Clinical trial NCT05998161: Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
Official title: Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Burnout
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
name: Hannover Medical School
First posted: 2023-08-18
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* plans to change treatment (psychotherapy, medication, ...) in the upcoming three months at the time of inclusion

Primary outcomes:
measure: Stress symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: 3 months, 6 months
measure: Functioning
timeFrame: 3 months, 6 months
measure: Burnout symptoms
timeFrame: 3 months, 6 months
measure: Health-related quality of life
timeFrame: 3 months, 6 months
measure: Sick days
timeFrame: 3 months, 6 months
measure: Stress symptoms
timeFrame: 6 months
Other outcomes:
measure: Depressive symptoms
timeFrame: 3 months, 6 months
measure: Effort and reward imbalance
timeFrame: 3 months, 6 months
measure: hospital stays
timeFrame: 3 months, 6 months
measure: curative stays
timeFrame: 3 months, 6 months
measure: doctor visits
timeFrame: 3 months, 6 months
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel
name: Kamila Jauch-Chara, MD
role: PRINCIPAL_INVESTIGATOR
References: