StressStresslessNCT02786771
Exploring the Effects of Muse and Spire on Stress Management
A study testing Spire and Muse headband in people with Stress, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Spire and Muse headband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Spire, Muse headband
- Keywords
- Stress Management, Mindfulness, Meditation, Stress Resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpireDevice
Muse headbandDevice
Also called InteraXon
| Study group | Role | What they receive |
|---|---|---|
| Spire device without & with feedback | Experimental | 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. Receives: Device: Spire |
| Muse device & spire device no feedback | Experimental | 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. Receives: Device: Spire; Device: Muse headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786771
- Sponsor's protocol ID
- 2016P000508
- Acronym
- Stressless
- Status last verified
- Aug 2020
- First submitted
- 23 May 2016
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cohen S, Janicki-Deverts D, Miller GE. Psychological stress and disease. JAMA. 2007 Oct 10;298(14):1685-7. doi: 10.1001/jama.298.14.1685. No abstract available.
PubMed 17925521Ellis JG, Gehrman P, Espie CA, Riemann D, Perlis ML. Acute insomnia: current conceptualizations and future directions. Sleep Med Rev. 2012 Feb;16(1):5-14. doi: 10.1016/j.smrv.2011.02.002. Epub 2011 May 18.
PubMed 21596596Kassel JD, Stroud LR, Paronis CA. Smoking, stress, and negative affect: correlation, causation, and context across stages of smoking. Psychol Bull. 2003 Mar;129(2):270-304. doi: 10.1037/0033-2909.129.2.270.
PubMed 12696841Herman JP. Neural pathways of stress integration: relevance to alcohol abuse. Alcohol Res. 2012;34(4):441-7. doi: 10.35946/arcr.v34.4.08.
PubMed 23584110Tully PJ, Baker RA, Turnbull D, Winefield H. The role of depression and anxiety symptoms in hospital readmissions after cardiac surgery. J Behav Med. 2008 Aug;31(4):281-90. doi: 10.1007/s10865-008-9153-8. Epub 2008 Apr 9.
PubMed 18398676Michels N, Sioen I, Braet C, Eiben G, Hebestreit A, Huybrechts I, Vanaelst B, Vyncke K, De Henauw S. Stress, emotional eating behaviour and dietary patterns in children. Appetite. 2012 Dec;59(3):762-9. doi: 10.1016/j.appet.2012.08.010. Epub 2012 Aug 20.
PubMed 22918173Edmondson D, Green P, Ye S, Halazun HJ, Davidson KW. Psychological stress and 30-day all-cause hospital readmission in acute coronary syndrome patients: an observational cohort study. PLoS One. 2014 Mar 12;9(3):e91477. doi: 10.1371/journal.pone.0091477. eCollection 2014.
PubMed 24621575Nerurkar A, Bitton A, Davis RB, Phillips RS, Yeh G. When physicians counsel about stress: results of a national study. JAMA Intern Med. 2013 Jan 14;173(1):76-7. doi: 10.1001/2013.jamainternmed.480. No abstract available.
PubMed 23403892Avey H, Matheny KB, Robbins A, Jacobson TA. Health care providers' training, perceptions, and practices regarding stress and health outcomes. J Natl Med Assoc. 2003 Sep;95(9):833, 836-45.
PubMed 14527051Paulus MP. The breathing conundrum-interoceptive sensitivity and anxiety. Depress Anxiety. 2013 Apr;30(4):315-20. doi: 10.1002/da.22076. Epub 2013 Mar 6.
PubMed 23468141Vlemincx E, Van Diest I, Van den Bergh O. A sigh following sustained attention and mental stress: effects on respiratory variability. Physiol Behav. 2012 Aug 20;107(1):1-6. doi: 10.1016/j.physbeh.2012.05.013. Epub 2012 May 23.
PubMed 22634279Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
PubMed 15256293Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008 Feb;31(1):23-33. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.
PubMed 17899351Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Leon KA, Hyre AD, Ompad D, Desalvo KB, Muntner P. Perceived stress among a workforce 6 months following hurricane Katrina. Soc Psychiatry Psychiatr Epidemiol. 2007 Dec;42(12):1005-11. doi: 10.1007/s00127-007-0260-6. Epub 2007 Oct 11.
PubMed 17932611
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Muse and Spire on Stress Management
- ClinicalTrials.gov ID
- NCT02786771
- Acronym / sponsor ID
- Stressless / 2016P000508
- Conditions
- Stress
- Keywords
- Stress Management, Mindfulness, Meditation, Stress Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 16 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spire device without & with feedback | Experimental | Device: SpireParticipants 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. |
| Muse device & spire device no feedback | Experimental | Device: Spire, Device: Muse headbandParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spire | Device | Muse device & spire device no feedback, Spire device without & with feedback |
| Muse headbandAlso: InteraXon | Device | Muse device & spire device no feedback |
Primary outcome
Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17925521Cohen S, Janicki-Deverts D, Miller GE. Psychological stress and disease. JAMA. 2007 Oct 10;298(14):1685-7. doi: 10.1001/jama.298.14.1685. No abstract available.
- Background: PubMed 21596596Ellis JG, Gehrman P, Espie CA, Riemann D, Perlis ML. Acute insomnia: current conceptualizations and future directions. Sleep Med Rev. 2012 Feb;16(1):5-14. doi: 10.1016/j.smrv.2011.02.002. Epub 2011 May 18.
- Background: PubMed 12696841Kassel JD, Stroud LR, Paronis CA. Smoking, stress, and negative affect: correlation, causation, and context across stages of smoking. Psychol Bull. 2003 Mar;129(2):270-304. doi: 10.1037/0033-2909.129.2.270.
- Background: PubMed 23584110Herman JP. Neural pathways of stress integration: relevance to alcohol abuse. Alcohol Res. 2012;34(4):441-7. doi: 10.35946/arcr.v34.4.08.
- Background: PubMed 18398676Tully PJ, Baker RA, Turnbull D, Winefield H. The role of depression and anxiety symptoms in hospital readmissions after cardiac surgery. J Behav Med. 2008 Aug;31(4):281-90. doi: 10.1007/s10865-008-9153-8. Epub 2008 Apr 9.
- Background: PubMed 22918173Michels N, Sioen I, Braet C, Eiben G, Hebestreit A, Huybrechts I, Vanaelst B, Vyncke K, De Henauw S. Stress, emotional eating behaviour and dietary patterns in children. Appetite. 2012 Dec;59(3):762-9. doi: 10.1016/j.appet.2012.08.010. Epub 2012 Aug 20.
- Background: PubMed 24621575Edmondson D, Green P, Ye S, Halazun HJ, Davidson KW. Psychological stress and 30-day all-cause hospital readmission in acute coronary syndrome patients: an observational cohort study. PLoS One. 2014 Mar 12;9(3):e91477. doi: 10.1371/journal.pone.0091477. eCollection 2014.
- Background: PubMed 23403892Nerurkar A, Bitton A, Davis RB, Phillips RS, Yeh G. When physicians counsel about stress: results of a national study. JAMA Intern Med. 2013 Jan 14;173(1):76-7. doi: 10.1001/2013.jamainternmed.480. No abstract available.
- Background: PubMed 14527051Avey H, Matheny KB, Robbins A, Jacobson TA. Health care providers' training, perceptions, and practices regarding stress and health outcomes. J Natl Med Assoc. 2003 Sep;95(9):833, 836-45.
- Background: PubMed 23468141Paulus MP. The breathing conundrum-interoceptive sensitivity and anxiety. Depress Anxiety. 2013 Apr;30(4):315-20. doi: 10.1002/da.22076. Epub 2013 Mar 6.
- Background: PubMed 22634279Vlemincx E, Van Diest I, Van den Bergh O. A sigh following sustained attention and mental stress: effects on respiratory variability. Physiol Behav. 2012 Aug 20;107(1):1-6. doi: 10.1016/j.physbeh.2012.05.013. Epub 2012 May 23.
- Background: PubMed 15256293Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spire and Muse headband in people with Stress, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout (time frame: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786771, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.