Content-free Speech Analysis for Measurement of Mental Health

August 19, 2021 updated by: Neuropsychiatrischen Zentrums Hamburg-Altona

Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

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

  • Germany
      • Hamburg, Germany, 22769
        • Neuropsychiatric Center of Hamburg

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: 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.
Diagnostic test: Conventional psychological measurements
Using well known and validated psychological measurements to identify the mental state of the participants.
Other: 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.
Diagnostic test: 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.
Diagnostic test: Conventional psychological measurements
Using well known and validated psychological measurements to identify the mental state of the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global scores of Symptom-Checklist 90 (SCL-90)
Time Frame: score at the date of start of participation (day 1)
The SCL-90 evaluates the psychological distress during the past seven days using nine scales for primary symptom dimensions and three scores among global distress indices. The basic psychological distress is determined by the GSI (Global Severity Index), the intensity of the responses by the PSDI (Positive Symptom Distress Index) and by the PST (Positive Symptom Total). The global scales provide an overview of the severity of the psychological distress. The scores ranged from 0.0 to 2.9 (GSI), 0-90 (PSI) and 0.0-2.9 (PSDI), all were calculated in T-values, so no cut-off but reliable T-values are published.
score at the date of start of participation (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9)
Time Frame: score at the date of start of participation (day 1)
The PHQ-9 is a diagnostic tool, extracted from the PRIME-MD of Spitzer et al., used in DSM-5-diagnostic criteria for defining major depressive disorder. There is a Range from 9 to 36, the cut off for diagnosis of depressive disorder is 15
score at the date of start of participation (day 1)
Global score of anxiety, measured with the "Generalized Anxiety Disorder 7" GAD-7
Time Frame: score at the date of start of participation (day 1)
The GAD-7 is a diagnostic tool, extracted from the PRIME-MD of Spitzer et al., used in many studies and clinical practice to identify anxiety disorders. There is a Range from 7 to 21, the cut off for diagnosis of anxiety disorder is 9 (cutoff score 10-> sensitivity 89%, specificity 82%, test-retest reliability with ICC=0.83)
score at the date of start of participation (day 1)
Personality disorders and states, measured with the Big five personality test (B5T)
Time Frame: score at the date of start of participation (day 1)
The B5T is a diagnostic tool to measure the impact of personality traits extraversion, consciousness, neuroticism, openess, agreeableness and three special motivational scales. There are 72 items, the overall-consistency is good, the test is evaluated in a german population sample with N= 7400.
score at the date of start of participation (day 1)
Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS)
Time Frame: score at the date of start of participation ("day 1")
The ADHD-VAS is a compressed form to ask the three core-parameters of ADHD in participants with diagnosed adult ADHD, hyperactivity, impulsivity/emotional stability and inattention. There are three visual scores, ranges from 0 to 10 each, cut-off is 4 each.
score at the date of start of participation ("day 1")
Changes of global scores of Symptom-Checklist 90 (SCL-90)
Time Frame: scores an average 5 weeks after day 1 and changes compared to scores at day 1
The SCL-90 evaluates the psychological distress during the past seven days using nine scales for primary symptom dimensions and three scores among global distress indices. The basic psychological distress is determined by the GSI (Global Severity Index), the intensity of the responses by the PSDI (Positive Symptom Distress Index) and by the PST (Positive Symptom Total). The global scales provide an overview of the severity of the psychological distress. The scores ranged from 0.0 to 2.9 (GSI), 0-90 (PSI) and 0.0-2.9 (PSDI), all were calculated in T-values, so no cut-off but reliable T-values are published.
scores an average 5 weeks after day 1 and changes compared to scores at day 1
Changes of global scores of Symptom-Checklist 90 (SCL-90)
Time Frame: scores at an average 10 weeks after day 1 and changes compared to scores at day 1
The SCL-90 evaluates the psychological distress during the past seven days using nine scales for primary symptom dimensions and three scores among global distress indices. The basic psychological distress is determined by the GSI (Global Severity Index), the intensity of the responses by the PSDI (Positive Symptom Distress Index) and by the PST (Positive Symptom Total). The global scales provide an overview of the severity of the psychological distress. The scores ranged from 0.0 to 2.9 (GSI), 0-90 (PSI) and 0.0-2.9 (PSDI), all were calculated in T-values, so no cut-off but reliable T-values are published.
scores at an average 10 weeks after day 1 and changes compared to scores at day 1

Collaborators and Investigators

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

Sponsor

Neuropsychiatrischen Zentrums Hamburg-Altona

Collaborators

VoiceSense Ltd. Herzelba, Israel

Investigators

  • Principal Investigator: Peter Tonn, MD, Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 15, 2018

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TONN_2018_01

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 Mental Disorder

Clinical Trials on Speech analysis tool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe