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

NCT05998161 | Completed

• 1 other identifier: reviga RCT 2023
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Burnout

Outcome Measures

Primary Outcomes (1)

• Stress symptoms

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

  3 months

Secondary Outcomes (6)

• Anxiety symptoms

  3 months, 6 months

• Functioning

  3 months, 6 months

• Burnout symptoms

  3 months, 6 months

• Health-related quality of life

  3 months, 6 months

• Sick days

  3 months, 6 months

Other Outcomes (5)

• Depressive symptoms

  3 months, 6 months

• Effort and reward imbalance

  3 months, 6 months

• hospital stays

  3 months, 6 months

Study Arms (2)

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.

Behavioral: reviga

TAU

NO INTERVENTION

Participants allocated to the control group will receive access to treatment as usual (TAU).

Interventions

reviga BEHAVIORAL

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

reviga + TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• consent to participation

Sponsors & Collaborators

• Gaia AG: lead
• University Hospital Schleswig-Holstein: collaborator
• Hannover Medical School: collaborator

Study Sites (1)

GAIA AG

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Kamila Jauch-Chara, MD

  Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 18, 2023
• Study Start: September 4, 2023
• Primary Completion: June 22, 2024
• Study Completion: June 22, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)