Exploring the Effects of Muse and Spire on Stress Management

NCT02786771 | Completed Results

• 1 other identifier: 2016P000508
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress

Keywords

Stress Management; Mindfulness; Meditation; Stress Resilience

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

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.

Device: Spire; Device: Muse headband

Interventions

Spire DEVICE

Muse device & spire device no feedback; Spire device without & with feedback

Muse headband DEVICE

Also known as: InteraXon

Muse device & spire device no feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (17)

• 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.

  PMID: 17925521 BACKGROUND

• 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.

  PMID: 21596596 BACKGROUND

• 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. doi: 10.1037/0033-2909.129.2.270.

  PMID: 12696841 BACKGROUND

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

  PMID: 23584110 BACKGROUND

• 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.

  PMID: 18398676 BACKGROUND

• 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.

  PMID: 22918173 BACKGROUND

• 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.

  PMID: 24621575 BACKGROUND

• 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. No abstract available.

  PMID: 23403892 BACKGROUND

• 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.

  PMID: 14527051 BACKGROUND

• 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.

  PMID: 23468141 BACKGROUND

• 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.

  PMID: 22634279 BACKGROUND

• 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. doi: 10.1016/S0022-3999(03)00573-7.

  PMID: 15256293 BACKGROUND

• 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. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.

  PMID: 17899351 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• 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. doi: 10.1007/s00127-007-0260-6. Epub 2007 Oct 11.

  PMID: 17932611 BACKGROUND

• 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. doi: 10.1016/s0895-4356(98)00109-7.

  PMID: 9817135 BACKGROUND

• Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

  PMID: 12964174 BACKGROUND

Related Links

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

Results Point of Contact

• Title: Odeta Dyrmishi - Acting Project Manager
• Organization: Partners Connected Health Innovation

odyrmishi@partners.org

6177243605

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 1, 2020
• Results First Posted: May 16, 2018

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share