Content-free Speech Analysis for Measurement of Mental Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mental Disorder, Conditions Influencing Health Status

Intervention / Treatment
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* Diagnostic Test: Speech analysis tool
* Diagnostic Test: Conventional psychological measurements


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with mental illness<br>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<br>* 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.<br>Diagnostic Test: Conventional psychological measurements<br>* Using well known and validated psychological measurements to identify the mental state of the participants.<br>|
| Other: Participants without any mental illness<br>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<br>* 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.<br>Diagnostic Test: Conventional psychological measurements<br>* Using well known and validated psychological measurements to identify the mental state of the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Disorder, Treatment planning, Technical measurements of mental state, Course-prediction of Mental Illness