No registrations found.
ID
Source
Brief title
Health condition
Depressie / Depression / Depressive disorder
Dialyse / Dialysis / Renal replacement therapy
Nierfalen / Eindstadium nierfalen / Kidney failure / End stage renal disease
Sponsors and support
OLVG WO 17.162
Stichting Zabawas
Intervention
Outcome measures
Primary outcome
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 outcome
• 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
Background summary
Background:
Depressive symptoms are highly prevalent in dialysis patients and associated with adverse outcomes. However,
depression is underdiagnosed and undertreated in this population. There is lack of robust randomized controlled
trials relating to the effectiveness of therapeutic interventions. This study aims to investigate the effectiveness of
an eHealth self-help intervention for depressive symptoms in dialysis patients. Furthermore, the biochemical
changes and associations involved in depression in dialysis patients are examined.
This study can provide an accessible, patient friendly, low-cost intervention for the tr eatment of depressive
symptoms and improving quality of life of dialysis patients.
Primary objective:
To deliver an easy accessible, patient friendly and low-cost self-help intervention for the treatment of depressive symptoms in dialysis patients.
Main hypothesis:
An eHealth CBT intervention reduces depressive symptoms in dialysis patients.
Objective:
1. To investigate the effectiveness of a self-help CBT in lowering depressive symptoms and the associated adverse outcomes.
2. To examine the biochemical mechanisms involved in treating depression.
Study objective
An eHealth CBT intervention reduces depressive symptoms in dialysis patients.
Study design
T0: Baseline (before randomization)
T1: Within 1-2 weeks after the intervention
T2: 6 months
T3: 12 months
T4: 18 months
Intervention
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 therapy. It is offered through both an e-health portal and on paper, depending on the preference of the patient. The intervention consists of 5 modules with explanatory texts and animations, exercises and weekly feedback from a trained psychotherapist.
Care-as-usual:
Care as usual as provided by nephrologist, social workers and if applicable psychotherapists. This group will receive an online infomodule
about depression in end-stage-renal-disease.
Els Nadort
Jan Tooropstraat 164
Amsterdam 1061 AE
The Netherlands
0031-20510 8911
e.nadort@olvg.nl
Els Nadort
Jan Tooropstraat 164
Amsterdam 1061 AE
The Netherlands
0031-20510 8911
e.nadort@olvg.nl
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
• Suicidal thoughts (measurend using a short screening survey)
• Participation in other psychotherapeutic trials
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6648 |
| NTR-old | NTR6834 |
| Other | OLVG: WO 17.162 : METC: NL58520.100.17 |