A randomized, controlled intervention study to evaluate a digital psychological intervention (DiGA) in terms of improvements in mental health, quality of life, and pain in patients with rheumatic diseases

A randomized, controlled intervention study to evaluate a digital psychological intervention (DiGA) in terms of improvements in mental health, quality of life, and pain in patients with rheumatic diseases - Rheummind

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039654

Enrollment

Registered

2026-03-18

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M32 M35

Interventions

Group 1: Interventiongroup: patients with connective tissue disease and digital health application Hello Better Stress and Burnout in combination with immunsuppressive medication Group 2: Control grou

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with diagnosis of SLE or Sjögren disease regarding ACR criterias

Exclusion criteria

Exclusion criteria: servere depression psychotherapy

Design outcomes

Primary

Measure	Time frame
1. Can the quality of life of patients with rheumatic diseases be improved within 12 weeks through the use of the HelloBetter Stress and Burnout digital health application (as measured by the SF-36 questionnaire)? 2. Can depressive symptoms, stress, and fatigue in patients with rheumatic diseases be improved within 12 weeks through the use of the HelloBetter Stress and Burnout digital health application (as measured by the BDI, PSQ, FACIT-F)? 3. Does sleep quality improve in rheumatism patients using the HelloBetter Stress and Burnout digital health application within 12 weeks (as measured by the PSQI questionnaire)? 4. Does the cognitive status of rheumatism patients improve within 12 weeks when using the HelloBetter Stress and Burnout digital health application (as measured by the Montreal Cognitive Assessment)? 5. Does the use of the HelloBetter Stress and Burnout digital health application in rheumatism patients influence pain levels and inflammation markers (as measured by the Pain VRS and CRP questionnaires)?	—

Measure

Time frame

1. Can the quality of life of patients with rheumatic diseases be improved within 12 weeks through the use of the HelloBetter Stress and Burnout digital health application (as measured by the SF-36 questionnaire)? 2. Can depressive symptoms, stress, and fatigue in patients with rheumatic diseases be improved within 12 weeks through the use of the HelloBetter Stress and Burnout digital health application (as measured by the BDI, PSQ, FACIT-F)? 3. Does sleep quality improve in rheumatism patients using the HelloBetter Stress and Burnout digital health application within 12 weeks (as measured by the PSQI questionnaire)? 4. Does the cognitive status of rheumatism patients improve within 12 weeks when using the HelloBetter Stress and Burnout digital health application (as measured by the Montreal Cognitive Assessment)? 5. Does the use of the HelloBetter Stress and Burnout digital health application in rheumatism patients influence pain levels and inflammation markers (as measured by the Pain VRS and CRP questionnaires)?

—

Secondary

Measure	Time frame
1. Is the app user-friendly (as measured by the SUS questionnaire)? 2. How well is the app accepted by rheumatology patients (as measured by NPS)? 3. Is the app used regularly (user analysis)?	—

Countries

Germany

Contacts

Public ContactHarriet Morf

Uniklinikum Erlangen

harriet.morf@uk-erlangen.de+4991318543023

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026