Exploring the Effects of Muse and Spire on Stress Management (Stressless)
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|ClinicalTrials.gov Identifier: NCT02786771|
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : May 16, 2018
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress||Device: Spire Device: Muse headband||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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: Muse headband
Other Name: InteraXon
- 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).