Development of a Digital Content-free Speech Analysis for the Measurement of Mental Health and Follow-up of Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Global scores of Symptom-Checklist 90 (SCL-90)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •schizophrenia
- •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.
结局指标
主要结局
Global scores of Symptom-Checklist 90 (SCL-90)
时间窗: 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.
次要结局
- Global score of depression measured with the "Patients-Health-Questionnaire 9" (PHQ9)(score at the date of start of participation (day 1))
- Changes of global scores of Symptom-Checklist 90 (SCL-90)(scores at an average 10 weeks after day 1 and changes compared to scores at day 1)
- Global score of anxiety, measured with the "Generalized Anxiety Disorder 7" GAD-7(score at the date of start of participation (day 1))
- Visuel analogue scale Attention-Deficit-Hyperactivity-Disorder (ADHD-VAS)(score at the date of start of participation ("day 1"))
- Personality disorders and states, measured with the Big five personality test (B5T)(score at the date of start of participation (day 1))