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
BEHAVIORAL	Meditate	Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
BEHAVIORAL	Joy	Smart phone app that teaches participants to practice breathing exercise.
BEHAVIORAL	Imagine	Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
BEHAVIORAL	Notice	Smart phone app that teaches participants to accept their thoughts and feelings.

Timeline

• Start date: 2020-08-27
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2020-05-06
• Last updated: 2022-10-26

Locations

1 site across 1 country: United States