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

Gaia AG

Status: Completed

Conditions: Burnout; Stress

Treatments: Behavioral: reviga

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05998161

reviga RCT 2023

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

reviga + TAU

Experimental group

Description:

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.

Treatment:

Behavioral: reviga

TAU

No Intervention group

Description:

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