NCT04838236

Smoking, Stress, and Mobile Technology

Improving Access to Cigarette Cessation Treatment Among African American Smokers: Development and Evaluation of an Integrated mHealth Application

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: University of Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2021-12-20
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2021-04-09
• Last updated: 2025-05-16

Locations

2 sites across 1 country: United States