Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2022-10-31
2023-06-30
Brief Summary
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The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion.
Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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cerena™
Subjects who took part in the cerena™ group during the original RESTORE study
Long-term follow-up of cerena™
Long term follow-up for eligible participants from the RESTORE study
attune™
Subjects who took part in the attune™ group during the original RESTORE study
Long-term follow-up of attune™
Long term follow-up for eligible participants from the RESTORE study
Interventions
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Long-term follow-up of cerena™
Long term follow-up for eligible participants from the RESTORE study
Long-term follow-up of attune™
Long term follow-up for eligible participants from the RESTORE study
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Blue Note Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Dianne M Shumay, PhD
Role: PRINCIPAL_INVESTIGATOR
Blue Note Therapeutics
Locations
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Blue Note Therapeutics
San Francisco, California, United States
Countries
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Other Identifiers
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PROT005
Identifier Type: -
Identifier Source: org_study_id