Content-free Speech Analysis for Measurement of Mental Health

Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700008
• Other study ID #: TONN_2018_01
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2021
• Source: Neuropsychiatrischen Zentrums Hamburg-Altona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 30, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conditions Influencing Health Status
• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	Neuropsychiatric Center of Hamburg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Neuropsychiatrischen Zentrums Hamburg-Altona	VoiceSense Ltd. Herzelba, Israel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global scores of Symptom-Checklist 90 (SCL-90)	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	Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9)	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)
Secondary	Global score of anxiety, measured with the "Generalized Anxiety Disorder 7" GAD-7	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)
Secondary	Personality disorders and states, measured with the Big five personality test (B5T)	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)
Secondary	Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS)	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")
Secondary	Changes of global scores of Symptom-Checklist 90 (SCL-90)	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
Secondary	Changes of global scores of Symptom-Checklist 90 (SCL-90)	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