NCT06765889: MISRAS

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

Completed NA Results posted Last updated 1 July 2025

What this trial tests

NA trial testing Mindfulness intervention in Mindfulness Meditation in 60 participants. Completed in 9 April 2025.

Timeline

11 February 2025

Primary endpoint
9 April 2025

9 April 2025

Quick facts

Lead sponsor	Institute for Human Development and Potential (IHDP), Singapore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	11 February 2025
Primary completion	9 April 2025
Estimated completion	9 April 2025
Sites	1 location across Singapore

Drugs / interventions tested

• Mindfulness intervention
• Control condition

Conditions studied

• Mindfulness Meditation — all drugs for Mindfulness Meditation →

Sponsor

Institute for Human Development and Potential (IHDP), Singapore

Who can join

21 and older, any sex, with Mindfulness Meditation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Stress Primary · 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

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

Day 1 Pre

Group	Value	95% CI
Mindfulness	1.89	± 0.69
Sham	1.87	± 0.75

Day1 Post

Group	Value	95% CI
Mindfulness	1.59	± 0.50
Sham	1.68	± 0.58

Day 2 Pre

Group	Value	95% CI
Mindfulness	1.96	± 0.58
Sham	1.89	± 0.76

Day 2 Post

Group	Value	95% CI
Mindfulness	1.71	± 0.57
Sham	1.69	± 0.59

Day 3 Pre

Group	Value	95% CI
Mindfulness	2	± 0.57
Sham	1.91	± 0.80

Day 3 Post

Group	Value	95% CI
Mindfulness	1.63	± 0.49
Sham	1.68	± 0.61

Usability of the Intervention Secondary · One time, during day 3 of the clinical trial.

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.

Group	Value	95% CI
Mindfulness	4.17	± 0.55
Sham Meditation	4.17	± 0.51

Credibility of the Intervention Secondary · One time, during day 3 of the clinical trial.

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

Correct Group Identification

Group	Value	95% CI
Mindfulness	18
Sham Meditation	6

Wrong Group Identification

Group	Value	95% CI
Mindfulness	10
Sham Meditation	11

Excluded answers (confidence <5)

Group	Value	95% CI
Mindfulness	2
Sham Meditation	13

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility and Acceptability of a Smartphone-Delivered Mindfulness Intervention for Stress Reduction in Adult Singaporeans: Pilot Randomized Controlled Trial.
   Sparacio A, Davies JN, Lee E, Schmitt JAJ. · · 2025 · cited 1× · PMID 40828581 · DOI 10.2196/77793
2. Feasibility and Acceptability of a Self-Administered Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans: A Pilot Study
   Sparacio A, Davies JN, Lee E, Schmitt J. · · 2025 · DOI 10.31234/osf.io/v37ac_v1