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

July 18, 2022 updated by: Tatiana Besse-Hammer

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bruxelles, Belgium
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the Psychiatry Department of the CHU Brugmann Hospital with an anxious or depressive disorder.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anxio-depressive patients
Patients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital.
The heart rate will be recorded and calculated by a heart rate monitor (Polar H10, Finland) located on the chest. The recording is done over a period of 5 minutes, the patient being in a sitting position, without any particular stimulus, in a quiet room. The recording is transferred via the HRV Logger application. Any ectopic beats and artifacts are automatically identified and replaced by values interpolated by the investigator, if necessary. The Kubios HRV Premium Software is used for all calculations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck depression inventory (BDI)
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
State trait Anxiety inventory (STAI)
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Maslach Burnout inventory (MBI)
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Root mean square of successive differences (RMSSD)
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
High frequency percentage in the spectral analysis of the heart RR interval
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toronto Alexithymia scale (TAS 20)
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
Toronto Alexithymia scale (TAS 20)
Time Frame: 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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Difficulties in Emotion Regulation Scale (DERS-18)
Time Frame: Baseline (day of inclusion of the patient in the study).
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.
Baseline (day of inclusion of the patient in the study).
Difficulties in Emotion Regulation Scale (DERS-18)
Time Frame: 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.
Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre Cole, MD, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2019

Primary Completion (ACTUAL)

July 13, 2021

Study Completion (ACTUAL)

July 13, 2021

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-PSY-BRUHRV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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