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Content-free Speech Analysis for Measurement of Mental Health

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ClinicalTrials.gov Identifier: NCT03700008
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
VoiceSense Ltd. Herzelba, Israel
Information provided by (Responsible Party):
Neuropsychiatrischen Zentrums Hamburg-Altona

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.

Condition or disease Intervention/treatment Phase
Mental Disorder Conditions Influencing Health Status Diagnostic Test: Speech analysis tool Diagnostic Test: Conventional psychological measurements Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
Masking: Single (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.
Primary Purpose: Diagnostic
Official Title: Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Participants with mental illness

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
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.

Diagnostic Test: Conventional psychological measurements
Using well known and validated psychological measurements to identify the mental state of the participants.

Participants without any mental illness
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
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.

Diagnostic Test: Conventional psychological measurements
Using well known and validated psychological measurements to identify the mental state of the participants.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9) [ Time Frame: score at the date of start of participation (day 1) ]
    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

  2. 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) ]
    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)

  3. Personality disorders and states, measured with the Big five personality test (B5T) [ Time Frame: score at the date of start of participation (day 1) ]
    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.

  4. Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS) [ Time Frame: score at the date of start of participation ("day 1") ]
    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.

  5. 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 ]
    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. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700008


Contacts
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Contact: Peter Tonn, MD +494053307380 tonn@npz-hamburg.de

Locations
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Germany
Neuropsychiatric Center of Hamburg Recruiting
Hamburg, Germany, 22769
Contact: Nina Schulze, MoS    +494053307380    schulze@npz-hamburg.de   
Sponsors and Collaborators
Neuropsychiatrischen Zentrums Hamburg-Altona
VoiceSense Ltd. Herzelba, Israel
Investigators
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Principal Investigator: Peter Tonn, MD Director

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Responsible Party: Neuropsychiatrischen Zentrums Hamburg-Altona
ClinicalTrials.gov Identifier: NCT03700008     History of Changes
Other Study ID Numbers: TONN_2018_01
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neuropsychiatrischen Zentrums Hamburg-Altona:
Mental Disorder
Treatment planning
Technical measurements of mental state
Course-prediction of Mental Illness

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders