Back to resultsContent-free Speech Analysis for Measurement of Mental Health
Primary Purpose
Mental Disorder, Conditions Influencing Health Status
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Speech analysis tool
Conventional psychological measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Mental Disorder focused on measuring Mental Disorder, Treatment planning, Technical measurements of mental state, Course-prediction of 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.
Sites / Locations
- Neuropsychiatric Center of Hamburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Participants with mental illness
Participants without any mental illness
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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)
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.
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.
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.
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.
Full Information
NCT ID
NCT03700008
First Posted
October 4, 2018
Last Updated
August 19, 2021
Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Collaborators
VoiceSense Ltd. Herzelba, Israel
1. Study Identification
Unique Protocol Identification Number
NCT03700008
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Collaborators
VoiceSense Ltd. Herzelba, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Conditions Influencing Health Status
Keywords
Mental Disorder, Treatment planning, Technical measurements of mental state, Course-prediction of Mental Illness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with mental illness
Arm Type
Other
Arm Description
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.
Arm Title
Participants without any mental illness
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Speech analysis tool
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Conventional psychological measurements
Intervention Description
Using well known and validated psychological measurements to identify the mental state of the participants.
Primary Outcome Measure Information:
Title
Global scores of Symptom-Checklist 90 (SCL-90)
Description
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.
Time Frame
score at the date of start of participation (day 1)
Secondary Outcome Measure Information:
Title
Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9)
Description
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
Time Frame
score at the date of start of participation (day 1)
Title
Global score of anxiety, measured with the "Generalized Anxiety Disorder 7" GAD-7
Description
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)
Time Frame
score at the date of start of participation (day 1)
Title
Personality disorders and states, measured with the Big five personality test (B5T)
Description
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.
Time Frame
score at the date of start of participation (day 1)
Title
Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS)
Description
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.
Time Frame
score at the date of start of participation ("day 1")
Title
Changes of global scores of Symptom-Checklist 90 (SCL-90)
Description
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.
Time Frame
scores an average 5 weeks after day 1 and changes compared to scores at day 1
Title
Changes of global scores of Symptom-Checklist 90 (SCL-90)
Description
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.
Time Frame
scores at an average 10 weeks after day 1 and changes compared to scores at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Tonn, MD
Organizational Affiliation
Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuropsychiatric Center of Hamburg
City
Hamburg
ZIP/Postal Code
22769
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36040767
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.
Results Reference
derived
PubMed Identifier
32406862
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.
Results Reference
derived
Learn more about this trial
Content-free Speech Analysis for Measurement of Mental Health
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