Garrison 2018.
| Methods |
Study design: RCT Country: USA Recruitment: online via advertisements Study dates: 2014‐2015 |
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| Participants |
Baseline characteristics (n = 325)
Inclusion criteria: age 18–65 years, smoked ≥ 5 cigarettes/day, had ≤ 3 months past‐year abstinence, owned an iPhone/Android, and were motivated to quit, indicated by ≥ 8/10 on the Contemplation Ladder and ≥ 4/5 on an Action item of the Readiness to Change Questionnaire: “I am trying to smoke less than I used to,” 1 = strongly disagree, 5 = strongly agree Exclusion criteria: none specifically stated |
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| Interventions |
Mobile mindfulness training with experience sampling ((MMT‐ES) Craving to quit app): 22 days of training modules (5–15 min/day) teaching mindfulness for SC. The app teaches mindfulness and 3 standard meditation practices: body scan, loving kindness, and breath awareness. Body scan is practiced by bringing awareness to different parts of the body, to foster awareness of body sensations that constitute cravings and affective states. Loving kindness is practiced by directed well‐wishing by repeating phrases such as “may X be happy,” to foster acceptance of oneself and others. Breath awareness is practiced by paying attention to the breath wherever one feels it most strongly in the body, to help retrain the mind away from habitual self‐related thinking toward a more present‐centred awareness. The app also teaches an informal practice to work mindfully with cravings, RAIN: Recognize, Accept, Investigate, and Note what cravings feel like. ES is another feature to measure smoking, craving, and other factors Experience sampling (ES) only (Control app): a smartphone app with the same look and feel as MMT‐ES, delivering only ES for 22 days, to control for potential effects of ES, expectancy effects and nonspecific effects of using a smartphone for SC. |
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| Outcomes | Definition of abstinence: biochemically verified 1‐week point prevalence abstinence at 6 months | |
| Funding source | American Heart Association (14CRP18200010) and the National Institute on Drug Abuse (K12DA00167) | |
| Conflicts of interest | JB and PP own stock in Claritas Mindsciences, the company that developed the apps used in this study. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated (reported in protocol) |
| Allocation concealment (selection bias) | Unclear risk | Detail not stated |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The primary outcome is one‐week point‐prevalence abstinence from tobacco smoking at 6‐months, verified by carbon monoxide monitoring" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Retention among full ITT was 72.6% (MMT‐ES, 78.4%; ES, 74.2%; χ 2 (1) = 1.2, p = .28) and among modified ITT was 83.7% (MMT‐ES, 87.4%; ES, 80.8%; χ 2 (1) = 2.6, p = .11)." Retention 72.6%, no between‐group differences in number of check‐ins or days checked‐in. ITT analysis presented |