Smoking, Stress, and Mobile Technology

NCT04838236 | Completed DMC

• 1 other identifier: STUDY00000360
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking, Tobacco

Outcome Measures

Primary Outcomes (3)

• A qualitative interview will be used to evaluate the mobile app for style and presentation, perceived utility, ease of use, usefulness of features, and willingness to refer to a friend.

  the Qualitative Interview is a 21-item interview that aims to assess participant experiences with the smartphone applications. This interview will be conducted at the 6-week follow-up phone interview (end-of-treatment) and will be recorded for qualitative data analysis. Patient adherence will be assessed through examination of treatment components that are used within each app (e.g., videos watched, compliance with homework and exposure exercises with a standardized rating scale).

  Week 6 follow-up (Phases II and III)

• Levels of satisfaction and perceived treatment quality regarding the intervention, as assessed by the Treatment Quality and Satisfaction Survey

  The Treatment Quality and Satisfaction Survey was developed for the purposes of this study. This 22-item measure assesses participants' experiences during the treatment period and while using the smart phone application.

  Week 6 follow-up (Phases II and III)

• Change in Carbon Monoxide levels at Baseline as measured by the Carbon Monoxide Analysis (Phone Bedfont iCO Smokerlyzer) at follow up appointments.

  Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \< 7 ppm. This will be used to verify smoking status, as well as change in smoking behaviors throughout the study.

  From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)

Secondary Outcomes (11)

• Stage of ethnic identity attitudes expressed by participants as measured by the Black Racial Identity Attitude Scale

  Baseline

• Change from Baseline in depression related impairment on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments.

  From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)

• Change from Baseline in anxiety related impairment on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments.

  From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)

• Levels of acculturation expressed by participants as measured by the African American Acculturation Scale.

  Baseline

• Items assessing stress levels related to the COVID-19 pandemic will be utilized to explore whether COVID-19 associated stress functions as a moderator of smoking outcomes.

  Baseline

Study Arms (2)

MASP app + NRT

EXPERIMENTAL

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.

Other: MASP app + NRT

QuitGuide app + NRT

OTHER

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

Other: QuitGuide app + NRT

Interventions

MASP app + NRT 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.

MASP app + NRT

QuitGuide app + NRT 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.

QuitGuide app + NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Houston: lead
• University of Oklahoma: collaborator

Study Sites (2)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

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

Houston, Texas, 77204, United States

Location

Related Publications (2)

• 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.

  PMID: 39918847 DERIVED

• 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.

  PMID: 35635746 DERIVED

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 9, 2021
• Study Start: December 20, 2021
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)