Mobile Observation Of Depression

Major Depressive Disorder Clinical Trial

— MOOD  

Official title:

Mobile Observation Of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815459
• Other study ID #: MOOD
• Status: Completed
• Start date: July 15, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: Emteq Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.

Description:

Assessment of participants living with a DSM5 research diagnosis of Bipolar disorder or Major depressive disorder as well as healthy controls who will be recruited and characterised through precision phenotyping involving cross-sectional assessment of biobehavioural and physiological markers of the symptoms of depression. Correlations between objective (i.e., OCOsense glasses captured) and subjective (i.e., self-reported) symptoms of depression will be measured within as well as across diagnoses. The resulting biobehavioral clusters will form the building block of a digital phenotyping tool based upon the wider spectrum of non-verbal behaviours and physiology defined and affected by the phenotype of depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

All participants:

• Ability to read & understand English. This is because the majority of our questionnaires are validated in the English language only.
• Able to walk, sit, lay and stand unaided Clinical cases: ? = 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression) Exclusion Criteria:

Healthy control participants:

• Self-reported current or past history (suspected or diagnosed) of any psychiatric condition
• <5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)
• <5 on the PhQ-9 (no depression)
• Receiving medication for any psychiatric disorder (excluding fibromyalgia)

All participants:

• < 18 years of age or >40 years of age
• Anatomical constraints that affect fit (e.g. facial disfigurement)
• Facial nerve damage which limits the ability to make facial expressions
• Body Mass Index (BMI) >29.9 which we deem may affect physical mobility

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Major Depressive Episode

Intervention

Device:
• OCOsense
Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks

Locations

Country	Name	City	State
United Kingdom	Emteq Labs	Brighton	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Emteq Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure	Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By comparing the ratio of corrugator to zygomatic muscle activation, the OCOsense glasses will produce: - Objective valence at a given time (ratio/intensity of corrugator to zygomatic muscle activation at that time).	4 hours
Primary	The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure	Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By measuring corrugator and zygomatic muscle activation, the OCOsense glasses will produce: - Objective mood during negatively valenced exposures, neutrally valenced exposures and positively valenced exposures described in terms of expression intensity and variability for each exposure.	4 hours
Primary	Identifying physical activity engagement.	The OCOsense glasses contain Inertial Measurement Units (IMU) sensors. By detecting inertial displacement over time OCOsense will detect: - Movement: a measure of movement over a period of time - specifically, how much of the time period is spent (i) stationary, (ii) in motion, (iii) fidgeting, (iv) engaging with a variety of activities of daily living	2 hours
Secondary	Investigating the relationship between vocal prosody and self-reported subjective mood	The OCOsense glasses contain a microphone. By detecting vocal parameters over time OCOsense will detect: - the nonsemantic lexical features of speech related to pitch and tone whilst participants verbally recall a positive event in their life or engage with a semi-structured diagnostic interview.	2 hours