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A pilot randomised controlled trial to test the efficacy of an online-program on disease-related psychological distress and quality of life in patients with chronic inflammatory rheumatic disease (RELIEVE).

A pilot randomised controlled trial to test the efficacy of an online-program on disease-related psychological distress and quality of life in patients with chronic inflammatory rheumatic disease (RELIEVE). - RELIEVE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032862
Enrollment
102
Registered
2024-01-05
Start date
2024-02-22
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

rheumatoid arthritis (RA), psoriatic arthritis (PsA) or systemic lupus erythematosus (SLE)

Interventions

Group 1: Intervention group (IG) Access to the online program Vila RaVie and care as usual Group 2: Control group (CG) Standard treatment (care as usual) and information provision (flyer about mental

Sponsors

Vila Health UG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Medical diagnosis 2. Disease-related psychological distress 3. Access to the internet via PC, laptop, tablet, or smartphone and valid private e-mail address. 4. Sufficient knowledge of the German language as assessed by the investigator. 5. Provision of written informed consent for the use of the data.

Exclusion criteria

Exclusion criteria: 1. Currently undergoing psychotherapeutic treatment 2. Psychotherapy in the last 6 months 3. Suicidality 4. Acute mental crisis 5. Motor or mental impairment that makes independent use of the online program difficult/impossible

Design outcomes

Primary

MeasureTime frame
Change in psychological distress (HADS-D) and quality of life (AQoL-8D)

Secondary

MeasureTime frame
Self-efficacy (SES6G) Health literacy (HLS-EU-Q16) Stress level (PSS-10) Work Ability and social function (WSAS) Depression severity (PHQ-9) Anxiety severity (GAD-7) Data collection at specified time points (screening, T0 - baseline, T1 - 6 weeks, and T2 - 12 weeks)

Countries

Germany

Outcome results

None listed

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