Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| VoiceSense Ltd. Herzelba, Israel | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with mental illness | Other | 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. |
|
| Participants without any mental illness | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speech analysis tool | 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. |
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Tonn, MD | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Center of Hamburg | Hamburg | 22769 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36040767 | Derived | 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. | |
| 32406862 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
Not provided
Not provided
The outcome-assessor or rater did not know which diagnosis the participant has and the participant is informed about the diagnosis after the diagnostic procedure from a physician/ psychotherapist not involved in the study.
| Conventional psychological measurements | Diagnostic Test | Using well known and validated psychological measurements to identify the mental state of the participants. |
|
| 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 |