NCT06860165招募中不适用
Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients With Unipolar Depression: An Observational Study Against Standard Depression Assessment Questionnaires
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Emobot
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Change of score EmoDTx
研究概览
简要总结
The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care.
Participants who agree to take part in the study, during a selection visit, will be able to:
- Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 8-week follow-up period.
- Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own.
- At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment.
- The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks.
- In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of score EmoDTx
时间窗: From baseline to 4 weeks
Absolute difference
Change of score MADRS administrated by an investigator
时间窗: From baseline to 4 weeks
Absolute difference
次要结局
- Change of EmoDTx score(between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks)
- Change of score PHQ-9 self reported(Between 2 weeks and 6 weeks)
- Change of HAMD-17 questionnaire administered by the investigator(Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks)
- Change of score QIDS- SR16 self administrated(between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks)
- Change of score BDI-II self administrated(between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks)
- Score EmoDTx(At 4-weeks, at 8 week)
- Score MADRS administrated by the investigator(At 4-weeks, at 8 week)
- Score HAMD-17 administrated by the investigator(At 4-weeks, at 8 week)
- Score PHQ-9 self administrated(At 2-weeks and 6 weeks.)
- Score QIDS-SR16 self administrated(At 4-weeks and 8 weeks)
- To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires HAMD-17, within 4 weeks and 8 weeks of follow-up.(Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires HAMD-17 Changes in depression severity)
- To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires MADRS, within 4 weeks and 8 weeks of follow-up.(Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires MADRS Changes in depression severity)
- Score EQ-5D-5L(At 4 weeks and 8 weeks)
- Change of EmoDTx score when feedback is deactivated(From baseline to 4 weeks)
- Change of EmoDTx score when feedback is activated(From 4 weeks to 8 weeks)
- Acceptability of medical device questionnaire(A baseline and 8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Developing and Validating Digital Affective Patient Experience/Outcome MeasurePregnancy RelatedValidation StudiesReaction AffectiveNCT03337321Helsinki University Central Hospital1,000
招募中
不适用
Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive EpisodeMajor Depressive Disorder (MDD)NCT06601140Emobot104
已完成
不适用
Emotion Tracking Study for ResidentsStress, EmotionalNCT02947477University of California, San Francisco100
已完成
不适用
MOST EMPOWER: Optimizing An Emotion Regulation InterventionCancerNCT04317417Wake Forest University Health Sciences352
尚未招募
不适用
METRIKAMIND - Development of a Digital Mental Health Ecosystem for Workplace EnvironmentsDepression DisordersAnxietyNCT06650176David Gallardo-Pujol400