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

NCT06765889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-01

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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.

Conditions

  • Mindfulness Meditation

Interventions

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).

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.

Sponsors & Collaborators

  • Institute for Human Development and Potential (IHDP), Singapore

    lead OTHER

Principal Investigators

  • Alessandro Sparacio · A*STAR IHDP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2025-04-09
Completion
2025-04-09

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765889 on ClinicalTrials.gov