|- candidate number||28195|
|- NTR Number||NTR6834|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-nov-2017|
|- Secondary IDs||METC: NL58520.100.17 OLVG: WO 17.162|
|- Public Title||DIVERS-II: Treating depression in dialysis patients with a tailored eHealth cognitive based treatment: A cluster randomized controlled trial.|
|- Scientific Title||DIVERS-II: Treating depression in dialysis patients with a tailored eHealth cognitive based treatment: A cluster randomized controlled trial.|
|- ACRONYM||DIVERS-II (Internet Intervention)|
|- Healt Condition(s) or Problem(s) studied||Depression, Dialysis patients, Renal disease|
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-jan-2020|
|- Target number of participants||206|
|- 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 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 as provided by nephrologist, social workers and if applicable psychotherapists. This group will receive an online infomodule
about depression in end-stage-renal-disease.
|- 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
|- Timepoints||T0: Baseline (before randomization)|
T1: Within 1-2 weeks after the intervention
T2: 6 months
T3: 12 months
T4: 18 months
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||drs. Robbert Schouten|
|- CONTACT for SCIENTIFIC QUERIES|| C. Siegert|
|- Sponsor/Initiator ||OLVG|
(Source(s) of Monetary or Material Support)
|ZonMw projectnummer 843001804, OLVG WO 17.162, Stichting Zabawas|
|- Brief 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.
To deliver an easy accessible, patient friendly and low-cost self-help intervention for the treatment of depressive symptoms in dialysis patients.
An eHealth CBT in tervention reduces depressive symptoms in dialysis patients.
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.
|- Main changes (audit trail)|
|- RECORD||13-nov-2017 - 7-dec-2017|