Burnout, Stress
Conditions
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.
Interventions
BEHAVIORALreviga
Participants will receive access to the digital health intervention reviga in addition to TAU.
Sponsors
University Hospital Schleswig-Holstein
Hannover Medical School
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
All endpoints are patient-reported outcome measures (PROMs). Given that participants are aware of their study group (receiving reviga in addition to treatment as usual or only receiving treatment as usual), this trial is not blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress symptoms | 3 months | Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress symptoms | 6 months | Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome). |
| Anxiety symptoms | 3 months, 6 months | Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome). |
| Functioning | 3 months, 6 months | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome). |
| Burnout symptoms | 3 months, 6 months | Oldenburg Burnout Inventory (OLBI). Two subscales (exhaustion and disengagement), each ranging from 8-32; higher scores mean higher burnout symptoms (worse outcome). |
| Health-related quality of life | 3 months, 6 months | Assessment of Quality of Life - 8D (AQoL-8D). AQoL-8D score ranging from 0-100; higher scores mean higher quality of life (better outcome). |
| Sick days | 3 months, 6 months | Number of sick days in the past 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| hospital stays | 3 months, 6 months | Number of hospital stays in the past 3 months |
| curative stays | 3 months, 6 months | Number of curative stays in the past 3 months |
| doctor visits | 3 months, 6 months | Number of doctor visits in the past 3 months |
| Effort and reward imbalance | 3 months, 6 months | Effort-reward-imbalance (ERI). Three subscales: effort, ranging from 3-12, higher scores mean higher effort; reward, ranging from 7=28, higher scores mean higher reward; over-commitment, ranging from 6-24, higher scores mean higher over-commitment. Ratio effort/reward: scores \>1 mean more efforts for each reward (worse outcome). |
| Depressive symptoms | 3 months, 6 months | Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome). |
Countries
Germany
Outcome results
None listed