Exploring the Effects of Muse and Spire on Stress Management

Stress Clinical Trial

— Stressless  

Official title:

Exploring the Effects of Muse and Spire on Stress Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786771
• Other study ID #: 2016P000508
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Device:
• Spire

• Muse headband

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

References & Publications (17)

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. — View Citation

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)

External Links

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