Mobile Observation Of Depression

Completed

• Conditions: Major Depressive Disorder; Major Depressive Episode; Bipolar Disorder
• Interventions: Device: OCOsense

• Registration Number: NCT05815459
• Lead Sponsor: Emteq Ltd

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-15
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical Cases	OCOsense	Participants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities.
Control Cases	OCOsense	Participants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities.

Primary Outcome Measures

Name	Time	Method
The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure	4 hours	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).
The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure	4 hours	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.
Identifying physical activity engagement.	2 hours	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

Secondary Outcome Measures

Name	Time	Method
Investigating the relationship between vocal prosody and self-reported subjective mood	2 hours	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.

Trial Locations

Locations (1)

Emteq Labs; 🇬🇧 Brighton, East Sussex, United Kingdom