Mobile Observation Of Depression

NCT ID: NCT05815459

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-02-01

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.

Conditions

Major Depressive Disorder; Major Depressive Episode; Bipolar Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

OCOsense

Intervention Type: DEVICE

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.

OCOsense

Intervention Type: DEVICE

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

Interventions

OCOsense

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emteq Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Nduka, MA, MD, FRCS

Role: STUDY_DIRECTOR

Emteq CSO

Locations

Emteq Labs

Brighton, East Sussex, United Kingdom

Countries

United Kingdom

Other Identifiers

MOOD

Identifier Type: -

Identifier Source: org_study_id