Voice Changes During ECT

NCT04420793 | Completed

• 1 other identifier: 00089198
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Unipolar Depression; Bipolar Depression; Bipolar Disorder, Manic

Keywords

VAPRE

Outcome Measures

Primary Outcomes (22)

• Acoustic feature: zero crossing rate

  crossings per second

  Throughout a course of electroconvulsive therapy (ECT) which may last between 2 and 7 weeks.

• Acoustic feature: energy and entropy

  decibels

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Acoustic feature: spectral centroid, spectral spread, spectral entropy, spectral flux, spectral rolloff

  hertz

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Acoustic feature: Mel-Frequency Cepstral Coefficients, Chroma Vectors, and Chroma Deviation

  unitless

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic features: question ratio, filler ratio, number ratio, type token ratio

  unitless ratio

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic features: verb frequency, noun frequency, pronoun frequency, adverb frequency, adjective frequency, particle frequency, conjunction frequency, pronoun frequency

  percentage

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic features: standardized word entropy

  decibels/log(total word count)

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic features: Brunets index

  W (lexical richness)

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic features: Honores statistic

  R (lexical richness)

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic features: rate of speech

  words per minute

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: fatigue

  Machine learning approach to evaluate binary outcome: fatigued or awake

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: audio quality

  Machine learning approach to evaluate binary outcome: bad or good

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: sentiment

  Machine learning approach to evaluate binary outcome: sad or happy

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: stress

  Machine learning approach to evaluate binary outcome: stressed or not stressed

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: gender

  Machine learning approach to evaluate binary outcome: male or female

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: accent

  Machine learning approach to evaluate a categorical outcome of accent region: england, indian, australian, etc.

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: length

  seconds

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-features: age

  Machine learning approach to evaluate estimated decade-age: 10s, 20s, 30s, 40s, 50s, 60s, 70s, 80s, 90s, etc.

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Comparing the voice feature(s) with greatest statistically significant change to Patient Health Questionnaire (PHQ)-9 scores

  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

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Acoustic Feature Specific Changes within and across sessions

  Generalized mixed linear model will be used to evaluate which acoustic features change with P value threshold of \<0.05

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic Feature Specific Changes within and across sessions

  Generalized mixed linear model will be used to evaluate which linguistic features change with P value threshold of \<0.05

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-Feature Specific Changes within and across sessions

  Generalized mixed linear model will be used to evaluate which meta features change with P value threshold of \<0.05

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

Secondary Outcomes (30)

• Acoustic Feature Specific Changes between sessions

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Linguistic Feature Specific Changes between sessions

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Meta-Feature Specific Changes between sessions

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Patient Chart Review Data: Age

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

• Patient Chart Review Data: inpatient/outpatient status

  Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.

Study Arms (1)

ECT and Voice Recorded Group

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.

Other: Questionnaire

Interventions

Questionnaire OTHER

3 voice recording tasks and 1 text entry task will be performed.

ECT and Voice Recorded Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing electroconvulsive therapy (ECT) at the Medical University of South Carolina on an outpatient or inpatient basis.

You may qualify if:

• Any candidate for electroconvulsive therapy who is about to initiate their ECT course at Medical University of South Carolina (MUSC) for a clinically indicated diagnosis
• Age 18 to 90 years old
• Able to speak and understand English
• Able to give consent to participate in the study

You may not qualify if:

• Any medical condition that limits the ability to speak or speak clearly, for example a history of head and/or neck cancer, spinal cord injury affecting speech, amyotrophic lateral sclerosis, or those with absence of critical anatomical structures involved in speech.
• Patients who are receiving ECT by involuntary order, by order of their guardian, or by a court order, as evidenced by patient report or brief chart review.
• Patients who elect to not receive their full course of ECT at MUSC.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sean Christensen, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: June 9, 2020
• Study Start: November 7, 2019
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)