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DIVERS-II: Treating depression in dialysis patients with a tailored eHealth cognitive based treatment: A cluster randomized controlled trial.

DIVERS-II: Treating depression in dialysis patients with a tailored eHealth cognitive based treatment: A cluster randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29658
Enrollment
206
Registered
2017-11-13
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Depressie / Depression / Depressive disorder Dialyse / Dialysis / Renal replacement therapy Nierfalen / Eindstadium nierfalen / Kidney failure / End stage renal disease

Interventions

Psychosocial intervention: Self-help cognitive based therapy, tailored for dialysis patients with build-in support from a psychotherapist. This treatment is based on a frequently used problem solving

Sponsors

OLVG Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • ≥18 years of age • undergoing dialysis treatment for at least 90 days • being able to complete a questionnaire in Dutch • have a BDI depression score of 13 or higher (BDI = Beck Depression Inventory-II)

Exclusion criteria

Exclusion criteria: • Suicidal thoughts (measurend using a short screening survey) • Participation in other psychotherapeutic trials

Design outcomes

Primary

MeasureTime frame
Cluster randomized controlled trial of the intervention versus care as usual. 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.

Secondary

MeasureTime frame
• BDI scores after 6, 12 and 18 months • Anxiety score, measured using the Beck Anxiety Inventory • Quality of life, measured using the SF-12 • Inflammatory markers, cortisol and tryptophan to explore possible pathophysiological mechanisms • Explore the effect on morbidity (hospital admissions) and mortality

Contacts

Public ContactEls Nadort

OLVG-West hospital Amsterdam

e.nadort@olvg.nl0031-20510 8911

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)