Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-06 @ 4:48 PM
Study NCT ID:
NCT05815459
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2023-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Observation Of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure', 'timeFrame': '4 hours', 'description': '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:\n\n\\- Objective valence at a given time (ratio/intensity of corrugator to zygomatic muscle activation at that time).'}, {'measure': 'The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure', 'timeFrame': '4 hours', 'description': '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:\n\n\\- Objective mood during negatively valenced exposures, neutrally valenced exposures and positively valenced exposures described in terms of expression intensity and variability for each exposure.'}, {'measure': 'Identifying physical activity engagement.', 'timeFrame': '2 hours', 'description': 'The OCOsense glasses contain Inertial Measurement Units (IMU) sensors. By detecting inertial displacement over time OCOsense will detect:\n\n\\- 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'}], 'secondaryOutcomes': [{'measure': 'Investigating the relationship between vocal prosody and self-reported subjective mood', 'timeFrame': '2 hours', 'description': 'The OCOsense glasses contain a microphone. By detecting vocal parameters over time OCOsense will detect:\n\n\\- 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital phenotyping', 'Emotion', 'OCOSense', 'Wearables', 'Multimodal'], 'conditions': ['Major Depressive Disorder', 'Major Depressive Episode', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sampling of young adults.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants:\n\n* Ability to read \\& understand English. This is because the majority of our questionnaires are validated in the English language only.\n* Able to walk, sit, lay and stand unaided\n\nClinical cases:\n\n● ≥ 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression)\n\nExclusion Criteria:\n\nHealthy control participants:\n\n* Self-reported current or past history (suspected or diagnosed) of any psychiatric condition\n* \\<5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)\n* \\<5 on the PhQ-9 (no depression)\n* Receiving medication for any psychiatric disorder (excluding fibromyalgia)\n\nAll participants:\n\n* \\< 18 years of age or \\>40 years of age\n* Anatomical constraints that affect fit (e.g. facial disfigurement)\n* Facial nerve damage which limits the ability to make facial expressions\n* Body Mass Index (BMI) \\>29.9 which we deem may affect physical mobility'}, 'identificationModule': {'nctId': 'NCT05815459', 'acronym': 'MOOD', 'briefTitle': 'Mobile Observation Of Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emteq Ltd'}, 'officialTitle': 'Mobile Observation Of Depression', 'orgStudyIdInfo': {'id': 'MOOD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical Cases', 'description': '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.', 'interventionNames': ['Device: OCOsense']}, {'label': 'Control Cases', 'description': '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.', 'interventionNames': ['Device: OCOsense']}], 'interventions': [{'name': 'OCOsense', 'type': 'DEVICE', 'description': 'Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks', 'armGroupLabels': ['Clinical Cases', 'Control Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN1 9SB', 'city': 'Brighton', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Emteq Labs', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}], 'overallOfficials': [{'name': 'Charles Nduka, MA, MD, FRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emteq CSO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Where possible, fully anonymised data will be hosted on a secure data responsibility. Specific details will be updated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emteq Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}