The influence of cognitive behavioural therapy for insomnia (CBT-I) on the pathophysiology of major depressive disorder: A pilot study

The influence of cognitive behavioural therapy for insomnia (CBT-I) on the pathophysiology of major depressive disorder: A pilot study - The influence of CBT-I on MDD pathophysiology

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56549

Enrollment

Registered

2023-12-22

Start date

2025-01-28

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

Depression insomnia sleep disturbance.

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 years or older. - Primary diagnosis for MDD (without psychotic features) based on Diagnostic and Statistical Manual 5th edition (DSM-5) criteria ascertained by the Mini International Neuropsychiatric Interview (MINI). - Co-morbid clinical insomnia (ISI >= 15) - Stable pharmacological treatment for MDD. This pertains to all medication described in the clinical guideline for the treatment of MDD including antidepressant monotherapy, combination therapy (i.e., multiple antidepressants provided simultaneously), and augmentation therapy (i.e., antidepressants combined with lithium or atypical antipsychotics). No changes in pharmacological MDD treatment (type and dosage) should be anticipated during the study period or present within the four weeks prior to participation.

Exclusion criteria

Exclusion criteria: - Comorbid diagnoses for a psychiatric disorder within one of the following diagnostic groups: o Bipolar disorders o Schizophrenia or other psychotic disorders o Delirium, dementia, and amnestic and other cognitive disorders o Substance use disorder - Current or recent (four weeks prior to inclusion) use of non-prescribed psychoactive compounds (i.e., recreational drugs, herbal medicine etc.) not including caffeine and alcohol. - Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
The primary study parameter comprises the mean change in serum levels of neuroendocrine (i.e., cortisol), immunologic (i.e., c-reactive protein, CRP; interleukin-6, IL-6; tumour necrosis factor alpha, TNF-alpha), neurotrophic (i.e., brain derived neurotrophic factor, BDNF), and metabolic (i.e., leptin) biomarkers before and after five weeks of CBT-I treatment.	—

Secondary

Measure	Time frame
Secondary study parameters comprise the mean change in the severity of insomnia (Insomnia Severity index, ISI) and depression (Inventory Depressive Symptoms Self-Report, IDS-SR) before and after five weeks of CBT-I treatment as well as the respective correlation of the difference in insomnia and depression severity with the change in the serum levels of the included biomarkers (see: 8.1.1 Main study parameter/endpoint).	—

Measure

Time frame

Secondary study parameters comprise the mean change in the severity of insomnia (Insomnia Severity index, ISI) and depression (Inventory Depressive Symptoms Self-Report, IDS-SR) before and after five weeks of CBT-I treatment as well as the respective correlation of the difference in insomnia and depression severity with the change in the serum levels of the included biomarkers (see: 8.1.1 Main study parameter/endpoint).

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Countries

Netherlands

Outcome results