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Stressless: Exploring the Effects of Muse and Spire on Stress Management

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02786771
Collaborator
(none)
126
Enrollment
2
Arms
4
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spire
  • Device: Muse headband
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Exploring the Effects of Muse and Spire on Stress Management
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: Spire
Experimental: 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.

Device: Spire

Device: Muse headband
Other Names:
  • InteraXon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT02786771
    Other Study ID Numbers:
    • 2016P000508
    First Posted:
    Jun 1, 2016
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
    Stress Management
    Mindfulness
    Meditation
    Stress Resilience

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 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.
    Arm/Group Title Spire Device Without & With Feedback Muse Device & Spire Device no Feedback
    Arm/Group Description 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 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
    Period Title: Overall Study
    STARTED 63 62
    COMPLETED 53 56
    NOT COMPLETED 10 6

    Baseline Characteristics

    Arm/Group Title Spire Device Without & With Feedback Muse Device & Spire Device no Feedback Total
    Arm/Group Description 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 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 of all reporting groups
    Overall Participants 63 62 125
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    36.85
    (11.72)
    37.46
    (13.51)
    37.15
    (12.6)
    Sex: Female, Male (Count of Participants)
    Female
    22
    34.9%
    22
    35.5%
    44
    35.2%
    Male
    41
    65.1%
    40
    64.5%
    81
    64.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    7
    11.1%
    5
    8.1%
    12
    9.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    4
    6.3%
    3
    4.8%
    7
    5.6%
    White
    49
    77.8%
    52
    83.9%
    101
    80.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    3
    4.8%
    2
    3.2%
    5
    4%
    Region of Enrollment (participants) [Number]
    United States
    61
    96.8%
    57
    91.9%
    118
    94.4%
    Spain
    1
    1.6%
    0
    0%
    1
    0.8%
    Australia
    1
    1.6%
    1
    1.6%
    2
    1.6%
    Canada
    0
    0%
    3
    4.8%
    3
    2.4%
    United Kingdom
    0
    0%
    1
    1.6%
    1
    0.8%
    Employment Status (Count of Participants)
    Employed
    51
    81%
    52
    83.9%
    103
    82.4%
    Unemployed
    1
    1.6%
    0
    0%
    1
    0.8%
    Student
    7
    11.1%
    7
    11.3%
    14
    11.2%
    Retired
    0
    0%
    1
    1.6%
    1
    0.8%
    Unknown
    4
    6.3%
    2
    3.2%
    6
    4.8%

    Outcome Measures

    1. Primary Outcome
    Title Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Adults over 18 who responded to a online advertisement
    Arm/Group Title Spire Device Without & With Feedback Muse Device & Spire Device no Feedback
    Arm/Group Description 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 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
    Measure Participants 63 62
    Perceived Stress Scale at Closeout
    20.24
    (7.89)
    19.15
    (8.92)
    Perceived Stress Scale at Enrollment
    23.59
    (8.83)
    22.49
    (8.63)
    Stress Resilience at Enrollment
    68.25
    (14.57)
    70.00
    (12.39)
    Stress Resilience at Closeout
    69.5
    (14.6)
    73.44
    (13.34)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Group 1 Group 2
    Arm/Group Description 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 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
    All Cause Mortality
    Group 1 Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/63 (0%) 0/62 (0%)
    Serious Adverse Events
    Group 1 Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/63 (0%) 0/62 (0%)
    Other (Not Including Serious) Adverse Events
    Group 1 Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/63 (1.6%) 0/62 (0%)
    Skin and subcutaneous tissue disorders
    Minor Adverse Event 1/63 (1.6%) 1 0/62 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Odeta Dyrmishi - Acting Project Manager
    Organization Partners Connected Health Innovation
    Phone 6177243605
    Email odyrmishi@partners.org
    Responsible Party:
    Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT02786771
    Other Study ID Numbers:
    • 2016P000508
    First Posted:
    Jun 1, 2016
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020