Status:
COMPLETED
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
Lead Sponsor:
Gaia AG
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Hannover Medical School
Conditions:
Stress
Burnout
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress leve...
Eligibility Criteria
Inclusion
- age 18-65 years
- living in Germany
- employed (minimum of 20h/week)
- ICD-10 diagnosis Z73, operationalized as above average general stress level (PSS score \> 21) and increased levels of work-related stress / burnout (OLBI score ≥ 2.18)
- stable treatment (psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion
- consent to participation
Exclusion
- plans to change treatment (psychotherapy, medication, ...) in the upcoming three months at the time of inclusion
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2024
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT05998161
Start Date
September 4 2023
End Date
June 22 2024
Last Update
April 4 2025
Active Locations (1)
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1
GAIA AG
Hamburg, Germany, 22085