Clinical trial NCT04192669: Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients
Official title: Study of Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxio Depressive Disorder
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Psychiatry Department of the CHU Brugmann Hospital with an anxious or depressive disorder.

Brief summary: The heart rate (HR) is regulated by the autonomic nervous system (ANS) and results from a balance between the sympathetic nervous system (SNS) that accelerates the heart rate and the parasympathetic nervous system that slows the HR via the vagus nerve.

Low HRV is linked to poor emotional and cognitive regulation. Values for HRV are generally lower in depressed patients.

The aim of this study is to determine how HRV could be a clinical marker that can be used in routine psychiatry practice in patients with anxio-depressive disorders, to determine the severity of symptoms and the degree of response to treatment.


Eligibility criteria: Inclusion Criteria:

- Patients of the CHU Brugmann Hospital with an anxious or depressive disorder

Exclusion Criteria:

- None

Primary outcomes:
measure: Beck depression inventory (BDI)
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: Beck depression inventory (BDI)
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
measure: State trait Anxiety inventory (STAI)
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: State trait Anxiety inventory (STAI)
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
measure: Maslach Burnout inventory (MBI)
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: Maslach Burnout inventory (MBI)
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
measure: Root mean square of successive differences (RMSSD)
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: Root mean square of successive differences (RMSSD)
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
measure: High frequency percentage in the spectral analysis of the heart RR interval
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: High frequency percentage in the spectral analysis of the heart RR interval
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Secondary outcomes:
measure: Toronto Alexithymia scale (TAS 20)
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: Toronto Alexithymia scale (TAS 20)
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
measure: Difficulties in Emotion Regulation Scale (DERS-18)
timeFrame: Baseline (day of inclusion of the patient in the study).
measure: Difficulties in Emotion Regulation Scale (DERS-18)
timeFrame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Pierre Cole, MD
role: PRINCIPAL_INVESTIGATOR
References: