MOOD: Mobile Observation Of Depression

Sponsor

Emteq Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT05815459

Collaborator

(none)

Enrollment

Location

6.6

Actual Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Major Depressive Episode Bipolar Disorder	Device: OCOsense

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 Design

Study Type:

Observational

Actual Enrollment :

84 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Mobile Observation Of Depression

Actual Study Start Date :

Jul 15, 2022

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Clinical Cases 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 Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks
Control Cases 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 Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks

Arm

Intervention/Treatment

Clinical Cases

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

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

Control Cases

Device: OCOsense

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

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)