Trial Outcomes & Findings for Exploring the Effects of Muse and Spire on Stress Management (NCT NCT02786771)
NCT ID: NCT02786771
Last Updated: 2020-09-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)
Results posted on
2020-09-01
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
|
Overall Study
COMPLETED
|
53
|
56
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploring the Effects of Muse and Spire on Stress Management
Baseline characteristics by cohort
| Measure |
Spire Device Without & With Feedback
n=63 Participants
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
|
Muse Device & Spire Device no Feedback
n=62 Participants
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
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.85 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
37.46 years
STANDARD_DEVIATION 13.51 • n=7 Participants
|
37.15 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
57 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Employment Status
Employed
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment Status
Student
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Employment Status
Retired
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment Status
Unknown
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)Population: Adults over 18 who responded to a online advertisement
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).
Outcome measures
| Measure |
Spire Device Without & With Feedback
n=63 Participants
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
|
Muse Device & Spire Device no Feedback
n=62 Participants
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
|
|---|---|---|
|
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
|
19.15 units on a scale
Standard Deviation 8.92
|
|
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
|
22.49 units on a scale
Standard Deviation 8.63
|
|
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
|
70.00 units on a scale
Standard Deviation 12.39
|
|
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
|
73.44 units on a scale
Standard Deviation 13.34
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=63 participants at risk
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
|
Group 2
n=62 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor Adverse Event
|
1.6%
1/63 • Number of events 1
|
0.00%
0/62
|
Additional Information
Odeta Dyrmishi - Acting Project Manager
Partners Connected Health Innovation
Phone: 6177243605
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place