Content-free Speech Analysis for Measurement of Mental Health

NCT ID: NCT03700008

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2020-12-30

Brief Summary

Trial to prove the functionality and efficacy of a content-free speech analysis tool to detect problematic mental health status or phases of patients with pre known or unknown mental health disorders, focussed on affective disorders or neurodevelopmental disorders. The participants talk in free speech to the tool, this will be analyzed content-free and compared with psychological instruments to detect the mental status in conventional way.

Detailed Description

Participants with and without pre known mental disorders will be recruited and analyzed with speech analysis and conventional psychological instruments, as primary measurement the SCL-90-Scale, as secondary instruments the PRIME-MD (explicit in use the PHQ-9 for depressive symptoms and the GAD-7 for anxiety), B5T and an ADHD-VAS-Score (t0). Then the investigators check the status of the participants later at t1 (4-6 weeks after t0) and t2 (4-6 weeks after t1).

The speech measuring instruments is the "VoiceSense" digital voice analysis tool, which enables the analysis of 200 specific speech parameters and the assessment of the findings through the use of psychometric instruments and questionnaires.

The hypothesis is that the data of the voicesense analysis tool compared to the psychological instruments provide a good match and the voicesense technique can be used as a predictive and course-description tool in mental illness.

Conditions

Mental Disorder; Conditions Influencing Health Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Participants with mental illness

Participant with pre known or actually diagnosed mental disorder, especially affective or neurodevelopmental disorder.

Using the speech analysis tool with 120 seconds of free speech, measure the mental state with SCL-90, PRIME-MD, B5T, ADHD-VAS as conventional psychological measurements.

Group Type: OTHER

Speech analysis tool

Intervention Type: DIAGNOSTIC_TEST

Using the speech analysis tool with recording 120 seconds of free speech and analysis of 200 content-free parameters of the speech including factor analytic process to compress the data to 5-10 core parameters.

Conventional psychological measurements

Intervention Type: DIAGNOSTIC_TEST

Using well known and validated psychological measurements to identify the mental state of the participants.

Participants without any mental illness

Participant with never diagnosed mental disorder, in a healthy mental state. Using the speech analysis tool with 120 seconds of free speech, measure the mental state with SCL-90, PRIME-MD, B5T, ADHD-VAS as conventional psychological measurements.

Group Type: OTHER

Speech analysis tool

Intervention Type: DIAGNOSTIC_TEST

Using the speech analysis tool with recording 120 seconds of free speech and analysis of 200 content-free parameters of the speech including factor analytic process to compress the data to 5-10 core parameters.

Conventional psychological measurements

Intervention Type: DIAGNOSTIC_TEST

Using well known and validated psychological measurements to identify the mental state of the participants.

Interventions

Speech analysis tool

Using the speech analysis tool with recording 120 seconds of free speech and analysis of 200 content-free parameters of the speech including factor analytic process to compress the data to 5-10 core parameters.

Intervention Type: DIAGNOSTIC_TEST

Conventional psychological measurements

Using well known and validated psychological measurements to identify the mental state of the participants.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• being regular outpatient with mental disorder (verum group)
• being voluntary participant without mental disorder (control group)
• native german language speakers
• in good general health (absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis)

Exclusion Criteria

• schizophrenia
• dementia
• pregnancy or breastfeeding
• current or recent (less than 1 year) history of alcohol and/or drug abuse
• current or recent (less than 1 year) history of suicide attempts
• other significant comorbidities according to the Investigator's clinical assessment (for example, cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VoiceSense Ltd. Herzelba, Israel

UNKNOWN

Sponsor Role: collaborator

Neuropsychiatrischen Zentrums Hamburg-Altona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Tonn, MD

Role: PRINCIPAL_INVESTIGATOR

Director

Locations

Neuropsychiatric Center of Hamburg

Hamburg, , Germany

Countries

Germany

References

Tonn P, Seule L, Degani Y, Herzinger S, Klein A, Schulze N. Digital Content-Free Speech Analysis Tool to Measure Affective Distress in Mental Health: Evaluation Study. JMIR Form Res. 2022 Aug 30;6(8):e37061. doi: 10.2196/37061.

Reference Type: DERIVED

PMID: 36040767 (View on PubMed)

Tonn P, Degani Y, Hershko S, Klein A, Seule L, Schulze N. Development of a Digital Content-Free Speech Analysis Tool for the Measurement of Mental Health and Follow-Up for Mental Disorders: Protocol for a Case-Control Study. JMIR Res Protoc. 2020 May 14;9(5):e13852. doi: 10.2196/13852.

Reference Type: DERIVED

PMID: 32406862 (View on PubMed)

Other Identifiers

TONN_2018_01

Identifier Type: -

Identifier Source: org_study_id