Clinical trial NCT04376489: Project MARS: Mobile-Assistance for Regulating Smoking
Official title: Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Current Smoker
Tobacco Smoking
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Cancer Institute (NCI)
First posted: 2020-05-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Micro-Randomized Trial (MRT) in the development of data-driven behavioral interventions.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Biochemically Verified Smoking Abstinence
timeFrame: Post-quit date - 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: David Wetter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Inbal Nahum-Shani, PhD
role: PRINCIPAL_INVESTIGATOR
References: