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

NCT04192669 | Completed

• 1 other identifier: CHUB-PSY-BRUHRV
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxio Depressive Disorder

Outcome Measures

Primary Outcomes (10)

• Beck depression inventory (BDI)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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

  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

  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 Outcomes (4)

• Toronto Alexithymia scale (TAS 20)

  Baseline (day of inclusion of the patient in the study).

• 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)

  Baseline (day of inclusion of the patient in the study).

• 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 Arms (1)

Anxio-depressive patients

Patients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital.

Device: Heart rate monitoring

Interventions

Heart rate monitoring DEVICE

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.

Anxio-depressive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Tatiana Besse-Hammer: lead

Study Sites (1)

CHU Brugmann

Brussels, Belgium

Location

MeSH Terms

Interventions

Heart Rate Determination

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Pierre Cole, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical research unit

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: November 11, 2019
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)