A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults
Condition: Meditation; Control Group
Study type: Interventional

Summary: 
      The purpose of this study is to determine the preliminary effects of using a mobile app
      (i.e., Calm) to decrease overall stress in middle-aged (i.e., 40-64 years) men and women who
      report high stress (greater than 15 on PSS).

      The study design is a randomized control trial with baseline, post-intervention (4 weeks from
      baseline), and follow-up phone interview (5 weeks from baseline) assessments. Middle-aged
      adults will be randomized to either a Calm meditation Intervention group or an attention
      control podcast group. Participants will be randomized after the completion of baseline and
      informed consent.

      Specific aim 1: Determine the feasibility (acceptability, demand) of using CALM app at least
      10 min/day to reduce stress (greater than 15 on Perceived Stress Scale [PSS]) in middle-aged
      men and women.

      Benchmarks for feasibility: (acceptability) Recruitment greater than 40 percent men; greater
      than 75 percent satisfied with intervention; 75 percent perceive daily meditation and app
      components as appropriate and useful; (demand) Retention of men greater than 75 percent;
      greater than 80 percent adherence (minutes/week) to the meditation intervention.

      Specific aim 2: Explore the preliminary effect of meditation using Calm on overall perceived
      stress as compared to the health education group.

      Specific aim 3: Explore the preliminary effect of meditation using Calm on anxiety and
      depression.

      Specific aim 4: Explore gender as a moderator of the effect of meditation using Calm on
      stress.

      Specific aim 5: Explore the mediators of mindfulness, physical activity, eating, and coping
      behaviors on stress, anxiety and depression using Calm for meditation.
    

Detailed description: 
      Recruitment: Participants will be recruited during winter/spring 2020. Interested
      participants will be directed to a REDCap link to complete an online eligibility screener.
      The screener will take approximately 10 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; participants will be sent an informed consent
      and baseline questionnaire via a REDCap link. This measure should take approximately 25
      minutes to complete (See Informed Consent and Baseline Questionnaires). Once Informed Consent
      is signed and the Baseline Questionnaires are complete, participants will be randomized via
      an online randomizer (i.e., randomizer.com) to either an attention control podcast group or
      the Calm meditation group. Ineligible participants will be sent an email notifying their
      status and why.

      Enrollment: The Research Team will email the intervention participants that will include
      instructions to download Calm (See Participant Scripts). The control participants will be
      emailed instructions to download the podcast app (See Participant Scripts).

      Intervention: The intervention will run for 4-weeks. Intervention participants will complete
      the 30 day, "How to Meditate" meditation series that provides daily 10-minute meditations and
      the control group will listen to daily 10-minute health education podcasts. Throughout the
      intervention, both groups will be sent reminder emails via REDCap to participate in their
      assigned practice sessions (see Participant Scripts) participants will complete online weekly
      participation logs via REDCap. Additionally, they will answer one, multiple choice EMA
      (ecological momentary assessment) question, randomly, 3x per day (between 8am and 8pm) via
      test message assessing how one currently feels (see Study Questionnaires).

      Tracking: Participation in the Calm meditations will be tracked (meditation name, time of
      day, and time spent in meditation) by weekly REDCap participation logs and the Calm team.

      Post-intervention: Post-intervention questionnaires and the satisfaction survey will be
      emailed to intervention and control participants via a link from REDCap (See
      Post-intervention questionnaires). The post-intervention survey will take about 25 minutes
      and the satisfaction survey will take about 10 minutes.

      Post-intervention interview: Post-intervention phone interviews will be conducted the week
      following the end of the intervention (week 5) to no more than 20 participants in each group
      and take about 15-20 minutes.
    

Intervention name(s): Calm Meditation; Educational Podcast Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will run for 4-weeks. Participants will complete the 30 day, "How to Meditate" meditation series that provides daily 10-minute meditations. Throughout the intervention, participants will be sent reminder emails via REDCap to participate in their assigned practice sessions participants and will complete online weekly participation logs via REDCap. Additionally, they will answer one, multiple-choice ecological momentary assessment question, randomly, 3x per day via test message assessing how one currently feels. Participants will complete baseline and post-intervention measures of the Perceived Stress Scale, Hospital Anxiety and Depression Scale, Mindfulness Attention Awareness Scale, International Physical Activity Questionnaire, Salzberg Stress Eating Scale, Brief Cope, and Brief Resilience Scale. Following these measures, participants will be asked to complete a satisfaction questionnaire (week 5) and have the opportunity to volunteer for a short phone interview.; The intervention will run for 4-weeks. Control group participants will listen to daily 10-minute health education podcasts. Throughout the intervention, participants will be sent reminder emails via REDCap to participate in their assigned practice sessions and participants will complete online weekly participation logs via REDCap. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question, randomly, 3x per day via test message assessing how one currently feels. Participants will complete baseline and post-intervention measures of the Perceived Stress Scale, Hospital Anxiety and Depression Scale, Mindfulness Attention Awareness Scale, International Physical Activity Questionnaire, Salzberg Stress Eating Scale, Brief Cope, and Brief Resilience Scale. Following these measures, participants will be asked to complete a satisfaction questionnaire (week 5) and have the opportunity to volunteer for a short phone interview.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other