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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115590
• Other study ID #: 2023-018
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2023
• Source: Singapore Institute for Clinical Sciences
• Contact: Litali Mohapatra, MSc
• Phone: 87424624
• Email: Litali_Mohapatra[@]SICS.a-star.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood

Intervention

Dietary Supplement:
• Nutritional supplement
Nutritional intervention hypothesized to have an acute anxiolytic effect

Locations

Country	Name	City	State
Singapore	Singapore Institute for Clinical Trials	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore Institute for Clinical Sciences	OBVIO HEALTH USA, Inc.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	stool microbiome functional potential	In addition to mapping the taxonomic abundance, the gut microbiome functional potential will be analysed using Biobakery analysis tools.	baseline
Primary	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
Primary	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	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
Secondary	Activity	Activity level, including #steps, distance traveled, and floors climbed, is measured using a Fitbit Sense 2 smart watch.	7 days
Secondary	Respiratory rate	Respiratory rate (breaths per minute) is measured using a Fitbit Sense 2 smart watch.	7 days
Secondary	Heart rate	Heart rate (beats per minute) is continuously measured using a Fitbit Sense 2 smart watch.	7 days
Secondary	Sleep	Sleep duration (minutes) and quality are measured using a Fitbit Sense 2 smart watch.	7 days
Secondary	Blood oxygenation level (SpO2)	Blood oxygenation level (%) is measured using a Fitbit Sense 2 smart watch.	7 days
Secondary	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