search
Back to results

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

Primary Purpose

Stress, Burnout

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
reviga
Sponsored by
Gaia AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GAIA AGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

reviga + TAU

TAU

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anxiety symptoms
Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).
Functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Burnout symptoms
Oldenburg Burnout Inventory (OLBI). Two subscales (exhaustion and disengagement), each ranging from 8-32; higher scores mean higher burnout symptoms (worse outcome).
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).
Sick days
Number of sick days in the past 3 months
Stress symptoms
Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).

Full Information

First Posted
August 9, 2023
Last Updated
September 11, 2023
Sponsor
Gaia AG
Collaborators
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Hannover Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT05998161
Brief Title
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
Official Title
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaia AG
Collaborators
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
reviga + TAU
Arm Type
Experimental
Arm 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.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Participants allocated to the control group will receive access to treatment as usual (TAU).
Intervention Type
Behavioral
Intervention Name(s)
reviga
Intervention Description
Participants will receive access to the digital health intervention reviga in addition to TAU.
Primary Outcome Measure Information:
Title
Stress symptoms
Description
Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Anxiety symptoms
Description
Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).
Time Frame
3 months, 6 months
Title
Functioning
Description
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Time Frame
3 months, 6 months
Title
Burnout symptoms
Description
Oldenburg Burnout Inventory (OLBI). Two subscales (exhaustion and disengagement), each ranging from 8-32; higher scores mean higher burnout symptoms (worse outcome).
Time Frame
3 months, 6 months
Title
Health-related quality of life
Description
Assessment of Quality of Life - 8D (AQoL-8D). AQoL-8D score ranging from 0-100; higher scores mean higher quality of life (better outcome).
Time Frame
3 months, 6 months
Title
Sick days
Description
Number of sick days in the past 3 months
Time Frame
3 months, 6 months
Title
Stress symptoms
Description
Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Depressive symptoms
Description
Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).
Time Frame
3 months, 6 months
Title
Effort and reward imbalance
Description
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).
Time Frame
3 months, 6 months
Title
hospital stays
Description
Number of hospital stays in the past 3 months
Time Frame
3 months, 6 months
Title
curative stays
Description
Number of curative stays in the past 3 months
Time Frame
3 months, 6 months
Title
doctor visits
Description
Number of doctor visits in the past 3 months
Time Frame
3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitta A. Jacob, PhD
Phone
+49.40.349930-374
Email
gitta.jacob@gaia-group.com
First Name & Middle Initial & Last Name or Official Title & Degree
Antje Riepenhausen, M.Sc.
Email
antje.riepenhausen@gaia-group.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamila Jauch-Chara, MD
Organizational Affiliation
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
GAIA AG
City
Hamburg
ZIP/Postal Code
22085
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitta A. Jacob, PhD
Email
gitta.jacob@gaia-group.com
First Name & Middle Initial & Last Name & Degree
Antje Riepenhausen, M.Sc.
Email
antje.riepenhausen@gaia-group.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs