Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study (MISRAS)

This pilot study investigates self-administered mindfulness (SAM) as a stress reduction intervention, serving as a feasibility assessment for a larger multi-site trial. The research addresses gaps in mindfulness literature, particularly timely given that stress profoundly affects individuals' lives, shaping their thoughts, behaviors, and emotional experiences (Aldwin, 2007; Lazarus & Folkman, 1984), and plays a significant role in conditions like depression and anxiety (Yang et al., 2015).

The study implements a sham meditation control condition, improving upon passive controls that often yield inflated effect sizes (Patterson et al., 2016). The methodology incorporates both subjective measures, addressing limitations noted by Nichols et al. (2008), and heart rate variability (HRV) measurements. HRV has proven useful for its sensitivity to stress-induced changes (Goldberger et al., 2001), with higher values indicating better parasympathetic recovery (Shaffer & Ginsberg, 2017; Michels et al., 2013).

Set in Singapore, where stress management is a significant concern (Chodavadia et al., 2023), the study builds on Kabat-Zinn's (2003, 2006) definition of mindfulness. Unlike traditional programs, these interventions are more accessible (Spijkerman et al., 2016).

Recent meta-analyses show mixed findings: some identified small but significant effects (Cavanagh et al., 2018; Taylor et al., 2021), while others found no evidence of effectiveness after accounting for publication bias (Sparacio et al., 2024a). The study considers Singapore's unique cultural position (Li, Ngin, & Teo, 2007) and utilizes smartphone-based HRV monitoring, supported by research validating PPG technology (Guede-Fernández et al., 2020).

Through its comprehensive approach and robust design, this pilot study aims to establish a foundation for future research while providing insights into SAM's effectiveness as a stress reduction technique.

Study Overview

• Status: Completed
• Conditions: Mindfulness Meditation
• Intervention / Treatment: Behavioral: Mindfulness intervention; Behavioral: Control condition

Detailed Description

This pilot study will implement a fully decentralized approach to investigate self-administered mindfulness (SAM) interventions, leveraging digital tools to streamline the research process without requiring physical interaction between research teams and participants. The decentralized framework particularly suits SAM interventions due to their inherent flexibility and seamless integration into participants' daily routines.

The study will address critical methodological gaps in mindfulness research through a rigorous randomized, double-blind, two-arm parallel-groups design. To differentiate between genuine effects and expectation-related processes, the study will employ a sham meditation control condition, where participants will be led to believe they are practicing meditation. This control condition will maintain structural equivalence with the mindfulness intervention while deliberately excluding two fundamental processes: attentional anchoring and guidance on cultivating mindful meta-cognitive qualities.

The study will utilize a comprehensive digital infrastructure for data collection and intervention delivery. The current clinical trial will be conducted over a three-day period and will be administered entirely remotely, with participants engaging from their homes by accessing a Qualtrics link.

For objective stress measurement, the study will utilize smartphone-based heart rate variability (HRV) assessment via a validated app employing photoplethysmogram (PPG) technology. This approach is consistent with established methods for assessing physiological markers of stress during resting states. The smartphone-based measurement strategy will enable participants to engage in the study from their homes, potentially enhancing ecological validity and participant retention.

The study will implement a robust system for participant management and data security. Phone numbers will be retained temporarily for specific operational purposes: preventing multiple submissions, facilitating study material delivery, and ensuring compensation via an electronic payment system. To maintain anonymity, all collected data except phone numbers will be de-identified. The study coordinator will implement checks for duplicate numbers to maintain data integrity.

Participants will be organized into cohorts of approximately 20 individuals, with recruitment continuing until the target sample size is reached. Each cohort will begin the study within three weeks of recruitment completion, ensuring efficient study progression while maintaining manageable group sizes for monitoring and support.

The mindfulness intervention will incorporate three distinct tracks adapted from traditional mindfulness protocols. These tracks will focus on two essential elements: cultivating attentional stability through present-moment bodily awareness and fostering mindful meta-awareness through nonreactivity and nonjudgmental observation. The selection of these components is based on established findings regarding effective stress regulation in mindfulness training.

The sham meditation control will be carefully designed to be indistinguishable from genuine meditation practice for newcomers, incorporating non-specific elements such as soothing voice and appropriate terminology. However, it will intentionally omit the core cognitive and meta-cognitive processes essential to mindfulness practice, providing neither specific attention anchoring nor guidance on mindful attention qualities.

The study will implement a comprehensive assessment protocol, including both psychological and physiological measures. Participants will complete assessments at consistent times between 9 AM and 9 PM daily. The protocol will include:

Baseline psychological assessments using validated instruments:

Neuroticism assessment Resilience measurement Mindfulness assessment, focusing on key facets of mindfulness based on recent confirmatory factor analysis

Daily pre- and post-intervention assessments:

Self-reported stress assessment Ecological Momentary Assessment (EMA) for real-time state evaluation HRV measurements using standardized protocols

End of study assessments:

Mindfulness assessment, focusing on key facets of mindfulness based on recent confirmatory factor analysis Perceived Awareness of Research Hypothesis (PARH) to control for demand characteristics Intervention credibility and expectancy evaluation Comprehensive feedback on protocol usability and participant experience Participants will receive detailed instructions for proper finger placement during HRV measurements. The app will automatically validate measurement quality, requiring repeat assessments (up to two additional attempts) if initial measurements fail quality standards. All HRV data will be saved in CSV format for subsequent analysis.

The decentralized approach aims to overcome traditional trial challenges such as geographical constraints, limited diversity, and logistical barriers that typically hinder participant engagement. This methodology will particularly benefit participants who may have difficulty accessing study locations or lack time to participate in traditional trials, potentially leading to a more diverse and representative study population.

This pilot investigation will serve as a feasibility assessment for a planned larger multi-site trial, with special attention paid to the credibility and usability of the survey-based methodology. Post-intervention questionnaires will collect participant feedback on survey instruction clarity, navigation ease, and overall user experience, informing methodology refinements for future larger-scale, fully decentralized studies on SAM.

Future Applications and Cultural Considerations Given Singapore's position at the intersection of Eastern and Western cultures, findings from this feasibility study will provide valuable insights for future international studies bridging diverse cultural contexts. The results will help establish a foundation for developing cost-effective, accessible stress management strategies while advancing our understanding of decentralized trial methodologies in mindfulness research.

The study's innovative approach to decentralized intervention delivery and data collection will provide valuable insights for future remote clinical trials, potentially influencing the design and implementation of similar studies across various behavioral interventions and cultural contexts.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117609
    • Brenner Centre for Molecular Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Be at least 21 years old.
2. Possess a smartphone capable of running the study applications with internet access.
3. Be fluent in the English language.
4. Have sufficient vision and hearing to complete the study procedures.

Exclusion Criteria:

1. Engaged in meditation within the six months preceding the experiment.
2. Member of the research team or an immediate family member (defined as spouses, parents, children, or siblings, whether biological or legally adopted).
3. Currently taking psychoactive medications, including antidepressants, anxiolytics, hypnotics, or stimulants, or having used these medications in the past week.
4. History of major neurological or psychiatric disease within the past six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness intervention; The mindfulness intervention will consist of three tracks of mindfulness practice adapted from a traditional Mindfulness-Based Stress Reduction (MBSR) protocol. The three mindfulness tracks will incorporate essential elements of mindfulness practice: a) cultivating attentional stability by directing focus to present-moment bodily experiences (Moore et al., 2012), and b) fostering mindful meta-awareness by nonreactively and nonjudgmentally observing and accepting experiences (Dahl et al., 2015).	Behavioral: Mindfulness intervention; The mindfulness intervention will consist of three tracks of mindfulness practice adapted from a traditional Mindfulness-Based Stress Reduction (MBSR) protocol. The three mindfulness tracks will incorporate essential elements of mindfulness practice: a) cultivating attentional stability by directing focus to present-moment bodily experiences (Moore et al., 2012), and b) fostering mindful meta-awareness by nonreactively and nonjudgmentally observing and accepting experiences (Dahl et al., 2015).
Active Comparator: Sham meditation; The sham meditation group will aim to be indistinguishable from meditation practice for newcomers (Zeidan et al., 2015). Non-specific elements of meditation, such as a soothing instructor's voice and terminology designed to create the expectation of authentic mindfulness meditation for those unfamiliar with the practice, will be emphasized. However, the instructions will deliberately exclude the training of the two fundamental cognitive/meta-cognitive processes crucial in mindfulness practice. This intentional omission will involve 1) removing any attentional stability by providing participants with no specific point to anchor their attention and 2) offering no guidance on cultivating mindful meta-cognitive qualities of attention. Participants in the mindfulness group will be taught to observe and accept their present-moment experience without judgment or reaction. In contrast, sham instructions will provide no such guidance.	Behavioral: Control condition; The sham meditation group will aim to be indistinguishable from meditation practice for newcomers (Zeidan et al., 2015). Non-specific elements of meditation, such as a soothing instructor's voice and terminology designed to create the expectation of authentic mindfulness meditation for those unfamiliar with the practice, will be emphasized. However, the instructions will deliberately exclude the training of the two fundamental cognitive/meta-cognitive processes crucial in mindfulness practice. This intentional omission will involve 1) removing any attentional stability by providing participants with no specific point to anchor their attention and 2) offering no guidance on cultivating mindful meta-cognitive qualities of attention. Participants in the mindfulness group will be taught to observe and accept their present-moment experience without judgment or reaction. In contrast, sham instructions will provide no such guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Stress	We will measure self-reported acute stress using the State-Trait Anxiety Inventory - Short Form (STAI-6), a validated 6-item version of the 40-item State-Trait Anxiety Inventory developed by Marteau and Bekker. The STAI-6 assesses current (state) anxiety symptoms using a 4-point Likert scale ranging from 1 (Not at all) to 4 (Very much). Example items include "I feel calm" and "I am tense." For data analysis, the mean score of the 6 items was calculated. Therefore, scores range from 1 to 4, with higher scores indicating greater levels of acute stress (worse outcome). In the table, the averaged score for STAI-6 at pre/post assessments for each of the three days of the intervention is provided. Results for the two conditions are provided.	Participants will complete the STAI-6 assessment six times throughout the trial, once per day on Days 1 through 3. On each day, they will report their STAI-6 levels twice: once before listening to the audio track and once immediately after listening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Stress	Heart Rate Variability. To assess parasympathetic activation, participants' heart rate variability (HRV) will be analyzed. HRV is widely recognized as a sensitive marker of stress, regulated by the autonomic nervous system in response to stressors (Goldberger et al., 2001). Participants will monitor their HRV using the 'Camera Heart Rate Variability' smartphone app, which employs Photoplethysmogram (PPG) technology. Notably, smartphone apps utilizing PPG for heart rate measurement have shown consistency with validated methods such as electrocardiography (ECG) in adult populations during resting states (Guede-Fernández et al., 2020) Participants will be instructed to place their index finger over the smartphone's camera and flash, ensuring both are fully covered. They will hold their finger in place for one minute to allow the device to record their heart rate variability (HRV).	Participants will assess their HRV values seven times over the course of the trial (from Day 1 to Day 3). The first measurement will be a test, the first and second measurement each day will be taken before and after listening to the audio track.
Ecological Momentary Assessment - (EMA)	Participants will indicate their current state using a slider scale from 1 (not at all) to 100 (very much). The following questions will be used to assess various psychological and physical states: "Right now, I feel mentally sharp" - to assess perceived cognitive ability.; "Right now, I feel fatigued" - to assess fatigue and exhaustion.; "Right now, I feel stressed" - to assess stress levels.; "Right now, I feel nervous" - to assess nervousness and tension.; "Right now, I feel depressed" - to assess depressive symptoms.; "Right now, I am in a good mood" - to assess positive affect and joy.; "I slept well last night" - to assess subjective sleep quality.	Participants will complete the Ecological Momentary Assessments (EMAs) six times throughout the trial, once per day on Days 1 through 3. On each day, they will report their EMAs levels twice: once before listening to the audio track and once immediately

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Awareness of the Research Hypothesis	PARH; Rubin 2016 is a four-item quantitative self-report tool designed to assess the possible impact of demand characteristics in research settings. Its purpose is to assist in challenging the notion that observed effects can be attributed to demand characteristics. Participants provide their responses to these statements using a 7-point Likert-type scale, where the options range from strongly disagree (1) to strongly agree (7). Examples of statements include: "I was aware of the researchers' objectives in this study" and "I was uncertain about the researchers" intentions in conducting this research".	One time, during day 3 of the clinical trial.
Usability of the Intervention	To assess the usability and acceptability of the pilot trial, participants from both the mindfulness and sham conditions completed a questionnaire after the final session. It evaluated dimensions including ease of use, clarity, engagement, relevance, and willingness to continue use. Items were rated on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree), with higher scores indicating greater perceived usability.	One time, during day 3 of the clinical trial.
Credibility of the Intervention	To evaluate credibility, participants responded to a two-part question: "If you were informed that you might have received either meditation training or control training, which type do you believe you received? (Meditation, Control)". Furthermore, we asked to participants how confident were about that answer on a scale from 0 to 10. In the following table we excluded answers where their confidence about the answer was <5	One time, during day 3 of the clinical trial.

Collaborators and Investigators

• Sponsor: Institute for Human Development and Potential (IHDP), Singapore
• Investigators: Principal Investigator: Alessandro Sparacio, A*STAR IHDP

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; Stress; Mindfulness; Self-Administered Mindfulness; Decentralized Clinical Trial
• Other Study ID Numbers: 2024-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All data collected in the research study will be de-identified. Electronic data will be stored on a secure, password-protected computer, accessible only to the researchers.

Phone numbers collected for reimbursement purposes and to prevent re-attempts of the study will be deleted upon completion of data collection.

De-identified research data will be stored and analyzed and may be used for future research and deposited in an online public repository.

• IPD Sharing Time Frame: After the start of the project both hardcopy and electronic data will be retained for a maximum of 10 years, after which they will be destroyed. Any future research arising from the collected data will be subject to review by the relevant institutional review board.
• IPD Sharing Access Criteria: Access to research data will be restricted to the Principal Investigator (PI), and the study team. Access will be controlled and monitored through password-protected systems available only to authorized personnel.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No