Clinical trial NCT04378530: Mindfulness Takes Practice
Official title: Mindfulness Takes Practice: mHealth Tools for Building Persistent Mindfulness Meditation Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Habits
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to optimize the delivery of mHealth tools to support the formation of persistent mindfulness meditation routines.

Aim 1: Identify the efficacy of the anchoring strategy on the persistence of daily meditation practice.

H1: Persistence (measured through repeated observations of panel regression models of the daily likelihood of mindfulness mediation over the 16-week follow-up period) will be greater among AG as compared to CG.

Aim 2: Determine participant phenotypes that are (a) associated with successfully anchoring daily meditation or (b) likely to need additional supports. Potential moderators of the anchoring strategy's success include participants' daily schedule, type of work, household composition, motivation, time and risk preferences, and prior exposure to mindfulness, which will be analyzed in the panel regression model framework above.

Aim 3: Determine the optimal type, timing, and sequence of push notifications for encouraging daily mindfulness meditation within and across study groups. The efficacy of each push notification type (tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders), timing, and dynamics on the anchoring of daily meditation will inform a subsequent, just-in-time adaptive intervention (JITAI).

Impact: This study will inform an optimal JITAI R01 proposal that will personalize the type and temporal dynamics of app-based daily supports for successfully routinizing daily meditation, and determine its effects on mental health, specifically PTSD. Lifetime prevalence of PTSD is 7% in adults and meditation is known to reduce PTSD. If effective

Detailed description: Recruitment: Participants will be recruited for a "health and well-being" study starting July, 2020. Interested participants will be directed to a Qualtrics link to complete an online eligibility screener. The screener will take approximately 3 minutes to complete (See Eligibility Survey). The survey will be free, voluntary, and available online. Participants will be allowed to skip questions in the survey.

Eligibility: Once eligibility is determined, eligible participants will be sent an informed consent. Ineligible participants will be sent an email notifying their status and why. Once an informed consent is signed and received, the participant will be notified of their random assignment and study start date. Participants will be randomized via an online randomizer (i.e., randomizer.com) to either the Anchor Group (intervention) or the control group.

Enrollment: The Research Team will email the participants instructions to download Calm (See Participant Scripts). On their study start date the participant will be sent their baseline questionnaires via a Qualtrics link. The measures will be online and should take approximately 20 minutes to complete (See Baseline Questionnaires).

Intervention: The study will run for 8-weeks. Intervention participants will receive access to the mobile application Calm and be recommended to participate in the meditation features. Each participant will receive push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. The control group will receive access to the mobile application Calm and be recommended to participate in the meditation features but will not be asked to watch the anchoring strategy video. The control group will also receive push notification reminders however, they will not be anchor strategy specific (See Push Notifications).

Tracking: Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question each evening (see Study Questionnaires).

Post-study: Post-study questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from Qualtrics (See Post-study questionnaires). The post-intervention surveys will be online and take about 20 minutes and the satisfaction survey will take about 5 minutes.

Follow up: Participants will receive a follow up survey to complete via Qualtrics at 16 weeks. Follow up questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from Qualtrics. The follow up surveys will be online and take about 20 minutes and the satisfaction survey will take about 5 minutes. The follow up surveys will be identical to the post-study questionnaires.

Eligibility criteria: Inclusion Criteria:

* Men or Women
* Between 18 and 60 years of age
* Able to read/understand English
* Have access to a smartphone on a daily basis
* Reside in the US or a US territory
* Willing to be randomized
* Willing to download a mobile application
* Paid for Calm but do not use it OR paid for 60 days and then after 30 days no activity

Exclusion Criteria:

* Currently using the Calm app or another meditation app
* Currently participating in \>60 mins of meditation/yoga in one month within the last 6 months.
* Currently reside outside the United States
* Email provided is not associated with Calm account

Primary outcomes:
measure: Persistence of daily meditation
timeFrame: Change measured over study (8 weeks) and follow up (16 weeks) periods.
Secondary outcomes:
measure: Stress
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: Anxiety
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: Depression
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: Global Health
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: PTSD
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: Emotional Regulation
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: HABIT
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: COVID-19
timeFrame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
measure: Feasibility: Acceptability
timeFrame: Measured at post-intervention about experience in study (8 weeks) and follow up (16 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
affiliation: Arizona State University
name: Chad Stecher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stecher C, Sullivan M, Huberty J. Using Personalized Anchors to Establish Routine Meditation Practice With a Mobile App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 22;9(12):e32794. doi: 10.2196/32794.