Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old
Condition: Stress, Physiological; Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      1. Telephone Eligibility Screening

        2. Baseline Visit, includes online questionnaires, physical measures, cognitive tasks,
           voice recordings, physical recordings of brain waves, heart rate, breathing rate, and
           sweat during computer tasks. Collect saliva samples, questionnaire data, and respond to
           handheld device that rings randomly for the seven days following the visit.

        3. Randomized to receive (a) an internet-based Mindfulness Meditation program, (b) an
           internet-based Health & Wellness Education program, or (c) no training. IF assigned to
           receive a training program, participants complete weekly one-hour online trainings and
           daily home practice for 6 weeks

        4. Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline

        5. All participants receive Meditation and Education programs after the Endpoint Visit

        6. Online questionnaire follow-up 6 months after the Endpoint
    

Detailed description: 
      The primary aim of this research project is to evaluate whether an internet-based mindfulness
      meditation training improves cognition and resilience in stressed older adults. Dr. Oken
      specializes in evaluating the effects of stress on the human body, and he plans to use
      advanced statistical analyses to create a "multi-domain physiologic measure." This means
      study staff will collect biological data, including electroencephalogram (EEG, brainwaves),
      blood pressure, heart rate, breathing rate, and saliva samples. The investigator hypothesizes
      that when he statistically combines all of these together, he will have a measure that
      correlates with self-rated (survey) measures of resilience and stress.

      Participants will undergo a telephone screening to determine eligibility, and then they will
      fill out online questionnaires before their Baseline Visit at the lab. Study staff will take
      physical measurements (i.e. height, weight, vision), administer short cognitive tasks that
      measure attention and memory, and collect biological data (listed above) during several
      different tasks. Some of the tasks are very simple, such as breath counting and listening to
      an audio recording of a podcast. And some of the tasks are intended to be more stressful,
      such as one that presents difficult math problems. The investigator hopes to induce stress so
      that study staff can measure resilience by evaluating how long it takes participants to
      return to a biological baseline, such as their usual blood pressure. In total, the visit is
      approximately 3 ½ hours long.

      After the Baseline, participants are sent home with a handheld device that administers random
      5-minute assessments, as well as tubes to collect saliva, for the seven days following the
      in-lab visit. Participants will also fill out short questionnaires about daily events over
      these seven days. Once data collection is complete, participants will come into the lab to
      return the device and samples and learn whether they have been randomized to receive the
      internet-based mindfulness meditation training (40% chance), an internet-based health &
      wellness education program (40% chance), or a non-active waitlist (20% chance). All
      participants will be informed before the study begins that they will have access to the
      meditation and education materials once their participation is complete. Participants
      receiving the meditation and education will complete a one-hour online training each week for
      six weeks, and they will use an iPod to listen to guided meditations or educational podcasts
      (depending on group assignment) for 30-45 minutes per day. The iPod tracks their home
      practice, and they will return it at the end of the study. All participants will receive a
      weekly call from study staff to check in about whether they have experienced any health
      changes and, if applicable, how the meditation or education program is going.

      Eight weeks after the Baseline Visit, participants will again fill out online questionnaires
      and come back to the lab for an Endpoint Visit, which is very similar to the Baseline. They
      will again collect saliva samples and complete assessments on a handheld device for two days
      following the visit. They will mail the samples and device back to the lab and then receive
      access to both internet-based training programs and associated audio recordings. Participants
      will then be asked to fill out online questionnaires one last time 6 months after the
      Endpoint Visit.
    

Intervention name(s): Mindfulness Meditation; Health & Wellness Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Using study-provided iPod device to listen to guided meditations daily; Using study-provided iPod device to listen to educational podcasts daily
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research