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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05998161
Other study ID # reviga RCT 2023
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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