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NCT Number: NCT03700008

Content-free Speech Analysis for Measurement of Mental Health

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.

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Key information

Conditions

Mental Disorder Conditions Influencing Health Status Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuropsychiatric Center of Hamburg

Hamburg, 22769, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Conventional psychological measurements

Diagnostic Test

Using well known and validated psychological measurements to identify the mental state of the participants.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Neuropsychiatrischen Zentrums Hamburg-Altona

Other

Collaborators

  • VoiceSense Ltd. Herzelba, Israel

Registry information

Official study title

Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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