Project MARS: Mobile-Assistance for Regulating Smoking

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Tobacco Smoking; Current Smoker

Treatments: Behavioral: Joy; Behavioral: Messages (participants experiencing negative affect & cigarettes are not available); Behavioral: Messages (participants experiencing negative affect & cigarettes are available); Behavioral: Messages (participants not experiencing negative affect & cigarettes are available); Behavioral: Notice; Behavioral: Meditate; Behavioral: Messages (participants not experiencing negative affect & cigarettes are not available); Behavioral: Imagine; Behavioral: Moodsurf

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04376489

112287

U01CA229437-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

112 participants in 3 patient groups

Brief cognitive/behavioral strategies

Experimental group

Treatment:

Behavioral: Messages (participants experiencing negative affect & cigarettes are not available)

Behavioral: Messages (participants not experiencing negative affect & cigarettes are available)

Behavioral: Messages (participants experiencing negative affect & cigarettes are available)

Behavioral: Messages (participants not experiencing negative affect & cigarettes are not available)

Effortful self-regulatory activities

Experimental group

Treatment:

Behavioral: Notice

Behavioral: Meditate

Behavioral: Moodsurf

Behavioral: Joy

Behavioral: Imagine

No activities

No Intervention group