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).
Not Applicable
- Conditions
- rheumatoid arthritis (RA), psoriatic arthritis (PsA) or systemic lupus erythematosus (SLE)
- Registration Number
- DRKS00032862
- Lead Sponsor
- Vila Health UG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 102
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in psychological distress (HADS-D) and quality of life (AQoL-8D)
- Secondary Outcome Measures
Name Time Method Self-efficacy (SES6G)<br>Health literacy (HLS-EU-Q16)<br>Stress level (PSS-10)<br>Work Ability and social function (WSAS)<br>Depression severity (PHQ-9)<br>Anxiety severity (GAD-7)<br><br>Data collection at specified time points (screening, T0 - baseline, T1 - 6 weeks, and T2 - 12 weeks)