Quality of Life, Sleep, Stress, Emotional
Conditions
Keywords
mindfulness, Wellness
Brief summary
A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.
Detailed description
Participants will be instructed on how to use a brain sensing device and corresponding digital application to engage in structured digital mindfulness practices daily for 3 months. Subjects will be requested to use the device and practice daily, but the amount of time and frequency daily will be to their choosing. Subjects will also complete questionnaires and cognitive based testing throughout participation.
Interventions
DEVICEMuse S™ Headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
Sponsors
InteraXon, Inc.
Cambridge Brain Sciences
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older at time of consent * Practicing Physicians at Mayo Clinic * Not pregnant by subject self-report at time of consent * Have the ability to provide informed consent * Have the ability to complete all aspects of this trial * Have access to a smart phone or tablet device * Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators
Exclusion criteria
* Used an investigational drug within the past 30 days * Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis * Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress * An unstable medical or mental health condition as determined by the physician investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency Adherence to Intervention | 3 months | Summarizing frequency subjects use intervention during active study participation (during 3 month study period) |
| Duration Adherence to Intervention | 3 months | Summarizing duration of time subjects use intervention during active study participation (during 3 month time period) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) Score Difference | 90 days | The Perceived Stress Scale (PSS) is a 10-item 5-point Likert scale that measures global life stress by assessing the degree (Never, almost never, sometimes, often and very often) to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The score difference is the average change from Day 90 to Baseline. |
| Resilience Score Difference | 90 days | Resilience was measured using the Connor-Davison Resilience Scale 10 (CD-RS10). This is a 10-item, 5-point likert scale, validated, scoring system. Scores can range from 0 to 40, with higher scores indicating higher resilience. The CD-RS10 is a reliable means of assessing resilience and most often used in medical and/or disaster studies. Difference from Day 90 to baseline for the resilience score |
| LASA Score Difference | 90 days | Quality of Life was measured using the validated Linear Analogue Self-Assessment (LASA) scale. This measure is a 6-item, 11-point likert scale, validated scoring system that measure of quality of life (QOL), in which QOL is conceptualized as a multidimensional construct with five domains (physical, functional, emotional, spiritual, and social). In this measure, each domain can score 0 as the worst possible and 10 being the best possible. The total score for QoL could range from 0 to 60 with higher score indicating greater QoL. Change from Day 90 to Baseline for the LASA score |
Countries
United States
Participant flow
Recruitment details
Participants who were patients in the long COVID-19 clinic were invited to participate if they were found to be eligible for the study.
Participants by arm
| Arm | Count |
|---|---|
| Muse-S Group Participants used Muse-S for the study period (up to 3 months). | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Muse-S Group |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| LASA baseline score | 39.2 units on a scale STANDARD_DEVIATION 6.59 |
| Perceived Stress Scale baseline score | 11.1 units on a scale STANDARD_DEVIATION 3.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Resilience baseline score | 27.4 units on a scale STANDARD_DEVIATION 5.01 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Duration Adherence to Intervention
Summarizing duration of time subjects use intervention during active study participation (during 3 month time period)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse-S Group | Duration Adherence to Intervention | 5.9 minutes | Standard Deviation 1.9 |
Primary
Frequency Adherence to Intervention
Summarizing frequency subjects use intervention during active study participation (during 3 month study period)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse-S Group | Frequency Adherence to Intervention | 57.8 times used | Standard Deviation 30.6 |
Secondary
LASA Score Difference
Quality of Life was measured using the validated Linear Analogue Self-Assessment (LASA) scale. This measure is a 6-item, 11-point likert scale, validated scoring system that measure of quality of life (QOL), in which QOL is conceptualized as a multidimensional construct with five domains (physical, functional, emotional, spiritual, and social). In this measure, each domain can score 0 as the worst possible and 10 being the best possible. The total score for QoL could range from 0 to 60 with higher score indicating greater QoL. Change from Day 90 to Baseline for the LASA score
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse-S Group | LASA Score Difference | 2.7 units on a scale | Standard Deviation 6 |
Secondary
Perceived Stress Scale (PSS) Score Difference
The Perceived Stress Scale (PSS) is a 10-item 5-point Likert scale that measures global life stress by assessing the degree (Never, almost never, sometimes, often and very often) to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The score difference is the average change from Day 90 to Baseline.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse-S Group | Perceived Stress Scale (PSS) Score Difference | -2.1 units on a scale | Standard Deviation 3.81 |
Secondary
Resilience Score Difference
Resilience was measured using the Connor-Davison Resilience Scale 10 (CD-RS10). This is a 10-item, 5-point likert scale, validated, scoring system. Scores can range from 0 to 40, with higher scores indicating higher resilience. The CD-RS10 is a reliable means of assessing resilience and most often used in medical and/or disaster studies. Difference from Day 90 to baseline for the resilience score
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse-S Group | Resilience Score Difference | 1.4 units on a scale | Standard Deviation 3.9 |