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

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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress; Burnout
• Intervention / Treatment: Behavioral: reviga

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antje Riepenhausen, M.Sc.; Email: antje.riepenhausen@gaia-group.com
• Study Contact Backup: Name: Gitta A. Jacob, PhD; Phone Number: +49.40.349930-374; Email: gitta.jacob@gaia-group.com

Study Locations

• Germany
  • Hamburg, Germany, 22085
    • GAIA AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: reviga + TAU; 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; Participants will receive access to the digital health intervention reviga in addition to TAU.
No Intervention: TAU; Participants allocated to the control group will receive access to treatment as usual (TAU).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).	3 months, 6 months
Effort and reward imbalance	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 months, 6 months
hospital stays	Number of hospital stays in the past 3 months	3 months, 6 months
curative stays	Number of curative stays in the past 3 months	3 months, 6 months
doctor visits	Number of doctor visits in the past 3 months	3 months, 6 months

Collaborators and Investigators

• Sponsor: Gaia AG
• Collaborators: Hannover Medical School; Universitätsklinikum Schleswig-Holstein, Campus Kiel
• Investigators: Principal Investigator: Kamila Jauch-Chara, MD, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: reviga RCT 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No