Anxio Depressive DisorderNCT04192669
Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients
An observational study of Anxio Depressive Disorder, run by Tatiana Besse-Hammer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxio Depressive Disorder
- What is being tested?
- Heart rate monitoring
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Nov 2019to 13 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Psychiatry Department of the CHU Brugmann Hospital with an anxious or depressive disorder.
Who may be able to join
- Patients of the CHU Brugmann Hospital with an anxious or depressive disorder
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxio Depressive Disorder
- Being tested
- Heart rate monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Anxio-depressive patients | Patients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital. Receives: Device: Heart rate monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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.
Measured: 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: 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.
Measured: 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: 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.
Measured: 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: 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.
Measured: 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: 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)
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: 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: 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.
Measured: 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: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start11 Nov 2019
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxio Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatiana Besse-Hammer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Pierre Cole, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192669
- Sponsor's protocol ID
- CHUB-PSY-BRUHRV
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients
- ClinicalTrials.gov ID
- NCT04192669
- Acronym / sponsor ID
- CHUB-PSY-BRUHRV
- Conditions
- Anxio Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tatiana Besse-HammerUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxio-depressive patients | – | Device: Heart rate monitoringPatients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Psychiatry Department of the CHU Brugmann Hospital with an anxious or depressive disorder.
Key inclusion criteria (1 listed)
- Patients of the CHU Brugmann Hospital with an anxious or depressive disorder
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate monitoringThe 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. | Device | Anxio-depressive patients |
Primary outcome
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.
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: 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.
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: 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.
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: 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.
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: 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.
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.
4 secondary outcomes
Toronto Alexithymia scale (TAS 20)
Time frame: 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
Difficulties in Emotion Regulation Scale (DERS-18)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Anxio Depressive Disorder
RecruitingObservational study
Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
Anorexia Nervosa, Dysbiosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Cole, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxio Depressive Disorder, run by Tatiana Besse-Hammer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck depression inventory (BDI) (time frame: Baseline (day of inclusion of the patient in the study).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.