Clinical trial NCT05815459: Mobile Observation Of Depression
Official title: Mobile Observation Of Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Major Depressive Episode
Bipolar Disorder
Keywords: Digital phenotyping
Emotion
OCOSense
Wearables
Multimodal
Lead sponsor: Emteq Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sampling of young adults.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure
timeFrame: 4 hours
measure: The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure
timeFrame: 4 hours
measure: Identifying physical activity engagement.
timeFrame: 2 hours
Secondary outcomes:
measure: Investigating the relationship between vocal prosody and self-reported subjective mood
timeFrame: 2 hours
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Emteq Labs
state: East Sussex
Study officials:
affiliation: Emteq CSO
name: Charles Nduka, MA, MD, FRCS
role: STUDY_DIRECTOR
References: