Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporea… (NCT06115590) | Clinical Trial Compass
CompletedNot Applicable
Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population
Singapore120 participantsStarted 2023-08-24
Plain-language summary
The investigators aim to assess the relationship between objectives markers (of physiological reactivity) recorded using a smartwatch and self-reported subjective outcomes measured using standardized and non-standardized questionnaires recorded in an eDiary; with stress as the model for our assessment utilizing the validated PSS-10 questionnaire.
As personal characteristics such as personality traits, resilience, and grit have been shown to modulate reactivity and mental health status, the investigators aim to explore the modulation of the study outcomes by such personality factors. Furthermore, the investigators aim to explore the association of the study outcomes with the composition and functional potential of the gut microbiome.
Finally, the investigators aim to explore the effects of a nutritional intervention on our outcome measures.
Participants will participate in a decentralized, parallel-group study with a mixed design lasting 8 days (excluding screening and enrollment). A total of 120 participants are divided into low-stress(n=40), and elevated-stress groups (n=80) based on their perceived stress score (PSS-10, cut-off score 13). A subgroup of elevated-stress participants (n=40) will be administered a nutritional intervention for 3 days. Their responses will be compared to another subgroup of elevated-stress participants (n=40) without intervention.
Who can participate
Age range
21 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 21 to 30 years
* Own and uses a smartphone that is capable of running the study applications
* Have access to the internet
* Adequate fluency in the English language to understand the informed consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures
* Willing to commit to about 20 minutes of assessments each day for a period of 8 days
* Willing to wear selected study devices 24 hours/day; 7-days per week with only occasional relief
* Willing and able to participate and to give written informed consent
Exclusion Criteria:
* Past (\< 6 months prior to the study) or current neurological or psychiatric condition
* Past (\< 3 months prior to the study) or current use of psychoactive medication
* Having received antibiotic treatment \< 4 weeks prior to the study
* Present or past history of alcohol or drug addiction and/or recreational drug use
* Maltodextrin allergy
* Members of the research team or their immediate family members. An immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
* Women participants who are currently pregnant or have been pregnant in past 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression Anxiety and Stress Scale 21 (DASS-21)
Timeframe: 7 days
2
State Trait Anxiety Inventory (STAI-6) 23
Timeframe: 7 days
Trial details
NCT IDNCT06115590
SponsorInstitute for Human Development and Potential (IHDP), Singapore