MoodNCT06115590
Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population
A study testing Nutritional supplement in people with Mood, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- Nutritional supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Aug 2023to 18 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Nutritional supplement
- Keywords
- Digital Biomarkers, Mood, Stress, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementDietary supplement
Nutritional intervention hypothesized to have an acute anxiolytic effect
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days
Secondary outcomes (7)
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
Measured: 7 days
Activity
Activity level, including #steps, distance traveled, and floors climbed, is measured using a Fitbit Sense 2 smart watch.
Measured: 7 days
Respiratory rate
Respiratory rate (breaths per minute) is measured using a Fitbit Sense 2 smart watch.
Measured: 7 days
Heart rate
Heart rate (beats per minute) is continuously measured using a Fitbit Sense 2 smart watch.
Measured: 7 days
Sleep
Sleep duration (minutes) and quality are measured using a Fitbit Sense 2 smart watch.
Measured: 7 days
Blood oxygenation level (SpO2)
Blood oxygenation level (%) is measured using a Fitbit Sense 2 smart watch.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start24 Aug 2023
- Primary completion18 Feb 2024
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8-day parallel-group design with decentralized data collection
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- OBVIO HEALTH USA, Inc.
- Responsible party
- Principal investigator, Jeroen Schmitt, Institute for Human Development and Potential (IHDP), Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115590
- Sponsor's protocol ID
- 2023-018
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population
- ClinicalTrials.gov ID
- NCT06115590
- Acronym / sponsor ID
- 2023-018
- Conditions
- Mood
- Keywords
- Digital Biomarkers, Mood, Stress, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- OBVIO HEALTH USA, Inc.
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 8-day parallel-group design with decentralized data collection
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Nutritional supplementHalf of the Participants(n=40) with High stress (PSS score >13) will be randomly assigned to this group |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementNutritional intervention hypothesized to have an acute anxiolytic effect | Dietary supplement | Elevated Stress intervention |
Primary outcome
Depression Anxiety and Stress Scale 21 (DASS-21)
Time frame: 7 days
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.
State Trait Anxiety Inventory (STAI-6) 23
Time frame: 7 days
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 secondary outcomes
Ecological Momentary Assessment
Time frame: 7 days
Activity
Time frame: 7 days
Respiratory rate
Time frame: 7 days
Heart rate
Time frame: 7 days
Sleep
Time frame: 7 days
Blood oxygenation level (SpO2)
Time frame: 7 days
Electrodermal activity (EDA)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplement in people with Mood, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety and Stress Scale 21 (DASS-21) (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.