ACES: Ascertaining Diagnosis Classification With Elicited Speech

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT05601063
Collaborator
Winterlight Labs (Industry)
255
1
23
11.1

Study Details

Study Description

Brief Summary

Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.

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 Design

Study Type:
Observational
Actual Enrollment :
255 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Ascertaining Diagnosis Classification With Elicited Speech
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Speech features from the Winterlight Speech Assessment [Baseline]

    Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment

Secondary Outcome Measures

  1. Brief Symptom Inventory [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

  2. Patient Health Questionnaire - 9 [Baseline]

    9 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.

  3. Generalized Anxiety Disorder - 7 [Baseline]

    7 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.

  4. Prodromal Questionnaire - Brief [Baseline]

    18 item. Range = 0, no - 1, yes. Higher scores resulting in worse outcome.

  5. Scale for the Assessment of Thought Language and Communication [Baseline]

    20 item, range= 0, absent - 3, severe; higher scores resulting in worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zucker Hillside Hospital Glen Oaks New York United States 11004

Sponsors and Collaborators

  • Northwell Health
  • Winterlight Labs

Investigators

  • Principal Investigator: Sunny X Tang, MD, Northwell Health, The Feinstein Institutes of Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunny Tang, Assistant Professor, Northwell Health
ClinicalTrials.gov Identifier:
NCT05601063
Other Study ID Numbers:
  • 20-0468
First Posted:
Nov 1, 2022
Last Update Posted:
Nov 1, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunny Tang, Assistant Professor, Northwell Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2022