Clinical trial NCT04838236: Smoking, Stress, and Mobile Technology
Official title: Improving Access to Cigarette Cessation Treatment Among African American Smokers: Development and Evaluation of an Integrated mHealth Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Tobacco
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2021-04-09
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Week 6 follow-up (Phases II and III)
measure: Levels of satisfaction and perceived treatment quality regarding the intervention, as assessed by the Treatment Quality and Satisfaction Survey
timeFrame: Week 6 follow-up (Phases II and III)
measure: Change in Carbon Monoxide levels at Baseline as measured by the Carbon Monoxide Analysis (Phone Bedfont iCO Smokerlyzer) at follow up appointments.
timeFrame: 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:
measure: Stage of ethnic identity attitudes expressed by participants as measured by the Black Racial Identity Attitude Scale
timeFrame: Baseline
measure: Change from Baseline in depression related impairment on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments.
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
measure: Change from Baseline in anxiety related impairment on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments.
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
measure: Levels of acculturation expressed by participants as measured by the African American Acculturation Scale.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: Change from week 1 follow up in withdrawal symptoms as assessed by the Minnesota Nicotine Withdrawal Scale at subsequent follow up appointments.
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
measure: Change from Screener in levels of anxiety sensitivity on the 5-point Short Scale Anxiety Sensitivity Index at follow up appointments.
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
measure: Change in discrimination burden using the section of the Jackson Heart Study Discrimination Instrument will be used to assess whether our intervention has underlying effects on stress-based burden from racial/ethnic discrimination.
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
measure: Levels of perceived discrimination as measured by the Everyday Discrimination Scale.
timeFrame: Baseline
measure: Time to first lapse
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
measure: Longest time of quit
timeFrame: From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: TSET Health Promotion Research Center
state: Oklahoma
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
state: Texas
Study officials:
References:
citation: 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.