Exploring the Effects of Muse and Spire on Stress Management (Stressless)

• ClinicalTrials.gov Identifier: NCT02786771
• Recruitment Status: Completed
• First Posted: June 1, 2016
• Results First Posted: May 16, 2018
• Last Update Posted: September 1, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Joseph C. Kvedar, Massachusetts General Hospital

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
Stress	Device: Spire; Device: Muse headband	Not Applicable

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 (Clinical Trial)
• 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: July 2016
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 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 Name: InteraXon

Outcome Measures

Primary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

No Contacts or Locations Provided

More Information

Additional Information:

12. Morajevi, N, "You can't force calm: designing and evaluating respiratory regulating interfaces for calming technology" 

Publications:

Cohen S, Janicki-Deverts D, Miller GE. Psychological stress and disease. JAMA. 2007 Oct 10;298(14):1685-7.

Ellis 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. Review.

Kassel 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. Review.

Herman JP. Neural pathways of stress integration: relevance to alcohol abuse. Alcohol Res. 2012;34(4):441-7. Review.

Tully 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.

Michels 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.

Edmondson 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.

Nerurkar 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.

Avey 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.

Paulus 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. Review.

Vlemincx 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.

Grossman 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.

Carmody 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. Epub 2007 Sep 25.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96.

Leon 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. Epub 2007 Oct 11.

Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8.

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82.

• Responsible Party: Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02786771
• Other Study ID Numbers: 2016P000508
• First Posted: June 1, 2016
• Results First Posted: May 16, 2018
• Last Update Posted: September 1, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Joseph C. Kvedar, Massachusetts General Hospital:

Stress Management; Mindfulness; Meditation; Stress Resilience