Mindfulness Takes Practice

NCT04378530 | Completed

• 1 other identifier: STUDY00011788
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Conditions

Stress; Habits

Outcome Measures

Primary Outcomes (1)

• Persistence of daily meditation

  Persistence of daily meditation will be measured using objective app usage data provided by the Calm app informatics. Data will be on daily meditation minutes and an indicator for any daily meditation. We will measure change in persistence in daily meditation throughout the study.

  Change measured over study (8 weeks) and follow up (16 weeks) periods.

Secondary Outcomes (9)

• Stress

  Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)

• Anxiety

  Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)

• Depression

  Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)

• Global Health

  Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)

• PTSD

  Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)

Study Arms (3)

Personalized Cue

EXPERIMENTAL

Participants in the intervention group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Participants will be asked to select a cue to use to remember to meditate.

Behavioral: Personalized Anchoring Strategy

Study control

ACTIVE COMPARATOR

Participants in the control group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive non-anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day.

Behavioral: Non-Anchoring Strategy Control

Fixed Cue

EXPERIMENTAL

Participants in the intervention group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Participants will be given a specific cue (i.e. leaving the bathroom in the morning) to use to remember to meditate.

Behavioral: Fixed Anchoring Strategy

Interventions

Personalized Anchoring Strategy BEHAVIORAL

The study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific 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. Participants will be asked to choose a cue to use as an anchoring strategy. Health and well-being measures will be taken at baseline and post-intervention. 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 1x per day (8am, 1pm or 6pm).

Also known as: Personalized Cue

Personalized Cue

Non-Anchoring Strategy Control BEHAVIORAL

The study will run for 8 weeks. Control participants will participate in the meditation features in their Calm account. Each participant will receive non-anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The control group will not be provided an anchoring strategy video on the persistence of daily meditation practice and receive non-anchoring strategy specific push notification study reminders. Health and well-being measures will be taken at baseline and post-intervention. 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 1x per day (8am, 1pm or 6pm).

Study control

Fixed Anchoring Strategy BEHAVIORAL

The study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific 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. Participants will be asked to use a cue given by the research team. Health and well-being measures will be taken at baseline and post-intervention. 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 1x per day (8am, 1pm or 6pm).

Also known as: Fixed Cue

Fixed Cue

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• 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.

  PMID: 34941558 DERIVED

MeSH Terms

Conditions

Habits

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chad Stecher, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: May 7, 2020
• Study Start: July 27, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)