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Clinical Trials/NCT04192669
NCT04192669
Completed
Not Applicable

Study of Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients

Tatiana Besse-Hammer1 site in 1 country44 target enrollmentNovember 11, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxio Depressive Disorder
Sponsor
Tatiana Besse-Hammer
Enrollment
44
Locations
1
Primary Endpoint
Beck depression inventory (BDI)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2019
End Date
July 13, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tatiana Besse-Hammer
Responsible Party
Sponsor Investigator
Principal Investigator

Tatiana Besse-Hammer

Head of clinical research unit

Brugmann University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Beck depression inventory (BDI)

Time Frame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

Multiple choice (4 choices) questionnaire with 21 items. The end score can vary between 0 and 63. Score interpretation: 1-10: These ups and downs are considered normal. 11-16 Mild mood disturbance. 17-20 Borderline clinical depression. 21-30 Moderate depression. 31-40 : Severe depression. Over 40 :Extreme depression.

State trait Anxiety inventory (STAI)

Time Frame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Maslach Burnout inventory (MBI)

Time Frame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

The Maslach Burnout Inventory (MBI) is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout. All MBI items are scored using a 7 level frequency scale from "never" to "daily." Initial development had 3 components: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Scales should not be combined to form a single burnout scale.

Root mean square of successive differences (RMSSD)

Time Frame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

The Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR intervals. It reflects the activity of the parasympathetic nervous system.

High frequency percentage in the spectral analysis of the heart RR interval

Time Frame: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

Spectral analysis of the RR interval is an indirect, noninvasive measurement tool of heart rate variability. High-frequency RR signals (0.15 to 0.4 Hz) reflect a parasympathetic activity and thus an influence of the vagal nerve on the heart. A high frequency heart variability is associated with a better perception of emotions and with pro-social behaviors.

Secondary Outcomes

  • Toronto Alexithymia scale (TAS 20)(Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline)
  • Difficulties in Emotion Regulation Scale (DERS-18)(Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline)

Study Sites (1)

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