Mental DisorderNCT03700008
Content-free Speech Analysis for Measurement of Mental Health
A study testing Speech analysis tool and Conventional psychological measurements in people with Mental Disorder and Conditions Influencing Health Status, run by Neuropsychiatrischen Zentrums Hamburg-Altona at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Conditions Influencing Health Status
- What is being tested?
- Speech analysis tool and Conventional psychological measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders
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.
Read the 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.
- Being tested
- Speech analysis tool, Conventional psychological measurements
- Keywords
- Mental Disorder, Treatment planning, Technical measurements of mental state, Course-prediction of Mental Illness
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech analysis toolDiagnostic 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.
Conventional psychological measurementsDiagnostic test
Using well known and validated psychological measurements to identify the mental state of the participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Speech analysis tool; Diagnostic Test: 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. Receives: Diagnostic Test: Speech analysis tool; Diagnostic Test: Conventional psychological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: score at the date of start of participation (day 1)
Secondary outcomes (6)
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: scores at an average 10 weeks after day 1 and changes compared to scores at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Oct 2018
- Primary completion31 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatrischen Zentrums Hamburg-Altona
- Sponsor type
- University, hospital or other
- Collaborators
- VoiceSense Ltd. Herzelba, Israel
- Responsible party
- Sponsor
- Investigators
- Peter Tonn, MD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700008
- Sponsor's protocol ID
- TONN_2018_01
- Status last verified
- Aug 2021
- First submitted
- 4 Oct 2018
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36040767Tonn 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.
PubMed 32406862
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders
- ClinicalTrials.gov ID
- NCT03700008
- Acronym / sponsor ID
- TONN_2018_01
- Keywords
- Mental Disorder, Treatment planning, Technical measurements of mental state, Course-prediction of Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Neuropsychiatrischen Zentrums Hamburg-AltonaUniversity, hospital or other
- Collaborators
- VoiceSense Ltd. Herzelba, Israel
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
| Arm | Type | Receives |
|---|---|---|
| Participants with mental illness | Other | Diagnostic Test: Speech analysis tool, Diagnostic Test: Conventional psychological measurementsParticipant 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 | Diagnostic Test: Speech analysis tool, Diagnostic Test: Conventional psychological measurementsParticipant 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech analysis toolUsing 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. | Diagnostic test | Participants with mental illness, Participants without any mental illness |
| Conventional psychological measurementsUsing well known and validated psychological measurements to identify the mental state of the participants. | Diagnostic test | Participants with mental illness, Participants without any mental illness |
Primary outcome
Global scores of Symptom-Checklist 90 (SCL-90)
Time frame: score at the date of start of participation (day 1)
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.
6 secondary outcomes
Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9)
Time frame: score at the date of start of participation (day 1)
Global score of anxiety, measured with the "Generalized Anxiety Disorder 7" GAD-7
Time frame: score at the date of start of participation (day 1)
Personality disorders and states, measured with the Big five personality test (B5T)
Time frame: score at the date of start of participation (day 1)
Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS)
Time frame: score at the date of start of participation ("day 1")
Changes of global scores of Symptom-Checklist 90 (SCL-90)
Time frame: 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)
Time frame: scores at an average 10 weeks after day 1 and changes compared to scores at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Derived from this study: PubMed 36040767Tonn 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.
- Derived from this study: PubMed 32406862Tonn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Tonn, MD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech analysis tool and Conventional psychological measurements in people with Mental Disorder and Conditions Influencing Health Status, run by Neuropsychiatrischen Zentrums Hamburg-Altona at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global scores of Symptom-Checklist 90 (SCL-90) (time frame: score at the date of start of participation (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.