Smoking, Stress, and Mobile Technology

NCT ID: NCT04838236

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2025-04-25

Brief Summary

We seek to refine and evaluate the novel mobile intervention, Mobile Anxiety Sensitivity Program for Smoking (MASP) which was initially developed and previously tested by our team, targeting sensitivity to interoceptive stress, and to apply it among African American smokers. Our culturally adapted intervention is framed within a sociocultural context of interoceptive stress, which is supported by theory, empirical evidence, and characteristics of African American smokers. The MASP app contains educational content on the history of tobacco and the African American community.

Detailed Description

The objective of the current trial is to refine and conduct a comprehensive cultural adaptation of an initially tested novel, mobile intervention that targets anxiety sensitivity (AS) among African American smokers (MASP). The MASP app checks in with users throughout the day to assess their mood, whether or not they're experiencing any cravings or withdrawal symptoms, and their overall mental health. When users indicate they are struggling with staying abstinent, or if they are experiencing heighted levels of stress or anxiety, the app selects and delivers a tailored message from its library of hundreds of messages and videos. For instance, if a user indicates they are struggling with nicotine cravings, and feel as though they are about to smoke, they will receive an individually tailored suggestion on how to cope with the feeling, and strategies to act and overcome it. The app also contains videos that are designed to teach relaxation techniques, as well as training exercises that teach participants how to cope with uncomfortable feelings of stress and nicotine withdrawal they are likely to experience while quitting nicotine. The MASP app has the potential to deliver highly effective and accessible treatment to individuals who are looking to take that major step in their life, and quit smoking for good.

Individuals interested in participating in the study will complete informed consent and a study screener via RedCap and phone call with study staff (signatures will be obtained digitally via RedCap). Those found eligible during the phone screener will download the Insight app onto their personal phone to confirm compatibility and complete the baseline assessment. Those who do not possess a phone that is compatible with the Insight platform will be mailed a compatible phone so they can complete the baseline assessment. Upon completion of the baseline survey, participants will be mailed a Bedfont Carbon Monoxide monitor (iCO) that can be used to remotely verify smoking status, a Greenphire Mastercard, and 4 weeks of NRT. Upon receipt of the iCO, participants will complete a brief phone call to walk them through the use of the iCO and study app. Participants (N=25) in phase II will be in the study for a total of 6 weeks. Upon completion of Phase II, we will analyze data and utilize feedback collected from phase II participants to create MASP 3.0. We will then begin phase III of the study. Participants (N=220) in the study will receive either the MASP 3.0 or QuitGuide plus EMA app following the completion of the baseline assessment. Specifically, following completion on the baseline assessment they will receive a unique code that they will type into the app to place them in the group that they were randomized to. All participants will complete app-based follow-up assessments 1, 2 (quit day), 3, 4, 5, 6, 28, and 54 weeks after the baseline visit. We expect phase III of the study will be completed within a period of 30-36 months.

Conditions

Smoking, Tobacco

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MASP app + NRT

MASP is an intervention designed to assist African American smokers with anxiety sensitivity quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.

Group Type: EXPERIMENTAL

MASP app + NRT

Intervention Type: OTHER

MASP is a mobile intervention that targets anxiety sensitivity among African American smokers (Mobile Anxiety Sensitivity Program for Smoking: MASP). Our intervention is framed within the cultural context of interoceptive stress among African American smokers, which is supported by theory, empirical evidence, and characteristics of this group. The MASP app employs a variety of features to educate its users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. MASP also utilizes Ecological Momentary Assessments (EMAs) to gather information, and provide personalized messages to users in real time.

QuitGuide app + NRT

The QuitGuide app is a standard of care app that allows users to track their nicotine cravings, and provides users with motivational messages.

Group Type: OTHER

QuitGuide app + NRT

Intervention Type: OTHER

Quitguide is a smartphone-based National Cancer Institute (NCI) app for standard mobile smoking cessation treatment. The app contains features that allows its' users to better understand their smoking patters, and build skills needed to becomes and stay smoke free. The app allows users to track their cravings, and delivers motivational messages to users for each craving they track.

Interventions

MASP app + NRT

MASP is a mobile intervention that targets anxiety sensitivity among African American smokers (Mobile Anxiety Sensitivity Program for Smoking: MASP). Our intervention is framed within the cultural context of interoceptive stress among African American smokers, which is supported by theory, empirical evidence, and characteristics of this group. The MASP app employs a variety of features to educate its users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. MASP also utilizes Ecological Momentary Assessments (EMAs) to gather information, and provide personalized messages to users in real time.

Intervention Type: OTHER

QuitGuide app + NRT

Quitguide is a smartphone-based National Cancer Institute (NCI) app for standard mobile smoking cessation treatment. The app contains features that allows its' users to better understand their smoking patters, and build skills needed to becomes and stay smoke free. The app allows users to track their cravings, and delivers motivational messages to users for each craving they track.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

18 years of age or older, self-identify as African American, high anxiety sensitivity defined as a SSASI score of ≥ 5 assessed during phone intake via the SSASI measure (cut-off score to identify high AS individuals), daily smoking (minimum of 5 cigarettes per day) for > 2 years (assessed at pre-screening level [i.e. "Do you currently smoke cigarettes?", "How many cigarettes do you usually smoke on an average day?", "How long have you been smoking at that rate?"] and screening level by providing a picture of their pack of cigarettes, or ashtray in real-time to screen out non-smokers), motivated to quit smoking (≥ 5 on a 10-point scale), willing and able to complete all study surveys/assessments, willing to use NRT, and willing to quit smoking 2 weeks after completion of the baseline survey and receipt of study materials (e.g., iCO, nicotine replacement medications), reside in the United States (assessed at screening level by providing a picture of a valid United States ID card), willing to download and leave the app on the phone for the next year, is able to provide a 12-hour window within a standard day for their wake time, provide their social security number, residency status, and date of birth, Score ≥ 4 on the REALM-SF indicating > 6th grade English literacy level (needed to complete EMAs).

Exclusion Criteria

Report of current or intended participation in a concurrent substance abuse treatment, ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression, not being fluent in English, current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers (via self-report during the phone screen), legal status that will interfere with participation (provided via self-report during the phone screen), cognitive impairment (assessed via the 6-item Cognitive Impairment Test (6CIT)), non-African American, younger than 18, high blood pressure that is not under control, has experienced a heart attack (myocardial infarction) within the past 2 weeks, pregnant or breastfeeding, or planning to become pregnant within the next 6 months. Those who participated in a previous stage of the study will not be eligible to participate in further study stages. Individuals who identify themselves as undocumented immigrants will not be eligible to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Zvolensky, Ph.D.

Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, United States

RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity

Houston, Texas, United States

Countries

United States

References

Cheney MK, Alexander AC, Garey L, Gallagher MW, Hebert ET, Vujanovic AA, Kezbers KM, Matoska CT, Zvolensky MJ, Businelle MS. Adapting a Mobile Health App for Smoking Cessation in Black Adults With Anxiety Through an Analysis of the Mobile Anxiety Sensitivity Program Proof-of-Concept Trial: Qualitative Study. JMIR Form Res. 2025 Feb 7;9:e53566. doi: 10.2196/53566.

Reference Type: DERIVED

PMID: 39918847 (View on PubMed)

Businelle MS, Garey L, Gallagher MW, Hebert ET, Vujanovic A, Alexander A, Kezbers K, Matoska C, Robison J, Montgomery A, Zvolensky MJ. An Integrated mHealth App for Smoking Cessation in Black Smokers With Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 30;11(5):e38905. doi: 10.2196/38905.

Reference Type: DERIVED

PMID: 35635746 (View on PubMed)

Other Identifiers

STUDY00000360

Identifier Type: -

Identifier Source: org_study_id