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

Conditions: Depression
insomnia
sleep disturbance.
10027946

Registration Number: NL-OMON56549

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 34

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

- 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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