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

Completed

• Conditions: Anxio Depressive Disorder
• Interventions: Device: Heart rate monitoring

• Registration Number: NCT04192669
• Lead Sponsor: Tatiana Besse-Hammer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anxio-depressive patients	Heart rate monitoring	Patients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital.

Primary Outcome Measures

Name	Time	Method
Beck depression inventory (BDI)	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)	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)	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)	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	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 Outcome Measures

Name	Time	Method
Toronto Alexithymia scale (TAS 20)	Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline	The TAS is a 20-item instrument that is one of the most commonly used measures of alexithymia. Alexithymia refers to people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Difficulties in Emotion Regulation Scale (DERS-18)	Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline	The Difficulties in Emotion Regulation Scale is a self-report measure that evaluates individuals' levels of difficulties in regulating emotions.Higher scores indicate more difficulty in emotion regulation.

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Bruxelles, Belgium