Real-time assessment comparing mood changes and machine learning in adults with mild-moderate depression and a group of healthy volunteers
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12621000803897
- Lead Sponsor
- The University of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in heart-rate variability using the smartwatch. <br><br>(Heart-rate variability is reported as the root mean square of successive differences between heartbeats)[Using the smartwatch to passively capture heart physiological data on a daily basis for a period of 1 month. <br>];Change in subjective mood ratings using ecological momentary assessment (EMAs) which measure subjective mood on a 10-point Likert scale. [EMAs will be completed several times daily (up to 5 times daily) to capture mood variation over 1 month.];Change in the acoustic features of speech - the main features examined are prosody and jitter. Using the smartphone to capture the acoustic features of speech (spoken audio diaries of 2-5 minutes duration). [Speech data will be captured once daily over a period of 1 month.<br>]
- Secondary Outcome Measures
Name Time Method Change in breathing rate as measured by the smartwatch.[Breathing rate will be measured on a daily basis for a period of 1 month. Breathing rate is measured as breaths per minute.];Change in sleep quality as measured by the smartwatch. Sleep quality is reported by the Fitbit Health App as a score from 0-100.[Using the smartwatch to passively capture sleep data on a daily basis for a period of 1 month. ];Change in step activity. Step activity is reported as total steps taken daily.[Daily step activity will be acquired for a period of 1 month. ];Change in oxygen saturation which is measured as a percentage.[Oxygen saturation will be measured passively through the Fitbit smartwatches over the period of one month whereby daily average oxygen saturations are reported.]