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

Stress Clinical Trial

— LAVENDER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05998161
• Other study ID #: reviga RCT 2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Gaia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Stress

Intervention

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

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Hannover Medical School, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	hospital stays	Number of hospital stays in the past 3 months	3 months, 6 months
Other	curative stays	Number of curative stays in the past 3 months	3 months, 6 months
Other	doctor visits	Number of doctor visits in the past 3 months	3 months, 6 months
Primary	Stress symptoms	Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).	3 months
Secondary	Anxiety symptoms	Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).	3 months, 6 months
Secondary	Functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).	3 months, 6 months
Secondary	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
Secondary	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
Secondary	Sick days	Number of sick days in the past 3 months	3 months, 6 months
Secondary	Stress symptoms	Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).	6 months