Mindfulness Takes Practice

NCT04378530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2022-07-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Personalized Anchoring Strategy

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).

BEHAVIORAL

Non-Anchoring Strategy Control

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).

BEHAVIORAL

Fixed Anchoring Strategy

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).

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Principal Investigators

  • Chad Stecher, PhD · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378530 on ClinicalTrials.gov