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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55601

Enrollment

206

Registered

2017-11-10

Start date

2018-01-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Depression mood disorder

Interventions

The intervention consists of five modules with explanatory text, figures and exercises. Patients are asked to examine 1 module per week and work on their assignments for at least 2 hours per week. P

Eligibility

Age

18 Years to 99 Years

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 score of 10 or higher

Exclusion criteria

Exclusion criteria: * Suicidal thoughts * Participation in other psychotherapeutic trials

Design outcomes

Primary

Measure	Time frame
Primary Objective: To investigate the clinical and cost-effectiveness of a self-help cognitive behavioural therapy in lowering depressive symptoms. Hypothesis: Our eHealth intervention reduces depressive symptoms more than in the care-as-usual group.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)