Heart Rate Variability in Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Video Task; Other: Imaginal Task

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30329
      • 12 Executive Park Drive
    • Atlanta, Georgia, United States, 30329
      • Emory University at Wesley Woods Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Controls; Healthy controls will complete the video task and imaginal task in one session	Behavioral: Video Task; 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.; Other: Imaginal Task; 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.
Experimental: Depressed + Ketamine; 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; 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.; Other: Imaginal Task; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Andrea Crowell, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): April 12, 2017
• Study Completion (Actual): April 12, 2017

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Heart Rate
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: IRB00082047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No