Voice Changes During ECT

Completed

• Conditions: Bipolar Depression; Unipolar Depression; Bipolar Disorder, Manic
• Interventions: Other: Questionnaire

• Registration Number: NCT04420793
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or quantify exactly what has changed in their speech and voice. The study team will choose ECT as it is one of the most effective and rapid treatment for depression. The study team will use a service provided by a company, NeuroLex, who has complex computer programs (artificial intelligence, AI) to analyze the voice samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-07
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-09
• Primary Completion: 2021-02-17
• Study Completion: 2021-02-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECT and Voice Recorded Group	Questionnaire	This is an add-on study of voice samples to be gathered during ECT clinical treatments. The ONLY research procedures are four tasks on an online form, one text task and three voice recording tasks. These voice recordings will take place in a private room on the 5th floor of the Institute of Psychiatry on the same day of a patient's ECT treatment. The questionnaire will take less than 10 minutes.

Primary Outcome Measures

Name	Time	Method
Meta-features: fatigue	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate binary outcome: fatigued or awake
Meta-features: audio quality	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate binary outcome: bad or good
Acoustic feature: zero crossing rate	Throughout a course of electroconvulsive therapy (ECT) which may last between 2 and 7 weeks.	crossings per second
Meta-features: sentiment	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate binary outcome: sad or happy
Meta-features: accent	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate a categorical outcome of accent region: england, indian, australian, etc.
Comparing the voice feature(s) with greatest statistically significant change to Patient Health Questionnaire (PHQ)-9 scores	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	The voice feature(s) found to have changed most significantly will be compared to Patient Health Questionnaire-9 scores which approach a total score that is less than 8, indicative of reduced depressive symptoms throughout Electroconvulsive Therapy
Acoustic feature: spectral centroid, spectral spread, spectral entropy, spectral flux, spectral rolloff	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	hertz
Acoustic feature: Mel-Frequency Cepstral Coefficients, Chroma Vectors, and Chroma Deviation	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	unitless
Linguistic features: question ratio, filler ratio, number ratio, type token ratio	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	unitless ratio
Linguistic features: standardized word entropy	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	decibels/log(total word count)
Meta-features: stress	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate binary outcome: stressed or not stressed
Meta-features: gender	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate binary outcome: male or female
Acoustic Feature Specific Changes within and across sessions	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Generalized mixed linear model will be used to evaluate which acoustic features change with P value threshold of \<0.05
Meta-Feature Specific Changes within and across sessions	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Generalized mixed linear model will be used to evaluate which meta features change with P value threshold of \<0.05
Meta-features: length	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	seconds
Linguistic Feature Specific Changes within and across sessions	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Generalized mixed linear model will be used to evaluate which linguistic features change with P value threshold of \<0.05
Acoustic feature: energy and entropy	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	decibels
Linguistic features: Brunets index	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	W (lexical richness)
Linguistic features: Honores statistic	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	R (lexical richness)
Meta-features: age	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Machine learning approach to evaluate estimated decade-age: 10s, 20s, 30s, 40s, 50s, 60s, 70s, 80s, 90s, etc.
Linguistic features: verb frequency, noun frequency, pronoun frequency, adverb frequency, adjective frequency, particle frequency, conjunction frequency, pronoun frequency	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	percentage
Linguistic features: rate of speech	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	words per minute

Secondary Outcome Measures

Name	Time	Method
Patient Chart Review Data: Current non-psychiatric Medications	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Patient Chart Review Data: Psychiatric diagnosis for ECT	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Diagnosis indicated for receiving ECT
Patient Chart Review Data: Family Psychiatric History	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Categorical regarding psychiatric diagnoses of family members
Patient Chart Review Data: Prior ECT treatment	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Binary (yes/no)
Patient Chart Review Data: Past Psychiatric Medication Trials	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Patient Chart Review Data: Classes of Current Psychiatric Medications	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Categorical: Sedative, Selective Serotonin Reuptake Inhibitor, etc.
Patient Chart Review Data: PHQ-9 score at each session	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Total (0-27) on 9 question scale
Patient Chart Review Data: Suicidal Ideation at ECT consult	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Binary: yes/no
Patient Chart Review Data: Number of non-psychiatric medical diagnoses	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Patient Chart Review Data: total # of prior ECT treatments for response in the past	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Numerical
Patient Chart Review Data: Psychiatric hospitalizations	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Patient Chart Review Data: Age	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	years
Patient Chart Review Data: gender	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	male, female, unspecified
Patient Chart Review Data: race	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	african american, caucasian, hispanic, asian american, etc.
Acoustic Feature Specific Changes between sessions	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Acoustic voice features will be evaluated using continuous averages using one sample t-tests and we will be testing the difference over time to a null hypothesis of 0 (for no change) in the one sample t-test.
Linguistic Feature Specific Changes between sessions	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Linguistic voice features will be evaluated using continuous averages using one sample t-tests and we will be testing the difference over time to a null hypothesis of 0 (for no change) in the one sample t-test.
Meta-Feature Specific Changes between sessions	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Meta-voice features will be evaluated using continuous averages using one sample t-tests and we will be testing the difference over time to a null hypothesis of 0 (for no change) in the one sample t-test.
Patient Chart Review Data: inpatient/outpatient status	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	binary: inpatient or outpatient
Patient Chart Review Data: Current Psychiatric Medication Trials	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Patient Chart Review Data: Tobacco use history	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Binary (yes/no)
Patient Chart Review Data: Prior response to ECT or TMS	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Categorical
Patient Chart Review Data: Past Suicide Attempts	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Patient Chart Review Data: Psychiatric Review of Systems	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Descriptive, categorical
Patient Chart Review Data: Past non-psychiatric medication trials	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Number
Generating ROC curves: stress	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Clinically determined stress level (mood) will be compared to meta-feature extractions of stressed vs. not stressed from voice recordings will be used to calculate an area under the receiver operating curve (AUOC)
Generating ROC curves: fatigue	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Clinically determined fatigue (motor) will be compared to meta-feature extractions of fatigued vs. awake from voice recordings will be used to calculate an area under the receiver operating curve (AUOC)
Generating ROC curves: sentiment	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Clinically determined sentiment (affect and mood) will be compared to meta-feature extractions of happy vs. sad from voice recordings will be used to calculate an area under the receiver operating curve (AUOC)
Patient Chart Review Data: Tobacco use pack year	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	pack-year (total years smoked\*average packs per day)
Patient Chart Review Data: Prior transcranial magnetic stimulation (TMS) treatment	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	Binary (yes/no)
Patient Chart Review Data against voice features	Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.	We will evaluate voice features with statistically significant changes against respective participant chart review data using a general linear model with a clustering component for repeated measures which may also be applied to contrast statements evaluating overall change over time (from baseline to end).

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States