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Real-time assessment comparing mood changes and machine learning in adults with mild-moderate depression and a group of healthy volunteers

Real-time assessment comparing mood changes and machine learning in adults with mild-moderate depression and a group of healthy volunteers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000803897
Enrollment
32
Registered
2021-06-25
Start date
2021-11-01
Completion date
2025-11-01
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Depression is the most prevalent mental health disorder in New Zealand (Wells et al., 2006) and is the second leading cause of disability in the world (Ferrari et al., 2013). However, despite the availability of effective treatments for depression, less than 10% of individuals with depression in many countries receive treatment in a timely way (Reddy, 2010). There are several barriers to early diagnosis and treatment including, limited access to mental health services and a lack of objective assessment techniques based on behavioural or physiological parameters which taken together, result in delayed presentations and poorer outcomes. Therefore, this study aims to acquire, in a pilot clinical population, physiological and behavioural data through the application of inbuilt sensors in smartphones and smartwatches and develop a machine-learning algorithm (moodAI) that will help in the earlier detection of depression and also provide a relapse signature on an individual level.

Interventions

Intervention - All participants with depression will be provided study-specific smartphones and smartwatches at the start of the study (once off) that will passively acquire physiological and behavioural data through the built-in sensors in these smartdevices. Participants would not have otherwise been given these devices in the absence of the study. Materials - Each participant will be provided with a commercially available smartphone (OneNord) based on the Android platform and a commercially

Intervention - All participants with depression will be provided study-specific smartphones and smartwatches at the start of the study (once off) that will passively acquire physiological and behavioural data through the built-in sensors in these smartdevices. Participants would not have otherwise been given these devices in the absence of the study. Materials - Each participant will be provided with a commercially available smartphone (OneNord) based on the Android platform and a commercially available wearable smartwatch/fitness tracker manufactured by Fitbit. Data captured - Physiological data captured passively includes breathing/heart rates, heart rate variability, sleep quality, and step activity. Behavioural data includes the acoustic features of speech when participants complete daily 2-5 minute audio diaries. Procedures - Participants will complete an initial screening in person to assess for suitability to participate in this study. If considered suitable, there will be a demonstration of how to use the devices (both smartwatch and smartphone). They will then be provided with the smartdevices and a SIM card for the study-supplied smartphone. They will also be provided with the Fitbit smartwatch to wear during sleep and for most of the day. Fitbit smartwatches will potentially capture physiological data continuously and passively (as long as the participant is wearing it) - given the potential confounder of movement artefacts during the day, overnight measurements will be of particular interest. The smartphones will be used to capture interactive data - these include daily audio diaries (once a day) and ecological momentary assessments (up to five times daily). Participants are expected to record short audio diaries (2-5 mins in length) once a day on their smartphone. Tasks they would have to complete as part of the audio diaries include describing their day in general and then specific questions on bad aspects of the day and good aspects of the day respectively. These tasks will capture unstructured speech rather than structured speech (e.g. reading a stock sentence out loud daily). Ecological momentary assessments (EMAs) will be captured up to 5 times a day and will take less than a minute each to complete. EMAs will be on a Likert scale which the participant can select indicating how they are feeling at the time of completing the EMA. Who will provide the smartdevices - Clinical screening will be undertaken by the clinicians in the team with mental health expertise while the demonstration of how to use the smartdevices and support during the study will be provided by team members with a computer and software engineering background. Mode of delivery - Smartdevices will be provided to individual participants face to face and will be collected from participants at the end of the study. Location of intervention - Participants will come in for a face to face initial clinical screening assessment at the start of the study at the Clinical Research Centre of the University of Auckland which is in an urban centre. If considered suitable to participate, they will be provided with the smartdevices which they will have with them for a period of 1 month of data collection. The 1 month of data collection will be in the participants' own environment e.g. home, workplace, gym, etc. as they will be carrying these smartdevices with them. Refer to the Procedures section for details of the data captured. Adherence - Participants will be individually contacted weekly into the study after they are recruited to check whether they are able to use the smartdevices confidently and troubleshoot should they be encountering any technical challenges. Study duration - Total of 1 year. Data from individual participants will be gathered over a period of 1 month.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for participants with depression - • Participant is willing and able to give informed consent for participation in the study • Male or female, aged 18 years or above and less than 60 years • Able and willing to comply with all study requirements as assessed by the research team • Following a referral from their GP, diagnostic confirmation of major depressive disorder for at least two weeks will be undertaken by the research team. Participants will be assessed using the Mini-International Neuropsychiatric Interview (MINI) which is a structured diagnostic clinical interview using DSM V criteria (American Psychiatric Association, 2013; Sheehan et al., 1998) and a Montgomery-Asberg Depression Rating Scale (MADRS) score 7-19 inclusive for mild depression and 20-34 inclusive for those with moderate depression (Williams & Kobak, 2008) Inclusion criteria for healthy controls - • Participant is willing and able to give informed consent for participation in the study • Male or female, aged 18 years or above and less than 60 years • As assessed by the research team, to be able and willing to comply with all study requirements • Participants will be assessed using the Mini-International Neuropsychiatric Interview (MINI) which is a structured diagnostic clinical interview using DSM V criteria (American Psychiatric Association, 2013; Sheehan et al., 1998) and Montgomery-Asberg Depression Rating Scale (MADRS) score of 6 or less for self-referrals (Williams & Kobak, 2008). Absence of major depressive disorder will be necessary for at least three months.

Exclusion criteria

Exclusion criteria for participants with depression - • History of psychosis or personality disorder • Any unstable medical or neurological condition • Substance abuse or dependence in the last six months • Planned major changes to psychotropic medication • Imminent risk of suicide as determined by the Columbia-Suicide Severity Rating Scale (CSSRS) (Posner et al., 2011) • Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the study • Inability to speak or read English to a level that enables informed consent and/or participation in the study • Those who are unable or disinterested in using the technology involved in the study Exclusion criteria for healthy participants (controls) - • Prior history of any physical health or mental health diagnosis

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026