- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05601063
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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
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 |
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.
|
Digital assessment of speech and language abilities
|
Healthy controls
Healthy comparison subjects with no known psychiatric diagnosis
|
Digital assessment of speech and language abilities
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
October 1, 2020
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
October 25, 2022
First Submitted That Met QC Criteria
October 29, 2022
First Posted (Actual)
November 1, 2022
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 29, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Personality Disorders
- Depressive Disorder
- Schizophrenia
- Disease
- Psychotic Disorders
- Anxiety Disorders
- Attention Deficit Disorder with Hyperactivity
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
Other Study ID 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.
Clinical Trials on Personality Disorders
-
University of Colorado, DenverCompleted
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
NHS Greater Glasgow and ClydeUnknownBorderline Personality Disorder (BPD) | Antisocial Personality Disorder (ASPD)United Kingdom
-
Icahn School of Medicine at Mount SinaiCompletedBorderline Personality Disorders | Avoidant Personality DisordersUnited States
-
University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
Universidad Nacional Autonoma de MexicoCompletedPsychopathic Personality TraitMexico
-
Silvia Elisa Hurtado SantiagoCompletedPersonality Disorder, BorderlineSpain
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingBorderline Personality Disorders | BPDSpain
-
University of RegensburgCompletedDepression | Personality Disorder, Borderline | Personality Disorder; UnstableGermany
Clinical Trials on Winterlight Speech Assessment
-
Hikma Pharmaceuticals LLCWinterlight LabsCompletedSchizophreniaAlgeria, Egypt, Jordan, Saudi Arabia
-
Assistance Publique Hopitaux De MarseilleRecruitingEpilepsy | Temporal Lobe Epilepsy | AnomiaFrance
-
Winterlight LabsActive, not recruitingPsychiatric Disorder | Language | SpeechCanada
-
Czech Technical University in PragueMayo Clinic; University Hospital, Montpellier; McGill University Health Centre... and other collaboratorsUnknownParkinson Disease | REM Sleep Behavior DisorderUnited States, Canada, Austria, Czechia, France, Germany, Italy
-
Milton S. Hershey Medical CenterBioSensicsNot yet recruitingAmyotrophic Lateral Sclerosis | Primary Lateral Sclerosis | Progressive Muscular Atrophy
-
Milton S. Hershey Medical CenterBioSensicsRecruiting
-
Samanth BurrUnknownSpeech Disorders in ChildrenUnited Kingdom
-
Massachusetts Eye and Ear InfirmaryBoston Children's Hospital; University of WashingtonRecruiting
-
Hospital de Clinicas de Porto AlegreCompletedOral Cancer | Intelligibility, Speech | Tongue Cancer | Jaw CancerBrazil
-
Radboud University Medical CenterCochlearRecruitingDeafness, Bilateral | Deafness Neurosensory | Deafness PermanentNetherlands