Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- State Trait Anxiety Inventory (STAI-6) 23
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
State Trait Anxiety Inventory (STAI-6) 23
时间窗: 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.
Depression Anxiety and Stress Scale 21 (DASS-21)
时间窗: 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.
次要结局
- Ecological Momentary Assessment(7 days)
- Heart rate(7 days)
- Blood oxygenation level (SpO2)(7 days)
- Activity(7 days)
- Respiratory rate(7 days)
- Electrodermal activity (EDA)(7 days)
- Sleep(7 days)
研究者
Jeroen Schmitt
Senior Principal Investigator
Institute for Human Development and Potential (IHDP), Singapore