Project MARS: Mobile-Assistance for Regulating Smoking

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376489
• Other study ID #: 112287
• Secondary ID: U01CA229437-01
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: January 2023

Study information

• Verified date: October 2022
• Source: University of Utah
• Contact: Lindsey Potter, PhD
• Phone: 801-213-6036
• Email: lindsey.potter[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Current Smoker
• Tobacco Smoking

Intervention

Behavioral:
• Messages (participants experiencing negative affect & cigarettes are available)
Participants receive messages tailored for situations when they experiencing negative affect & cigarettes are available.
• Messages (participants not experiencing negative affect & cigarettes are available)
Participants receive messages tailored for situations when they cigarettes are available.
• Messages (participants experiencing negative affect & cigarettes are not available)
Participants receive messages tailored for situations when they experiencing negative affect.
• 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.
• Moodsurf
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
• Meditate
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
• Joy
Smart phone app that teaches participants to practice breathing exercise.
• Imagine
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
• Notice
Smart phone app that teaches participants to accept their thoughts and feelings.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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