Project MARS: Mobile-Assistance for Regulating Smoking

NCT ID: NCT04376489

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2023-01-31

Brief Summary

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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

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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

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Current Smoker Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Micro-Randomized Trial (MRT) in the development of data-driven behavioral interventions.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Brief cognitive/behavioral strategies

Group Type EXPERIMENTAL

Messages (participants experiencing negative affect & cigarettes are available)

Intervention Type BEHAVIORAL

Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.

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

Intervention Type BEHAVIORAL

Participants receive messages tailored for situations when they cigarettes are available.

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

Intervention Type BEHAVIORAL

Participants receive messages tailored for situations when they experiencing negative affect.

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

Intervention Type BEHAVIORAL

Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.

Effortful self-regulatory activities

Group Type EXPERIMENTAL

Moodsurf

Intervention Type BEHAVIORAL

Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.

Meditate

Intervention Type BEHAVIORAL

Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.

Joy

Intervention Type BEHAVIORAL

Smart phone app that teaches participants to practice breathing exercise.

Imagine

Intervention Type BEHAVIORAL

Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.

Notice

Intervention Type BEHAVIORAL

Smart phone app that teaches participants to accept their thoughts and feelings.

No activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Messages (participants experiencing negative affect & cigarettes are available)

Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.

Intervention Type BEHAVIORAL

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

Participants receive messages tailored for situations when they cigarettes are available.

Intervention Type BEHAVIORAL

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

Participants receive messages tailored for situations when they experiencing negative affect.

Intervention Type 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.

Intervention Type BEHAVIORAL

Moodsurf

Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.

Intervention Type BEHAVIORAL

Meditate

Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.

Intervention Type BEHAVIORAL

Joy

Smart phone app that teaches participants to practice breathing exercise.

Intervention Type BEHAVIORAL

Imagine

Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.

Intervention Type BEHAVIORAL

Notice

Smart phone app that teaches participants to accept their thoughts and feelings.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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David Wetter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Wetter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Inbal Nahum-Shani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lindsey Potter, PhD

Role: CONTACT

801-213-6036

Cho Lam, PhD

Role: CONTACT

8012136179

Facility Contacts

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David Wetter, PhD

Role: primary

801-213-6178

Cho Lam, PhD

Role: backup

801-213-6179

Other Identifiers

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U01CA229437-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

112287

Identifier Type: -

Identifier Source: org_study_id

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