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

NCT06765889 | Completed Results

• 1 other identifier: 2024-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness Meditation

Keywords

Mindfulness; Self-Administered Mindfulness; Mental Health; Stress; Decentralized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Physiological Stress

  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 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 (3)

• Usability of the Intervention

  One time, during day 3 of the clinical trial.

• Perceived Awareness of the Research Hypothesis

  One time, during day 3 of the clinical trial.

• Credibility of the Intervention

  One time, during day 3 of the clinical trial.

Study Arms (2)

Mindfulness intervention

EXPERIMENTAL

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

Sham meditation

ACTIVE COMPARATOR

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

Interventions

Mindfulness intervention BEHAVIORAL

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).

Mindfulness intervention

Control condition BEHAVIORAL

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.

Sham meditation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Brenner Centre for Molecular Medicine

Singapore, 117609, Singapore

Location

Related Publications (1)

• Sparacio A, Davies JN, Lee E, Schmitt JAJ. Feasibility and Acceptability of a Smartphone-Delivered Mindfulness Intervention for Stress Reduction in Adult Singaporeans: Pilot Randomized Controlled Trial. JMIR Ment Health. 2025 Aug 19;12:e77793. doi: 10.2196/77793.

  PMID: 40828581 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

Several key limitations should be considered when interpreting these findings. First, while the sample size (n=60) was adequate for assessing feasibility, it was underpowered to detect subtle intervention effects or moderation by psychological traits. Second, generalizability is limited to English-speaking, predominantly Chinese Singaporean adults without mental health conditions, and results may not extend to other populations.

Results Point of Contact

• Title: Alessandro Sparacio
• Organization: A*STAR

Alessandro_Sparacio@sics.a-star.edu.sg

80728247

Study Officials

• Alessandro Sparacio

  A*STAR IHDP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 9, 2025
• Study Start: February 11, 2025
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

SG (1)