Heart Rate Variability in Depression

Study Overview
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Brief Summary
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The purpose of this study is to understand if there is a relationship between the way that emotions are regulated by the brain and the way that heart rate is regulated by the brain. The study also seeks to understand whether having depression changes the way that emotions and heart rate are regulated.

Official Title
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Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Video Task
* Other: Imaginal Task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-65 years Able to understand and provide informed consent Male and female Depressed Subjects: Current diagnosis of major depressive disorder (MDD) and currently in an major depressive episode (MDE) Quick Inventory of Depressive Symptomology (QIDS-SR16) score of 11 or greater Anticipated treatment with ketamine infusion for depression Exclusion Criteria: Current daily use of tricyclic antidepressants Current diagnosis of cardiac arrhythmia or heart failure Pregnancy Current use of cardiac medications of the class beta-blockers Current treatment with deep brain stimulation for any reason Healthy Controls: Current psychiatric treatment, including use of antidepressants or daily use of anxiolytic medication Depressed Subjects: Previous history of ketamine infusion for depression Psychotic symptoms Active co-morbid psychiatric diagnosis including anxiety disorder or personality disorder that significantly affects the current clinical condition, as determined by medical records

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Controls<br>Healthy controls will complete the video task and imaginal task in one session | Behavioral: Video Task<br>* Subjects are asked to watch a series of six two-minute video clips. The video clips are designed to induce sad or happy emotions or no emotion (neutral) and are taken from movies, documentaries, or instructional videos. There are two videos for each emotion condition. Videos and fixation cross screens are viewed on a laptop computer. In between video clips, patients are asked to quietly look at a fixation cross for one minute, describe their emotional reaction to the video for up to one minute, then again attend to a fixation cross for one minute. A video recording of the frontal view of the participant's face will be made during task performance.<br>Other: Imaginal Task<br>* Subjects are asked to think about happy or sad memories for 2 minutes. Subjects are asked to imagine performing neutral tasks, such as buying groceries. Subjects are then asked to think about a memory that makes them feel angry. A video recording of the frontal view of the participant's face will be made during task performance.<br>|
| Experimental: Depressed + Ketamine<br>Subjects with major depressive disorder (MDD) who are scheduled to receive ketamine infusions will complete the video task and imaginal task twice. The first visit will be before any ketamine treatment. The second visit will be within 1 week after first ketamine infusion. This is NOT at treatment study. Study inclusion is open to participants with MDD who are already planning to receive ketamine treatment at Emory. No treatment is offered through this study. | Behavioral: Video Task<br>* Subjects are asked to watch a series of six two-minute video clips. The video clips are designed to induce sad or happy emotions or no emotion (neutral) and are taken from movies, documentaries, or instructional videos. There are two videos for each emotion condition. Videos and fixation cross screens are viewed on a laptop computer. In between video clips, patients are asked to quietly look at a fixation cross for one minute, describe their emotional reaction to the video for up to one minute, then again attend to a fixation cross for one minute. A video recording of the frontal view of the participant's face will be made during task performance.<br>Other: Imaginal Task<br>* Subjects are asked to think about happy or sad memories for 2 minutes. Subjects are asked to imagine performing neutral tasks, such as buying groceries. Subjects are then asked to think about a memory that makes them feel angry. A video recording of the frontal view of the participant's face will be made during task performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate variability (HRV, also called RSA) | HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means of electrocardiogram (EKG). Change is the difference from between HRV at baseline and after video task. | Baseline, Post-Video Task Session 1 (30 minutes) | 
| Change in heart rate variability (HRV, also called RSA) | HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means of electrocardiogram (EKG). Change is the difference from between HRV at baseline and after the imaginal task. | Baseline, Post-Imaginal Task Session 1 (6 minutes) | 
| Change in heart rate variability (HRV, also called RSA) | HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means of electrocardiogram (EKG). Change is the difference from between HRV at baseline and after video task one week post-infusion. | Baseline, Post-Video Task Session 2 (30 minutes) | 
| Change in heart rate variability (HRV, also called RSA) | RSA is measured by changes in the R-R interval (time between two of the distinctive, large, upward R spikes on an electrocardiogram (EKG)) synchronized with respiration. Change is the difference from between RSA at baseline and after imaginal task one week post-infusion. | Baseline, Post-Imaginal Task Session 2 (6 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean values of positive emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Video Task Session 1 (30 minutes) | 
| Mean values of positive emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Imaginal Task Session 1 (6 minutes) | 
| Mean values of negative emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Video Task Session 1 (30 minutes) | 
| Mean values of negative emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Imaginal Task Session 1 (6 minutes) | 
| Mean values of positive emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Video Task Session 2 (30 minutes) | 
| Mean values of positive emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Imaginal Task Session 2 (6 minutes) | 
| Mean values of negative emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Video Task Session 2 (30 minutes) | 
| Mean values of negative emotional expressions | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative). | Post-Imaginal Task Session 2 (6 minutes) | 
| Mean activation of muscle action units | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the activation of facial muscle action units. | Post-Video Task Session 1 (30 minutes) | 
| Mean activation of muscle action units | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the activation of facial muscle action units associated with smiling. | Post-Imaginal Task Session 1 (6 minutes) | 
| Mean activation of muscle action units | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the activation of facial muscle action units associated with smiling. | Post-Video Task Session 2 (30 minutes) | 
| Mean activation of muscle action units | Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the activation of facial muscle action units associated with smiling. | Post-Imaginal Task Session 2 (6 minutes) | 
| Change in heart rate | Heart rate will be measured with the electrocardiogram (EKG) and recorded in beats per minute. Change is the difference from between heart rate at baseline and after the video task. | Baseline, Post-Video Task Session 1 (30 minutes) | 
| Change in heart rate | Heart rate will be measured with the electrocardiogram (EKG) and recorded in beats per minute. Change is the difference from between heart rate at baseline and after the imaginal task. | Baseline, Post-Imaginal Task Session 1 (6 minutes) | 
| Change in heart rate | Heart rate will be measured with the electrocardiogram (EKG) and recorded in beats per minute. Change is the difference from between heart rate at baseline and after the video task one week post-infusion. | Baseline, Post-Video Task Session 2 (30 minutes) | 
| Change in heart rate | Heart rate will be measured with the electrocardiogram (EKG) and recorded in beats per minute. Change is the difference from between heart rate at baseline and after the imaginal task one week post-infusion. | Baseline, Post-Imaginal Task Session 2 (6 minutes) | 
| Change in skin conductance response (SCR) | The skin conductance will be measured between two leads attached to the participant's the left and right palms which records electrodermal measures. Change is the difference from between SCR at baseline and after the video task. | Baseline, Post-Video Task Session 1 (30 minutes) | 
| Change in skin conductance response (SCR) | The skin conductance will be measured between two leads attached to the participant's the left and right palms which records electrodermal measures. Change is the difference from between SCR at baseline and after the imaginal task. | Baseline, Post-Imaginal Task Session 1 (6 minutes) | 
| Change in skin conductance response (SCR) | The skin conductance will be measured between two leads attached to the participant's the left and right palms which records electrodermal measures. Change is the difference from between SCR at baseline and after the video task one week post-infusion. | Baseline, Post-Video Task Session 2 (30 minutes) | 
| Change in skin conductance response (SCR) | The skin conductance will be measured between two leads attached to the participant's the left and right palms which records electrodermal measures. Change is the difference from between SCR at baseline and after the imaginal task one week post-infusion. | Baseline, Post-Imaginal Task Session 2 (6 minutes) | 
| Change in respiration rate | The respiration rate will be measured by the respiration monitor belt and recorded as number of breaths per minute. Change is the difference from between respiration rate at baseline and after the video task. | Baseline, Post-Video Task Session 1 (30 minutes) | 
| Change in respiration rate | The respiration rate will be measured by the respiration monitor belt and recorded as number of breaths per minute. Change is the difference from between respiration rate at baseline and after the imaginal task. | Baseline, Post-Imaginal Task Session 1 (6 minutes) | 
| Change in respiration rate | The respiration rate will be measured by the respiration monitor belt and recorded as number of breaths per minute. Change is the difference from between respiration rate at baseline and after the video task one week post-infusion. | Baseline, Post-Video Task Session 2 (30 minutes) | 
| Change in respiration rate | The respiration rate will be measured by the respiration monitor belt and recorded as number of breaths per minute. Change is the difference from between respiration rate at baseline and after the imaginal task one week post-infusion. | Baseline, Post-Imaginal Task Session 2 (6 minutes) | 
| Change in pulse rate | The peripheral pulse rate will be measured by pulse oximeters placed on one finger on the left and right hands. Change is the difference from between pulse rate at baseline and after the video task. | Baseline, Post-Video Task Session 1 (30 minutes) | 
| Change in pulse rate | The peripheral pulse rate will be measured by pulse oximeters placed on one finger on the left and right hands. Change is the difference from between pulse rate at baseline and after the imaginal task. | Baseline, Post-Imaginal Task Session 1 (6 minutes) | 
| Change in pulse rate | The peripheral pulse rate will be measured by pulse oximeters placed on one finger on the left and right hands. Change is the difference from between pulse rate at baseline and after the video task one week post-infusion. | Baseline, Post-Video Task Session 2 (30 minutes) | 
| Change in pulse rate | The peripheral pulse rate will be measured by pulse oximeters placed on one finger on the left and right hands. Change is the difference from between pulse rate at baseline and after the imaginal task one week post-infusion. | Baseline, Post-Imaginal Task Session 2 (6 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Rate