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

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.

Study Overview

• Status: Recruiting
• Conditions: Mood
• Intervention / Treatment: Dietary supplement: Nutritional supplement

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Schmitt, PhD; Phone Number: 6407 4060; Email: jeroen_schmitt@sics.a-star.edu.sg
• Study Contact Backup: Name: Litali Mohapatra, MSc; Phone Number: 87424624; Email: Litali_Mohapatra@SICS.a-star.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 117609
    • Recruiting
    • Singapore Institute for Clinical Trials
    • Contact: Jeroen Schmitt, PhD; Phone Number: 6407 4060; Email: jeroen_schmitt@sics.a-star.edu.sg
    • Contact: Litali Mohapatra, MSc; Phone Number: 87424624; Email: Litali_Mohapatra@SICS.a-star.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Low Stress; Reference Group
No Intervention: Elevated Stress; Half of the Participants(n=40) with elevated stress (PSS score >13) will be randomly assigned to this group
Experimental: Elevated Stress intervention; Half of the Participants(n=40) with High stress (PSS score >13) will be randomly assigned to this group	Dietary supplement: Nutritional supplement; Nutritional intervention hypothesized to have an acute anxiolytic effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety and Stress Scale 21 (DASS-21)	The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self- report scales designed to measure the emotional states of depression, anxiety and stress in clinical and non-clinical populations. Each of the three DASS-21 scales contains 7 items that are scored on a 4-point Likert scale (0-3). In the current study a modified version is used where subjects rate their symptoms over the past 24 hours, rather than 1 week. This questionnaire will be completed daily at 9 pm.	7 days
State Trait Anxiety Inventory (STAI-6) 23	The STAI-6 is a validated short-form version (6 items) of the 40-item STAI questionnaire, measuring current anxiety symptoms on a 4-point Likert scale. Total score is calculated (range 6-24). This questionnaire will be completed daily at 1 pm.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological Momentary Assessment	In the smartphone application, subject will be prompted four times a day with the following statements. The EMA assessment will occur daily at 9.00 am, 1.00 pm, 5.00 pm, 9.00 pm. Subjects are asked to indicate their current state on a VAS (Visual analog Scale). The score in the scale ranges from 0 to 100. 0 being "Not at all" and 100 being "Very Much". The participants will be asked to respond to the following questions: "Right now, I feel mentally sharp" - to assess perception of cognitive ability "Right now, I feel fatigued" - to assess fatigue/exhaustion directly "Right now, I feel stressed" - to assess stress "Right now, I feel nervous" - to assess nervousness/tension "Right now, I feel depressed" - to assess depression "Right now, I am in a good mood" - to assess joy "Right now, I feel thirsty" - to assess level of thirst "Right now, I feel hungry" - to assess level of hunger "I slept well last night" - to assess subjective sleep quality	7 days
Activity	Activity level, including #steps, distance traveled, and floors climbed, is measured using a Fitbit Sense 2 smart watch.	7 days
Respiratory rate	Respiratory rate (breaths per minute) is measured using a Fitbit Sense 2 smart watch.	7 days
Heart rate	Heart rate (beats per minute) is continuously measured using a Fitbit Sense 2 smart watch.	7 days
Sleep	Sleep duration (minutes) and quality are measured using a Fitbit Sense 2 smart watch.	7 days
Blood oxygenation level (SpO2)	Blood oxygenation level (%) is measured using a Fitbit Sense 2 smart watch.	7 days
Electrodermal activity (EDA)	In four user-initiated 2-min sessions per day, Electrodermal activity is measured via a Fitbit Sense 2 smart watch.	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool microbiome composition	Stool samples will be collected at home on the first test day and analyzed for gut microbiome composition using shotgun metagenomic sequencing.	baseline
stool microbiome functional potential	In addition to mapping the taxonomic abundance, the gut microbiome functional potential will be analysed using Biobakery analysis tools.	baseline

Collaborators and Investigators

• Sponsor: Singapore Institute for Clinical Sciences
• Collaborators: OBVIO HEALTH USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mental Health; Stress; Mood; Digital Biomarkers
• Other Study ID Numbers: 2023-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No