Ascertaining Diagnosis Classification With Elicited Speech (ACES)

October 29, 2022 updated by: Sunny Tang, Northwell Health
Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Major psychiatric disorders often occur together in the same patient and it can be difficult to distinguish between disorders with overlapping symptoms. The majority of patients with mental illness receive treatment in settings where it is not feasible to conduct detailed diagnostic interviews or neuropsychiatric testing. A cost-effective and efficient tool is needed for accurate diagnosis. Looking at language is an efficient way of making sense of the brain because it is easily observed and reflects brain circuitry. Automated natural language processing (NLP) can help us do this objectively, efficiently, and with high sensitivity. The investigators aim to use linguistic features extracted using natural language processing to aid in diagnostic classification and in predicting dimensional symptoms. This will be done by obtaining clinical diagnoses, language samples, and self-report scales from 604 participants with a variety of psychiatric symptoms. Adolescents will also be included and the investigators will try to predict diagnosis in adolescents using models that were built on adult data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker Hillside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients whose treatment team believes they would be appropriate for a research study will be approached by research staff and the research project will be explained to them in detail. Inpatients will be approached during their admission and after initial stabilization. Outpatients will be approached before or after their scheduled appointments. Educational seminars regarding this study may be held to inform clinicians and staff of our goals and protocol. Potential participants will be made aware that declining participation will not affect their care. Informed consent will be obtained from all those interested in participating in the study.

Description

Inclusion Criteria:

  • Speaks with conversational proficiency with conversational proficiency
  • Current diagnosis in the medical chart of any of the following. The patient may be in partial but not full remission. Comorbidity among these disorders and other unlisted disorders is expected and allowable.
  • Schizophrenia-spectrum disorder - schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or unspecified psychotic disorder
  • Bipolar spectrum disorder - bipolar I or II disorder, cyclothymia, unspecified or other specified bipolar disorder
  • (Unipolar) Depressive disorder - major depressive disorder, dysthymia, unspecified and other specified depressive disorder
  • Anxiety disorder - obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, post-traumatic stress disorder
  • Personality disorder - borderline personality disorder
  • Attention-Deficit Hyperactivity Disorder
  • Healthy comparison subjects
  • Age 14 - 50 years
  • Has capacity and willing to sign informed consent; if minor, parent is willing to give consent and child is willing to give assent.
  • Screening will not include a pregnancy test. Pregnant women will not be screened out of the study because the study procedures are of very low risk overall, and pregnancy does not place the participant or the fetus at any significant risk.
  • Minors will be included in the study because diagnostic ambiguity is prevalent before the age of 18 and this patient group is particularly in need of accurate prognosis and treatment. Therefore, it is of vital importance that the conclusions of the study be applicable to minors and that they be included among the participants.

Exclusion Criteria:

  • Participants with substance-induced disorders or disorders secondary to a general medical condition will not be included as underlying brain changes may be different from "primary" psychiatric disorders.
  • Disorders affecting speech or language, such as aphasia, intellectual disability (IQ<70), or language disorder, or movement disorders affecting speech like tardive dyskinesia, or physical impairments causing significant distortions to speech
  • Serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain and/or language, including but not limited to: neurodegenerative disorders, traumatic brain injury with active symptoms, autism spectrum disorder, encephalitis, epilepsy
  • Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Psychiatric patient group

Current diagnosis in the medical chart of any of the following. The patient may be in partial but not full remission. Comorbidity among these disorders and other unlisted disorders is expected and allowable.

  • Schizophrenia-spectrum disorder - schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or unspecified psychotic disorder
  • Bipolar spectrum disorder - bipolar I or II disorder, cyclothymia, unspecified or other specified bipolar disorder
  • (Unipolar) Depressive disorder - major depressive disorder, dysthymia, unspecified and other specified depressive disorder
  • Anxiety disorder - obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, post-traumatic stress disorder
  • Personality disorder - borderline personality disorder
  • Attention-Deficit Hyperactivity Disorder
Behavioral: Winterlight Speech Assessment
Digital assessment of speech and language abilities
Healthy controls
Healthy comparison subjects with no known psychiatric diagnosis
Behavioral: Winterlight Speech Assessment
Digital assessment of speech and language abilities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speech features from the Winterlight Speech Assessment
Time Frame: Baseline
Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Symptom Inventory
Time Frame: Baseline

53 item. Range = 0, not at all - 4, extremely. Higher scores resulting in worse outcome.

TLC: Scale for the Assessment of Thought Language and Communication
Baseline
Patient Health Questionnaire - 9
Time Frame: Baseline
9 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.
Baseline
Generalized Anxiety Disorder - 7
Time Frame: Baseline
7 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.
Baseline
Prodromal Questionnaire - Brief
Time Frame: Baseline
18 item. Range = 0, no - 1, yes. Higher scores resulting in worse outcome.
Baseline
Scale for the Assessment of Thought Language and Communication
Time Frame: Baseline
20 item, range= 0, absent - 3, severe; higher scores resulting in worse outcome.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwell Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Winterlight Labs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sunny X Tang, MD, Northwell Health, The Feinstein Institutes of Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-0468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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