Schizophrenia Spectrum and Other Psychotic DisordersACESNCT05601063
Ascertaining Diagnosis Classification With Elicited Speech
An observational study of Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar and Related Disorders, run by Northwell Health at 1 site in United States.
Trial summary
Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders. Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Depressive Disorder
- What is being tested?
- Winterlight Speech Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.
Read the 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.
- Conditions
- Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Depressive Disorder, Anxiety Disorders, Personality Disorders, Attention Deficit Hyperactivity Disorder
- Being tested
- Winterlight Speech Assessment
- Keywords
- Psychiatry, language, natural language processing, digital health
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Depressive Disorder, Anxiety Disorders, Personality Disorders, Attention Deficit Disorder with Hyperactivity, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winterlight Speech AssessmentBehavioural
Digital assessment of speech and language abilities
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Winterlight Speech Assessment | |
| Healthy controls | Healthy comparison subjects with no known psychiatric diagnosis Receives: Behavioral: Winterlight Speech Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech features from the Winterlight Speech Assessment
Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment
Measured: Baseline
Secondary outcomes (5)
Brief Symptom Inventory
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
Measured: Baseline
Patient Health Questionnaire - 9
9 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.
Measured: Baseline
Generalized Anxiety Disorder - 7
7 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.
Measured: Baseline
Prodromal Questionnaire - Brief
18 item. Range = 0, no - 1, yes. Higher scores resulting in worse outcome.
Measured: Baseline
Scale for the Assessment of Thought Language and Communication
20 item, range= 0, absent - 3, severe; higher scores resulting in worse outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Oct 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Winterlight Labs
- Responsible party
- Principal investigator, Sunny Tang, Northwell Health
- Investigators
- Sunny X Tang, MD, Principal investigator, Northwell Health, The Feinstein Institutes of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601063
- Sponsor's protocol ID
- 20-0468
- Acronym
- ACES
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascertaining Diagnosis Classification With Elicited Speech
- ClinicalTrials.gov ID
- NCT05601063
- Acronym / sponsor ID
- ACES / 20-0468
- Conditions
- Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Depressive Disorder, Anxiety Disorders, Personality Disorders, Attention Deficit Hyperactivity Disorder
- Keywords
- Psychiatry, language, natural language processing, digital health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Winterlight Labs
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychiatric patient group | – | Behavioral: Winterlight Speech AssessmentCurrent 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 controls | – | Behavioral: Winterlight Speech AssessmentHealthy comparison subjects with no known psychiatric diagnosis |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winterlight Speech AssessmentDigital assessment of speech and language abilities | Behavioural | Healthy controls, Psychiatric patient group |
Primary outcome
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
5 secondary outcomes
Brief Symptom Inventory
Time frame: Baseline
Patient Health Questionnaire - 9
Time frame: Baseline
Generalized Anxiety Disorder - 7
Time frame: Baseline
Prodromal Questionnaire - Brief
Time frame: Baseline
Scale for the Assessment of Thought Language and Communication
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunny X Tang, MD principal investigator
Northwell Health, The Feinstein Institutes of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar and Related Disorders, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech features from the Winterlight Speech Assessment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.