Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT05998161
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2023-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
Sponsor:
Gaia AG
Organization:
Study Overview
Official Title:
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAVENDER
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 level, the unguided online intervention reviga.
Inclusion criteria are: age 18-65 years, 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), living in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days at the time of inclusion, and consent to participation. Exclusion criterion is having plans to change the treatment in the upcoming three months at the time of inclusion.
Patients will be randomized and allocated to either an intervention group, receiving reviga in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control group will be granted access to the program at the end of the study. Primary endpoint will be the perceived stress measured by the PSS score, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick days.
Inclusion criteria are: age 18-65 years, 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), living in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days at the time of inclusion, and consent to participation. Exclusion criterion is having plans to change the treatment in the upcoming three months at the time of inclusion.
Patients will be randomized and allocated to either an intervention group, receiving reviga in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control group will be granted access to the program at the end of the study. Primary endpoint will be the perceived stress measured by the PSS score, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: