DIVERS-II: Internet Intervention Self-help Cognitive Behavioural Therapy for depressive symptoms in dialysis patients: a randomized controlled trial.

Recruiting

Conditions: Depression
mood disorder
10027946
10038430

Registration Number: NL-OMON55601

Lead Sponsor: OLVG

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
* being able to complete a questionnaire in Dutch
* have a BDI score of 10 or higher

Exclusion Criteria

* Suicidal thoughts
* Participation in other psychotherapeutic trials

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>To investigate the clinical and cost-effectiveness of a self-help cognitive<br /><br>behavioural therapy in lowering depressive symptoms.<br /><br><br /><br>Hypothesis:<br /><br>Our eHealth intervention reduces depressive symptoms more than in the<br /><br>care-as-usual group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>- To examine the changes in inflammatory and stress parameters before<br /><br>and after the intervention.<br /><br>- To investigate the effectiveness in improving Quality of Life scores.<br /><br>- To explore the effect on morbidity and mortality.<br /><br><br /><br>Psychosocial: Depressive symptoms scale (BDI-II, HADS-D, MINI-plus)<br /><br>Symptoms, severity and subtyping depression (IDS-SR)<br /><br>Quality of Life (SF-12)<br /><br>Anxiety symptoms (BAI, HADS-A, MINI-plus)<br /><br>COVID-19 stress (PSQ-10)<br /><br>Clinical: Baseline data from patient file including laboratory measurements<br /><br>Hospitalization<br /><br>Mortality<br /><br>Biochemical: Inflammatory markers (IL-1, IL-6, IL-10, TNF-, hs-CRP)<br /><br>Cortisol (sample hair cortisol which displays mean cortisol for the<br /><br>past 3 months)<br /><br>Tryptophan (serum tryptophan, KYN and 3-hydroxykynrenin)</p><br>