Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout

Study Overview
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Brief Summary
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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 or older, above average stress level (PSS score >21), 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.

Official Title
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Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial

Conditions
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Stress, Burnout

Intervention / Treatment
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* Behavioral: reviga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 18 living in Germany employed (minimum of 20h/week) increased stress level (>21 on the PSS-10) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reviga + TAU<br>Participants allocated to the intervention group will receive access to reviga in addition to treatment as usual (TAU). reviga is a digital health application designed for individuals with stress and burnout, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by reviga are relaxation, psychoeducation and exercises regarding relevant cognitions and behavior, acceptance, relationships, problem solving strategies, and positive psychology. The program operates through interactive dialogues, which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days. | Behavioral: reviga<br>* Participants will receive access to the digital health intervention reviga in addition to TAU.<br>|
| No Intervention: TAU<br>Participants allocated to the control group will receive access to treatment as usual (TAU). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress symptoms | Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome). | 3 months, 6 months | 
| Functioning | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome). | 3 months, 6 months | 
| Burnout symptoms | Oldenburg Burnout Inventory (OLBI). Two subscales (exhaustion and disengagement), each ranging from 8-32; higher scores mean higher burnout symptoms (worse outcome). | 3 months, 6 months | 
| Health-related quality of life | Assessment of Quality of Life - 8D (AQoL-8D). AQoL-8D score ranging from 0-100; higher scores mean higher quality of life (better outcome). | 3 months, 6 months | 
| Sick days | Number of sick days in the past 3 months | 3 months, 6 months | 
| Stress symptoms | Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome). | 6 months |