Stress
Conditions
Keywords
Stress Management, Mindfulness, Meditation, Stress Resilience
Brief summary
The goal of this study is to evaluate the effectiveness of Spire and Muse on stress management. The study will be implemented as a 2-arm randomized controlled pilot study to assess the effect of either device on stress management from the end of baseline to closeout.
Detailed description
Both Muse and Spire are recent technologies that could improve our understanding of stress management and enhance quality of healthcare. The goal of this study is to evaluate if Spire and Muse help individuals self-manage stress. Spire has been designed as a discrete clip-on tracker that monitors changes in respiration rate. With the companion app, this device displays breathing rates in real time and alerts the user through push notification in times of tension. Studies show that controlled breathing reduces stress. On the other hand, Muse is a headset device that uses EEG (electroencephalogram) sensors that measures electric brain frequencies. Muse guides the user in a form of simplified meditation by giving feedback in real time (i.e. calm, neutral, active) and audio clues to improve concentration. Previous studies have shown that engaging in meditation has the potential to reduce anxiety and stress.
Interventions
DEVICESpire
DEVICEMuse headband
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Registered for Partners HealthCare Connected Health Symposium 2016 * Over 18 years old * Able to read and speak English * Own a smartphone and have internet connection * Willing to wear a Spire device during all hours (except sleep) * Willing to use the Muse device (Group 2 ONLY) * Willing to participate in a research study and sign the consent form
Exclusion criteria
* Not Registered for Partners HealthCare Connected Health Symposium 2016 * Under 18 years old * Not able to read and speak English * Do not own a smartphone and have internet connection * Not willing to wear a Spire device during all hours (except sleep) * Not willing to use the Muse device (Group 2 ONLY) * Not willing to sign the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | total of 8 weeks (2 weeks of baseline + 6 weeks of intervention) | The change of perceived stress and stress resilience within and between Group 1 and 2 from enrollment to closeout. The change of perceived stress is measured by the Perceived Stress Scale-14 (a validated psychological instrument of 14 items), each each rated on a 5 point scale(0-4) for measuring the respondent's perception of stress in the past month.The PSS-14 ranges from 0 to a high score of 56, with a higher score indicating more stress (worse outcome). The change of stress resilience is measured by the Connor-Davidson Stress Resilience Scale (25 items). It evaluates different aspects of stress coping ability that seeks to understand how well respondents would be able to buffer adverse conditions and cope with stress, each rated on a 5 point scale (0-4). The CD-RISC ranges from 0 to 100, with a higher score representing better stress resilience (a better outcome). |
Participant flow
Pre-assignment details
In reference to comment \[2\] we had 126 participants that were enrolled in the study but only 125 that started the study. One participant that signed the consent form did not pass the eligibility criteria and therefore was not randomized into a study group and did not start the study.
Participants by arm
| Arm | Count |
|---|---|
| Spire Device Without & With Feedback Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.
Spire | 63 |
| Muse Device & Spire Device no Feedback Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.
Spire
Muse headband | 62 |
| Total | 125 |
Baseline characteristics
| Characteristic | Muse Device & Spire Device no Feedback | Spire Device Without & With Feedback | Total |
|---|---|---|---|
| Age, Continuous | 37.46 years STANDARD_DEVIATION 13.51 | 36.85 years STANDARD_DEVIATION 11.72 | 37.15 years STANDARD_DEVIATION 12.6 |
| Employment Status Employed | 52 Participants | 51 Participants | 103 Participants |
| Employment Status Retired | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Student | 7 Participants | 7 Participants | 14 Participants |
| Employment Status Unemployed | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Unknown | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 52 Participants | 49 Participants | 101 Participants |
| Region of Enrollment Australia | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Canada | 3 participants | 0 participants | 3 participants |
| Region of Enrollment Spain | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United Kingdom | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 57 participants | 61 participants | 118 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 40 Participants | 41 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 62 |
| other Total, other adverse events | 1 / 63 | 0 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 62 |
Outcome results
Primary
Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout
The change of perceived stress and stress resilience within and between Group 1 and 2 from enrollment to closeout. The change of perceived stress is measured by the Perceived Stress Scale-14 (a validated psychological instrument of 14 items), each each rated on a 5 point scale(0-4) for measuring the respondent's perception of stress in the past month.The PSS-14 ranges from 0 to a high score of 56, with a higher score indicating more stress (worse outcome). The change of stress resilience is measured by the Connor-Davidson Stress Resilience Scale (25 items). It evaluates different aspects of stress coping ability that seeks to understand how well respondents would be able to buffer adverse conditions and cope with stress, each rated on a 5 point scale (0-4). The CD-RISC ranges from 0 to 100, with a higher score representing better stress resilience (a better outcome).
Time frame: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)
Population: Adults over 18 who responded to a online advertisement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spire Device Without & With Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Perceived Stress Scale at Enrollment | 23.59 units on a scale | Standard Deviation 8.83 |
| Spire Device Without & With Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Stress Resilience at Closeout | 69.5 units on a scale | Standard Deviation 14.6 |
| Spire Device Without & With Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Stress Resilience at Enrollment | 68.25 units on a scale | Standard Deviation 14.57 |
| Spire Device Without & With Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Perceived Stress Scale at Closeout | 20.24 units on a scale | Standard Deviation 7.89 |
| Muse Device & Spire Device no Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Perceived Stress Scale at Enrollment | 22.49 units on a scale | Standard Deviation 8.63 |
| Muse Device & Spire Device no Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Perceived Stress Scale at Closeout | 19.15 units on a scale | Standard Deviation 8.92 |
| Muse Device & Spire Device no Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Stress Resilience at Enrollment | 70.00 units on a scale | Standard Deviation 12.39 |
| Muse Device & Spire Device no Feedback | Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | Stress Resilience at Closeout | 73.44 units on a scale | Standard Deviation 13.34 |