Clinical trial NCT06765889: Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study
Official title: Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness Meditation
Keywords: Mindfulness
Self-Administered Mindfulness
Mental Health
Stress
Decentralized Clinical Trial
Lead sponsor: Institute for Human Development and Potential (IHDP), Singapore
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported stress
timeFrame: 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 outcomes:
measure: Physiological Stress
timeFrame: 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.
measure: Ecological Momentary Assessment - (EMA)
timeFrame: 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 outcomes:
measure: Usability of the intervention
timeFrame: One time, during day 3 of the clinical trial.
measure: Perceived Awareness of the Research Hypothesis
timeFrame: One time, during day 3 of the clinical trial.
measure: Expectancy and credibility of the intervention
timeFrame: One time, during day 3 of the clinical trial.
Locations:
city: Singapore
country: Singapore
facility: Brenner Centre for Molecular Medicine
Study officials:
affiliation: A*STAR IHDP
name: Alessandro Sparacio
role: PRINCIPAL_INVESTIGATOR
References: