Clinical trial NCT03700008: Content-free Speech Analysis for Measurement of Mental Health
Official title: Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Conditions Influencing Health Status
Keywords: Mental Disorder
Treatment planning
Technical measurements of mental state
Course-prediction of Mental Illness
Lead sponsor: Neuropsychiatrischen Zentrums Hamburg-Altona
Sponsor class: OTHER
Collaborators: name: VoiceSense Ltd. Herzelba, Israel
First posted: 2018-10-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Global scores of Symptom-Checklist 90 (SCL-90)
timeFrame: score at the date of start of participation (day 1)
Secondary outcomes:
measure: Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9)
timeFrame: score at the date of start of participation (day 1)
measure: Global score of anxiety, measured with the "Generalized Anxiety Disorder 7" GAD-7
timeFrame: score at the date of start of participation (day 1)
measure: Personality disorders and states, measured with the Big five personality test (B5T)
timeFrame: score at the date of start of participation (day 1)
measure: Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS)
timeFrame: score at the date of start of participation ("day 1")
measure: Changes of global scores of Symptom-Checklist 90 (SCL-90)
timeFrame: scores an average 5 weeks after day 1 and changes compared to scores at day 1
measure: Changes of global scores of Symptom-Checklist 90 (SCL-90)
timeFrame: scores at an average 10 weeks after day 1 and changes compared to scores at day 1
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Neuropsychiatric Center of Hamburg
Study officials:
affiliation: Director
name: Peter Tonn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.