NCT06115590

Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Institute for Human Development and Potential (IHDP), Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional supplement	Nutritional intervention hypothesized to have an acute anxiolytic effect

Timeline

• Start date: 2023-08-24
• Primary completion: 2024-02-18
• Completion: 2024-02-18
• First posted: 2023-11-03
• Last updated: 2024-08-16

Locations

1 site across 1 country: Singapore