Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Project MARS: Mobile-Assistance for Regulating Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04376489
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
University of Michigan
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Wetter, University of Utah

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.

Condition or disease Intervention/treatment Phase
Current Smoker Tobacco Smoking 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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Micro-Randomized Trial (MRT) in the development of data-driven behavioral interventions.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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



Primary Outcome Measures :
  1. Biochemically Verified Smoking Abstinence [ Time Frame: Post-quit date - 6-month follow-up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376489


Contacts
Layout table for location contacts
Contact: Rebecca Stoffel 8012136184 rebecca.stoffel@hci.utah.edu
Contact: Cho Lam, PhD 8012136179 cho.lam@hci.utah.edu

Sponsors and Collaborators
University of Utah
University of Michigan
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: David Wetter, PhD University of Utah
Principal Investigator: Inbal Nahum-Shani, PhD University of Michigan
Layout table for additonal information
Responsible Party: David Wetter, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04376489    
Other Study ID Numbers: 112287
U01CA229437-01 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No