Overview
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.
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
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.