Mindfulness Takes Practice
Condition: Stress; Habits
Study type: Interventional

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.
    

Intervention name(s): Personalized Anchoring Strategy; Non-Anchoring Strategy Control; Fixed Anchoring Strategy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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).; 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).; 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).
Other intervention name(s): Personalized Cue; Fixed Cue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other