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Randomized Controlled Trial
. 2022 Sep 12;24(9):e35620.
doi: 10.2196/35620.

Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial

Louisa G Sylvia #  1   2 , Mitchell R Lunn  3 , Juno Obedin-Maliver  3 , Robert N McBurney  4 , W Benjamin Nowell  5 , Rachel L Nosheny  6 , Richard A Mularski  7 , Millie D Long  8 , Peter A Merkel  9 , Mark J Pletcher  6 , Roberta E Tovey  1 , Christopher Scalchunes  10 , Rebecca Sutphen  11 , Ann S Martin  12 , Elizabeth J Horn  13 , Megan O'Boyle  13 , Lisa Pitch  14 , Michael Seid  15 , Susan Redline  16 , Sophie Greenebaum  1 , Nevita George  1 , Noah J French  1 , Caylin M Faria  1 , Nicha Puvanich  1 , Dustin J Rabideau  17 , Caitlin A Selvaggi  17 , Chu Yu  17 , Stephen V Faraone  18 , Shilpa Venkatachalam  5 , Debbe McCall  19 , Sharon F Terry  20 , Thilo Deckersbach  1 , Andrew A Nierenberg  1   2
Affiliations
Randomized Controlled Trial

Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial

Louisa G Sylvia et al. J Med Internet Res. .

Abstract

Background: Mindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is unknown how much mindfulness practice and training are necessary to improve well-being.

Objective: The primary aim of this study was to determine whether a standard 8-session web-based mindfulness-based cognitive therapy (MBCT) program, compared with a brief 3-session mindfulness intervention, improved overall participant well-being. In addition, we sought to explore whether the treatment effects differed based on the baseline characteristics of the participants (ie, moderators).

Methods: Participants were recruited from 17 patient-powered research networks, web-based communities of stakeholders interested in a common research area. Participants were randomized to either a standard 8-session MBCT or a brief 3-session mindfulness training intervention accessed on the web. The participants were followed for 12 weeks. The primary outcome of the study was well-being, as measured by the World Health Organization-Five Well-Being Index. We hypothesized that MBCT would be superior to a brief mindfulness training.

Results: We randomized 4411 participants, 3873 (87.80%) of whom were White and 3547 (80.41%) of female sex assigned at birth. The mean baseline World Health Organization-Five Well-Being Index score was 50.3 (SD 20.7). The average self-reported well-being in each group increased over the intervention period (baseline to 8 weeks; model-based slope for the MBCT group: 0.78, 95% CI 0.63-0.93, and brief mindfulness group: 0.76, 95% CI 0.60-0.91) as well as the full study period (ie, intervention plus follow-up; baseline to 20 weeks; model-based slope for MBCT group: 0.41, 95% CI 0.34-0.48; and brief mindfulness group: 0.33, 95% CI 0.26-0.40). Changes in self-reported well-being were not significantly different between MBCT and brief mindfulness during the intervention period (model-based difference in slopes: -0.02, 95% CI -0.24 to 0.19; P=.80) or during the intervention period plus 12-week follow-up (-0.08, 95% CI -0.18 to 0.02; P=.10). During the intervention period, younger participants (P=.05) and participants who completed a higher percentage of intervention sessions (P=.005) experienced greater improvements in well-being across both interventions, with effects that were stronger for participants in the MBCT condition. Attrition was high (ie, 2142/4411, 48.56%), which is an important limitation of this study.

Conclusions: Standard MBCT improved well-being but was not superior to a brief mindfulness intervention. This finding suggests that shorter mindfulness programs could yield important benefits across the general population of individuals with various medical conditions. Younger people and participants who completed more intervention sessions reported greater improvements in well-being, an effect that was more pronounced for participants in the MBCT condition. This finding suggests that standard MBCT may be a better choice for younger people as well as treatment-adherent individuals.

Trial registration: ClinicalTrials.gov NCT03844321; https://clinicaltrials.gov/ct2/show/NCT03844321.

Keywords: clinical trial; cognitive therapy; control trial; eHealth; intervention; mental health; mindful; mindfulness; mobile phone; web; well-being.

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Conflict of interest statement

Conflicts of Interest: LGS receives grant funding from National Institutes of Health and Patient Centered Outcomes Research Institute as well as royalties from New Harbinger. She has also served on the Scientific Advisory Boards for Depression and Bipolar Support Alliance and the Milken Institute. AAN received funding as a consultant and scientific advisory board member for headspace health. In accordance with the Patient-Centered Research Outcomes Institute policy and federal law, portions of this manuscript will be published on Patient-Centered Research Outcomes Institute’s website as a final research report. In the past year, SVF has either received income, potential income, travel expenses, continuing education support, research support or several of these aids from Aardvark, Akili, Genomind, Ironshore, KemPharm/Corium, Noven, Ondosis, Otsuka, Rhodes, Supernus, Takeda, Tris, and Vallon. With his institution, he has US patent US20130217707 A1 for the use of sodium-hydrogen exchange inhibitors in the treatment of Attention Deficit Hyperactivity Disorder. In previous years, he received support from Alcobra, Arbor, Aveksham, CogCubed, Eli Lilly, Enzymotec, Impact, Janssen, Lundbeck/Takeda, McNeil, NeuroLifeSciences, Neurovance, Novartis, Pfizer, Shire, and Sunovion. He also receives royalties from books published by Guilford Press: "Straight Talk about Your Child’s Mental Health"; Oxford University Press: "Schizophrenia: The Facts"; and Elsevier: "ADHD: Non-Pharmacologic Interventions". In addition, he is the program director of Attention Deficit Hyperactivity Disorder in Adults.

Figures

Figure 1
Figure 1
Enrollment flow diagram. An intervention session was marked as complete only if the participant had completed the entire session. Participants were not allowed to skip any page during the intervention sessions. MBCT: mindfulness-based cognitive therapy; WHO-5: World Health Organization—Five Well-Being Index.
Figure 2
Figure 2
Well-being by week by intervention group. The total WHO-5 score can range from 0 to 100, although we restricted the y-axis to the 25% and 75% quantiles (40 and 72, respectively) of the WHO-5 scores reported in this study. Points correspond to sample means and vertical lines correspond to pointwise 95% CIs for the means. MBCT: mindfulness-based cognitive therapy; WHO-5: World Health Organization—Five Well-Being Index.
See this image and copyright information in PMC

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