Mindfulness Meditation for Cognition and Mood: A Pilot Study Evaluating Feasibility and Collecting Preliminary Data
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Primary Endpoint
- Recruitment
Study Overview
Brief Summary
The purpose of this pilot study is to collect feasibility and acceptability of an internet mindfulness meditation intervention for older adults and to collect preliminary data on mood and cognition changes from before to after the intervention. Up to 32 older adults will be randomized to receive a mindfulness meditation intervention or a time and attention control, both delivered over the internet (16 completers). Participants will have a one-hour session weekly for six weeks with daily home practice between sessions. Participants will complete the sessions online with a study iPad. Their home practice will also be installed on the study iPad as well as an objective adherence monitoring program that the investigators developed to track actual home practice between sessions. The feasibility and acceptability measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood questionnaires and cognitive tasks will be measured before and after the intervention period and data used to conduct power analyses and sample size estimation for a larger clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 65 - 90 years old
- •Baseline Perceived Stress Scale1 score ≥ 9
- •Stable on medications six weeks prior to and during study
- •Willing to learn and use study technology
- •Can hear and understand instructions
- •Willing to accept randomization scheme and agrees to follow the study protocol
Exclusion Criteria
- •Cognitive impairment limiting ability to give consent or follow the protocol (≤26 on the mTICS)2
- •Significant acute medical illness that would decrease likelihood of study completion (self-report).
- •Significant, untreated depression, as assessed by CESD-5 >16 during screening.
- •Current daily meditation practice (≥5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)
Outcomes
Primary Outcomes
Recruitment
Time Frame: Week 8
Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study.
Participant satisfaction
Time Frame: Week 8
Client Satisfaction Questionnaire
Secondary Outcomes
- Mood(Week 0, Week 8)
- Cognition(Week 0, Week 8)
Investigators
Helane Wahbeh
Assistant Professor
Oregon Health and Science University