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Completed

NCT Number: NCT05998161

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

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Burnout Burnout, Psychological Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reviga

Behavioral

Participants will receive access to the digital health intervention reviga in addition to TAU.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Anxiety symptoms

    Time frame: 3 months, 6 months

    Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).

  2. Functioning

    Time frame: 3 months, 6 months

    Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).

  3. Burnout symptoms

    Time frame: 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).

  4. Health-related quality of life

    Time frame: 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).

  5. Sick days

    Time frame: 3 months, 6 months

    Number of sick days in the past 3 months

  6. Stress symptoms

    Time frame: 6 months

    Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).

Other outcomes

  1. Depressive symptoms

    Time frame: 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).

  2. Effort and reward imbalance

    Time frame: 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).

  3. hospital stays

    Time frame: 3 months, 6 months

    Number of hospital stays in the past 3 months

  4. curative stays

    Time frame: 3 months, 6 months

    Number of curative stays in the past 3 months

  5. doctor visits

    Time frame: 3 months, 6 months

    Number of doctor visits in the past 3 months

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • Hannover Medical School
  • University Hospital Schleswig-Holstein

Registry information

Official study title

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

Acronym: LAVENDER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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