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

NCT06115590 | Completed DMC

• 1 other identifier: 2023-018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Digital Biomarkers; Mood; Stress; Mental Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Ecological Momentary Assessment

  7 days

• Activity

  7 days

• Respiratory rate

  7 days

• Heart rate

  7 days

• Sleep

  7 days

Other Outcomes (2)

• Stool microbiome composition

  baseline

• stool microbiome functional potential

  baseline

Study Arms (3)

Low Stress

NO INTERVENTION

Reference Group

Elevated Stress

NO INTERVENTION

Half of the Participants(n=40) with elevated stress (PSS score \>13) will be randomly assigned to this group

Elevated Stress intervention

EXPERIMENTAL

Half of the Participants(n=40) with High stress (PSS score \>13) will be randomly assigned to this group

Dietary Supplement: Nutritional supplement

Interventions

Nutritional supplement DIETARY_SUPPLEMENT

Nutritional intervention hypothesized to have an acute anxiolytic effect

Elevated Stress intervention

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• OBVIO HEALTH USA, Inc.: collaborator

Study Sites (1)

Singapore Institute for Clinical Trials

Singapore, 117609, Singapore

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Investigator

Model Details: 8-day parallel-group design with decentralized data collection

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 3, 2023
• Study Start: August 24, 2023
• Primary Completion: February 18, 2024
• Study Completion: February 18, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)