Mobile Observation Of Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Observation Of Depression

Conditions
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Major Depressive Disorder, Major Depressive Episode, Bipolar Disorder

Intervention / Treatment
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* Device: OCOsense


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Cases<br>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. | Device: OCOsense<br>* Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks<br>|
| Control Cases<br>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. | Device: OCOsense<br>* Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotion, Digital phenotyping, OCOSense, Wearables, Multimodal