StressLAVENDERNCT05998161
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
A study testing reviga in people with Stress and Burnout, run by Gaia AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- reviga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteGermany
- Study dates
- 4 Sep 2023to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- plans to change treatment (psychotherapy, medication, ...) in the upcoming three months at the time of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial
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.
- Being tested
- reviga
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revigaBehavioural
Participants will receive access to the digital health intervention reviga in addition to TAU.
| Study group | Role | What they receive |
|---|---|---|
| reviga + TAU | Experimental | 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. Receives: Behavioral: reviga |
| TAU | No intervention | Participants allocated to the control group will receive access to treatment as usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress symptoms
Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
Measured: 3 months
Secondary outcomes (6)
Anxiety symptoms
Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).
Measured: 3 months, 6 months
Functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Measured: 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).
Measured: 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).
Measured: 3 months, 6 months
Sick days
Number of sick days in the past 3 months
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start4 Sep 2023
- Primary completion22 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Kamila Jauch-Chara, MD, Principal investigator, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998161
- Sponsor's protocol ID
- reviga RCT 2023
- Acronym
- LAVENDER
- Status last verified
- Apr 2025
- First submitted
- 9 Aug 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05998161
- Acronym / sponsor ID
- LAVENDER / reviga RCT 2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, Hannover Medical School
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reviga + TAU | Experimental | Behavioral: revigaParticipants 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. |
| TAU | No intervention | –Participants allocated to the control group will receive access to treatment as usual (TAU). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- plans to change treatment (psychotherapy, medication, ...) in the upcoming three months at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| revigaParticipants will receive access to the digital health intervention reviga in addition to TAU. | Behavioural | reviga + TAU |
Primary outcome
Stress symptoms
Time frame: 3 months
Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
6 secondary outcomes
Anxiety symptoms
Time frame: 3 months, 6 months
Functioning
Time frame: 3 months, 6 months
Burnout symptoms
Time frame: 3 months, 6 months
Health-related quality of life
Time frame: 3 months, 6 months
Sick days
Time frame: 3 months, 6 months
Stress symptoms
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Jauch-Chara, MD principal investigator
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reviga in people with Stress and Burnout, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.