Mindfulness Takes Practice

Stress Clinical Trial

Official title:

Mindfulness Takes Practice: mHealth Tools for Building Persistent Mindfulness Meditation Habits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378530
• Other study ID #: STUDY00011788
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Habits
• Stress

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Arizona Biomedical Collaborative	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stress	Stress will be measured using the Perceived Stress Scale -10 item, with scores ranging from 10-40) and a higher score indicates a worse outcome.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	Anxiety	Anxiety will be measured using the Hospital Anxiety and Depression Scale, with scores ranging from 0-21, and a higher score indicates a worse outcome.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	Depression	Depression will be measured using the Hospital Anxiety and Depression Scale, with scores ranging from 0-21, and a higher score indicates a worse outcome.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	Global Health	Global health will be measured using the PROMIS Global Health Scale v1.2, with scores ranging from 4-20, and higher scores indicate a better outcome.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	PTSD	PTSD will be measured using the Impact of Events Scale-Revised, with scores ranging from 0-88, with higher scores indicating a worse outcome.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	Emotional Regulation	Emotional regulation will be measured using the Difficulties in Emotional Regulation -18, with scores ranging from 18-90, with higher scores indicating a worse outcome.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	HABIT	Habit will be measured using the habit questionnaire scored is the sum across the four questions (which are individually scored from 1-5 based on degree of agreement), where a higher score indicates more behavioral automaticity (strong habit).	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	COVID-19	COVID-19 as a mediator to the other health and well-being measures will be measured through a COVID-19 questionnaire created by the researcher. The items are scored from 1-5 with higher scores indicating COVID as a more significant mediator.	Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Secondary	Feasibility: Acceptability	Acceptability will be measured using a satisfaction survey at the end of the study, following all other measures (satisfied with the intervention and perceive daily meditation and app components as appropriate and useful)	Measured at post-intervention about experience in study (8 weeks) and follow up (16 weeks)