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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxio Depressive Disorder

Intervention / Treatment
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* Device: Heart rate monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients of the CHU Brugmann Hospital with an anxious or depressive disorder Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anxio-depressive patients<br>Patients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital. | Device: Heart rate monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Alexithymia scale (TAS 20) | 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) | 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) | 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) | 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 |