DIVERS-II: Treating depression in dialysis patients with a tailored eHealth cognitive based treatment: A cluster randomized controlled trial.
Recruiting
- Conditions
- Depressie / Depression / Depressive disorderDialyse / Dialysis / Renal replacement therapyNierfalen / Eindstadium nierfalen / Kidney failure / End stage renal disease
- Registration Number
- NL-OMON29658
- Lead Sponsor
- OLVG Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 206
Inclusion Criteria
• ≥18 years of age
• undergoing dialysis treatment for at least 90 days
Exclusion Criteria
• Suicidal thoughts (measurend using a short screening survey)
• Participation in other psychotherapeutic trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cluster randomized controlled trial of the intervention versus care as usual.<br /><br>The primary outcome is the depression score, measured using the Beck Depression Inventory (BDI). The difference between T0 and T1 (1-2 weeks after treatment) is the primary outcome for clinical effectiveness. Care as usual will be compared with the intervention group.<br>
- Secondary Outcome Measures
Name Time Method • BDI scores after 6, 12 and 18 months<br /><br>• Anxiety score, measured using the Beck Anxiety Inventory<br /><br>• Quality of life, measured using the SF-12<br /><br>• Inflammatory markers, cortisol and tryptophan to explore possible pathophysiological mechanisms<br /><br>• Explore the effect on morbidity (hospital admissions) and mortality