Exploring the Effects of Muse and Spire on Stress Management

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.

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Key information

Conditions

Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spire

Device

Muse headband

Device

Other names: InteraXon

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: Stressless

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jun 1, 2016
Registry last updated: Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed