NCT06793176

Brief Summary

Vibraimage technology captures high-frame-rate images of head-neck movements, converting them into vibraimages that display muscle vibration amplitude and frequency. Using algorithms and calculations, it derives an emotional index from these images. This non-contact, objective method analyzes psychological indicators through micro-movement detection. An algorithm has been developed to detect depression by calculating 12 emotional and 2 psychophysiological parameters. This diagnostic accuracy study aims to validate the technology's ability to diagnose depression in psychiatric outpatients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 26, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

January 20, 2025

Last Update Submit

March 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • discrimination

    The primary outcome measure is the diagnostic discrimination of Vibraimage technology for depression, assessed by calculating the area under the receiver operating characteristic (ROC) curve. Participants first undergo video capture, followed by a clinical diagnosis of depression by a physician. Both the physician and participants are blinded to the results of the video analysis.

    Participants undergo video capture and same-day clinical diagnosis by a physician. Video analysis and suggestive diagnosis are completed on the following day.

Study Arms (2)

Depressed Group

This group consists of individuals who were ultimately diagnosed with depression by a specialist physician.

Diagnostic Test: Video capture

Non-Depressed Group

This group consists of individuals who were ultimately diagnosed as not having depression by a specialist physician.

Diagnostic Test: Video capture

Interventions

Video captureDIAGNOSTIC_TEST

A 20-second video capture of head-neck movements at high frame rates is conducted for all participants to obtain high-resolution images. The captured videos are analyzed using an algorithm based on Vibraimage technology to infer whether the participants have depression.

Depressed GroupNon-Depressed Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Psychiatric outpatients attending the Beijing Huilongguan Hospital during the study period.

You may qualify if:

  • Aged 18 to 70 years.
  • No difficulties in reading or writing Chinese; fluent in Mandarin.
  • Currently not taking psychotropic medications or on a stable dose for at least 6 weeks.
  • Provided informed consent to participate in the study.

You may not qualify if:

  • Schizophrenia.
  • Bipolar disorder.
  • History of organic brain disease or significant head trauma.
  • Presence of severe systemic medical conditions.
  • Suicidal ideation or a score ≥3 on Item 3 ("Suicide") of the 17-item Hamilton Depression Rating Scale (HAMD-17).
  • Substance dependence or abuse.
  • Intellectual disability or dementia.
  • Inability to complete video capture or cooperate due to uncontrollable factors (e.g., hyperactivity, Parkinson's disease, or other conditions that prevent remaining still)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, 100096, China

Location

Related Publications (1)

  • Jiang B, Zhang Y, Xie Z, Wu Z, Ma Y, Zhang X, Feng Y. A novel non-contact screening tool based on Vibraimage technology for detecting depressive disorder in psychiatric outpatients: A diagnostic accuracy study. J Affect Disord. 2026 Jan 1;392:120232. doi: 10.1016/j.jad.2025.120232. Epub 2025 Sep 2.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

January 26, 2025

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be made available to qualified researchers upon reasonable request. Data sharing will be subject to approval by the principal investigator (PI) and the study sponsor.

Locations