key: cord-0716758-06suo1gz authors: Mhende, Josephine; Bell, Sharrill A; Cottrell-Daniels, Cherell; Luong, Jackie; Streiff, Micah; Dannenfelser, Mark; Hayat, Matthew J; Spears, Claire Adams title: Mobile Delivery of Mindfulness-Based Smoking Cessation Treatment Among Low-Income Adults During the COVID-19 Pandemic: Pilot Randomized Controlled Trial date: 2021-07-23 journal: JMIR Form Res DOI: 10.2196/25926 sha: e8edc42fef851ff56230d77777f4972bf11709fb doc_id: 716758 cord_uid: 06suo1gz BACKGROUND: Smoking is the leading cause of premature death, and low-income adults experience disproportionate burden from tobacco. Mindfulness interventions show promise for improving smoking cessation. A text messaging program “iQuit Mindfully” was developed to deliver just-in-time support for quitting smoking among low-income adults. A pilot study of iQuit Mindfully was conducted in spring 2020, during the COVID-19 pandemic, among low-income and predominantly African American smokers. OBJECTIVE: This pilot study examined the acceptability and feasibility of delivering Mindfulness-Based Addiction Treatment via mHealth during the COVID-19 pandemic. METHODS: Participants were adult cigarette smokers (n=23), of whom 8 (34.8%) were female, 19 (82.6%) were African American, and 18 (78.3%) had an annual income of 6 ppm; motivated to quit smoking within 30 days; and at least sixth-grade health literacy (Rapid Estimate of Adult Literacy in Medicine) [32] . Exclusion criteria were as follows: contraindication for nicotine patches, which were provided to them during the study; problematic substance use (Severity of Dependence Scale score >4) [33, 34] or a positive response on at least 2 of the 5 Patient Health Questionnaire Alcohol Abuse/Dependence Scale items [35] ; clinically significant depressive symptoms (a 2-item Patient Health Questionnaire score of >3 [36, 37] ; self-reported diagnosis of schizophrenia or bipolar disorder or the use of antipsychotic medications; and pregnancy or lactation. Individuals currently using tobacco cessation medications and regular (at least weekly) users of tobacco products other than cigarettes were also excluded, although participants were not excluded for the use of e-cigarettes. Individuals did not have to own a mobile phone to participate; they were provided the choice of using their own mobile phone or the one provided to them during the study. This study was approved by the institutional review board of Georgia State University (H19243), and all participants provided written informed consent. This pilot feasibility study was funded by the US National Institutes of Health and is not considered a clinical trial in accordance with the National Institutes of Health's definition [38] . Recruitment involved the distribution of study flyers in the metro-Atlanta area (eg, downtown Atlanta, near train and bus stops, in the local community health centers) and posted on the internet (eg, Craigslist and neighborhood listservs). Although eligibility was not determined on the basis of income, low-income adults were targeted for recruitment in the study. Interested individuals completed an initial telephone screening, followed by in-person screening (expired CO and assessment of health literacy, mental health, and alcohol or drug use). After informed consent was obtained and baseline assessment was carried out, participants were randomized into 1 of 2 treatment groups (in-person MBAT treatment + iQuit Mindfully text messages [n=12] or iQuit Mindfully alone [n=11]). Figure 1 shows the CONSORT (Consolidated Standards of Reporting Trials) flow diagram. Stratified block randomization was implemented with block sizes of 4 and stratification by race and poverty status. Coauthor MJH generated the random allocation sequence, using SAS software system (version 9.4, SAS Institute). A research staff member (blinded to the size of the blocks) assigned participants to interventions with opaque sealed envelopes marked in accordance with the allocation schedule. Apart from members of the research team who were unmasked to handle randomization and delivery of the interventions, other study personnel were blinded to the treatment conditions. Participants completed in-person assessments at baseline. Remote assessments were carried out on the internet at weeks 8 (end of treatment), 9 (follow-up), and 10 (COVID-19 survey) owing to shelter-in-place restrictions. All participants received self-help material, nicotine patch therapy, and the iQuit Mindfully text messaging program. Participants assigned to the MBAT + iQuit Mindfully condition also received MBAT treatment for 8 weeks. All participants were asked to set a quit date between 7 and 30 days from the start of treatment. Participants were recruited to begin the interventions all at once (rather than on a rolling basis), and the 8-week treatment began on February 13, 2020. All participants received the National Cancer Institute's "Clearing the Air" smoking cessation booklet, including the recommendation to call the Tobacco Cessation Quitline (1-800-QUIT-NOW). In accordance with the original MBAT protocol [20] , all participants were provided nicotine patch therapy for 6 weeks, regardless of treatment condition. Patch therapy for participants who smoked more than 10 cigarettes per day consisted of 21-mg patches for 4 weeks, 14-mg patches for 1 week, and 7-mg patches for 1 week. Patch therapy for participants who smoked 5-10 cigarettes per day consisted of 14-mg patches for 4 weeks and 7-mg patches for 2 weeks. Patch dispensation occurred upon in-person assessment visits. Participants were instructed to apply a new patch each day when they woke up, starting on their quit date, and they were provided detailed paper-based and verbal instructions on the proper use of the nicotine patch. At week 8, 11 of 18 (61%) participants with complete data reported having used nicotine patches in the past week (6 of 9 [67%] of those in the MBAT + iQuit Mindfully intervention and 5 of 9 [56%] in the iQuit Mindfully intervention alone). iQuit Mindfully text messages [23, 24] were sent to all participants each day during the 8-week treatment and 1 week of follow-up. The Upland Mobile Messaging platform was used to generate the automated text message system and send and receive text messages. Text messages were based on the MBAT protocol described below and encouraged participants to practice mindfulness (eg, reminders for informal practice, such as awareness of breath throughout the day, and reminders for formal practice such as the body scan and sitting meditation). They also reminded participants to use specific strategies to aid in cessation (eg, removing cues to smoke, reaching out for social support, and trying other coping techniques from the MBAT protocol [20] ). The messages were designed to be interactive; that is, participants were asked questions through a series of flow logic, and they could also text the keywords "CRAVE," "STRESS," "SLIP," or "FACT" at any point to receive an immediate response. Participants could also text keywords (including "MIND," "BODY," and "3MIN") to receive a phone call with a short recording of a mindfulness practice. Messages were personalized on the basis of first names, personal reasons for quitting, and the amount of money to be saved based on individual smoking habits and price paid per pack. Based on feedback from our previous message testing, participants were able to choose the timing and frequency of text messages. Participants chose from several frequency options (ranging from 1-2 to 5-6 per day) as well as a 12-hour time slot of their choice (either 7 AM to 7 PM or 10 AM to 10 PM). Participants were able to change both the frequency and timing at any point throughout the study. Messages were also personalized on the basis of participants' chosen quit dates. Each week they were asked whether they had smoked; if they had smoked and their quit date had passed, participants were encouraged to set a new quit date, which was then updated in the text messaging platform. After the initial set-up on the Upland Mobile Messaging platform, the text message intervention was fully automated. Participants in the MBAT + iQuit Mindfully condition also received 8 weekly 2-hour group sessions, by a certified Mindfulness-Based Stress Reduction instructor and licensed professional counselor. The MBAT protocol closely follows Mindfulness-Based Cognitive Therapy procedures but replaces depression material with information on nicotine dependence and quitting smoking [20] . MBAT emphasizes personal mindfulness practice in several forms, including sitting meditation, body scan meditation, walking meditation, eating meditation, and gentle yoga or stretching. The program teaches present-focused awareness of moment-to-moment experiences and promotes the ability to purposefully respond to thoughts, feelings, and situations rather than automatically reacting by smoking. For example, MBAT enables mindful awareness of stress, craving, and challenging situations so that participants can more skillfully respond to unpleasant sensations. The first 5 weekly sessions were delivered in person. Because of shelter-in-place orders due to COVID-19, sessions 6, 7, and 8 were delivered through the WebEx teleconference platform. The a priori outcomes for this feasibility study were treatment attendance, retention, and participant feedback on the interventions. Because of the onset of the COVID-19 pandemic and our shift to remote intervention and assessment, this study also focuses on participants' experiences specifically in the context of the COVID-19 pandemic. At week 8, participants completed program evaluations to provide their feedback and suggestions for improving the iQuit Mindfully intervention. They were asked the following: "Of all of the text messages that you received as part of this program, how many did you read?" (response options were "None," "Some," "Most," or "All"); "Overall, how helpful were the text messages in getting you to try to quit smoking?" (rated from 1="Not at all helpful" to 10="Extremely helpful"); and "On the scale below, please circle the number that best represents whether you would recommend that other people receive the text messages that you received in this program (or similar texts) as a way to help them quit smoking" (rated from 1="Would not recommend" to 10="Would definitely recommend"). MBAT participants were similarly asked about the extent to which they would recommend the MBAT group sessions to others. At weeks 8 and 9, participants were asked, "In the last 7 days, have you smoked even a puff?" Although biochemical confirmation of smoking behavior had been planned for in-person assessments, this was self-reported owing to web-based or telephone surveys. Missing data were not coded as smoking because of the bias often associated with this "missing=smoking" assumption [39] . At week 10, participants completed a survey of their experiences with stress, smoking, mindfulness practice, and iQuit Mindfully text messages during the COVID-19 pandemic. Participants were asked whether (and how) their level of stress had changed because of the pandemic, with an open-ended follow-up question, "Why do you think your stress level changed?" They were also asked whether their motivation to quit smoking had changed, with a follow-up question of "Why do you think your motivation changed?" Similarly, they were asked about changes in their smoking behavior specifically because of the pandemic, and if so, why. They then answered the following question with a "yes" or "no" response: "Do you think that smoking cigarettes increases a person's chances of getting sick with coronavirus?" The survey also asked whether mindfulness practice was helpful during the pandemic (and if so, how), whether their mindfulness practice had changed since the pandemic, and which mindfulness practices (if any) they had implemented in the past week. Finally, they were asked whether the text messages were helpful during the pandemic (with responses of "yes" or "no"), and, if so, how. Descriptive statistics were used to characterize the study sample as well as indicators of feasibility, acceptability, and experiences during the COVID-19 pandemic. Illustrative participant quotes were selected from open-ended responses on the program evaluations and the COVID-19 survey. As shown in Table 1 , participants were 23 adult cigarette smokers with a mean age of 52 (SD 9.3) years. Slightly over one-third (n=8, 34.8%) were female, and the majority (n=19, 82.6%) were African American. Most (n=18, 78.3%) reported an annual household income of