The objective of the present study is to investigate the influence of CBT-I on the serum levels of MDD biomarkers pertaining to the neuroendocrine, immunologic, neurotrophic, and metabolic hypotheses of MDD (primary objective) and explore whether…
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Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Insomnia represents a common sleep disorder in patients with Major Depressive
Disorder (MDD). It has been well-established that insomnia contributes to the
aetiology of MDD and negatively impacts the clinical course. In line with these
findings, increasing evidence suggests that insomnia is associated with
neurobiological alterations that resemble the pathophysiology of MDD. However,
studies in clinical populations are limited and it is unknown whether the
treatment of insomnia may reverse such neurobiological alterations. The present
study therefore aims to investigate the influence of the first-line treatment
for insomnia, Cognitive Behavioural Therapy for Insomnia (CBT-I), on the main
pathophysiological mechanisms of MDD in a clinical sample of MDD patients.
Study objective
The objective of the present study is to investigate the influence of CBT-I on
the serum levels of MDD biomarkers pertaining to the neuroendocrine,
immunologic, neurotrophic, and metabolic hypotheses of MDD (primary objective)
and explore whether changes in insomnia severity following CBT-I are associated
with alterations in the serum levels of the included biomarkers (secondary
objective). It is hypothesized that CBT-I results in a normalisation of MDD
pathophysiology.
Study design
The proposed study comprises a prospective observational cohort study. MDD
patients who receive CBT-I as part of usual care will be assessed for insomnia
(Insomnia Severity Index, ISI) and depression severity (Inventory Depressive
Symptoms Self-Report, IDS-SR) before treatment initiation (baseline) and after
five weeks of treatment (follow-up) using self-reported questionnaires. Serum
levels of well-established MDD biomarkers will be evaluated in blood samples
collected at both time points.
Study burden and risks
Given the observational nature of the study there are no anticipated risks or
benefits related to study participation. Patients receive the recommended
first-line treatment for insomnia (CBT-I) as part of usual care which has been
associated with more favourable treatment outcomes in MDD. The burden for
participants concerns one visit (15-30 min) prior (baseline) and one visit
(15-30 min) following (follow-up) five weeks of CBT-I treatment for the
completion of questionnaires (demographic characteristics, clinical
characteristics, current treatment, ISI, IDS-SR) and blood sample collection
(10 ml).
Hanzeplein 1
Groningen 9713 RB
NL
Hanzeplein 1
Groningen 9713 RB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84859.042.23 |