Project MARS: Mobile-Assistance for Regulating Smoking

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking; Current Smoker
• Intervention / Treatment: Behavioral: Messages (participants experiencing negative affect & cigarettes are available); Behavioral: Messages (participants not experiencing negative affect & cigarettes are available); Behavioral: Messages (participants experiencing negative affect & cigarettes are not available); Behavioral: Messages (participants not experiencing negative affect & cigarettes are not available); Behavioral: Moodsurf; Behavioral: Meditate; Behavioral: Joy; Behavioral: Imagine; Behavioral: Notice

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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsey Potter, PhD; Phone Number: 801-213-6036; Email: lindsey.potter@hci.utah.edu
• Study Contact Backup: Name: Cho Lam, PhD; Phone Number: 8012136179; Email: cho.lam@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Recruiting
      • University of Utah
      • Contact: David Wetter, PhD; Phone Number: 801-213-6178
      • Contact: Cho Lam, PhD; Phone Number: 801-213-6179
      • Principal Investigator: David Wetter, PhD
      • Sub-Investigator: Cho Lam, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• Functioning telephone number
• 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
• Current use of tobacco cessation medications or other aids (i.e. buproprion)
• Pregnancy or lactation (as self-reported)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief cognitive/behavioral strategies	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.
Experimental: Effortful self-regulatory activities	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.
No Intervention: No activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically Verified Smoking Abstinence	Smoking abstinence will be completed via self-reported status from participants which are biochemically verified by either expired carbon monoxide via a breathalyzer or a cotinine sample as needed if a participant is unable to attend a visit in-person.	Post-quit date - 6-month follow-up

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Cancer Institute (NCI); University of Michigan
• Investigators: Principal Investigator: David Wetter, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 112287; U01CA229437-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). Before sharing data, data will be stripped of all personal identifiers and all identifying codes. Data will be deemed either sensitive or low-risk, based on our characterization of the possibility of deductive disclosure. Request for sensitive data will be vetted through an assessment of both the requestor's credentials and potential risks. Note that our risk analysis will be based on a joint consideration of the total risk based on all data products requested.
• IPD Sharing Time Frame: The PIs and the research team will work to make the data available in a reasonable amount of time after its collection and following the acceptance for publication of the main findings. Rules for maintaining and distributing data of the University of Utah, the University of Michigan, and the NIH will be followed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No