Mindfulness MeditationMISRASNCT06765889
Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study
A study testing Mindfulness intervention in people with Mindfulness Meditation, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Meditation
- What is being tested?
- Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Feb 2025to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Mindfulness Meditation
- Being tested
- Mindfulness intervention, Control condition
- Keywords
- Mindfulness, Self-Administered Mindfulness, Mental Health, Stress, Decentralized Clinical Trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
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).
Control conditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start11 Feb 2025
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mindfulness MeditationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Sparacio, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Alessandro Sparacio, Principal investigator, A*STAR IHDP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765889
- Sponsor's protocol ID
- 2024-102
- Acronym
- MISRAS
- Status last verified
- Jun 2025
- First submitted
- 26 Dec 2024
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40828581
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study
- ClinicalTrials.gov ID
- NCT06765889
- Acronym / sponsor ID
- MISRAS / 2024-102
- Conditions
- Mindfulness Meditation
- Keywords
- Mindfulness, Self-Administered Mindfulness, Mental Health, Stress, Decentralized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention | Experimental | Behavioral: Mindfulness interventionThe 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). |
| Sham meditation | Active comparator | Behavioral: Control conditionThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness interventionThe 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). | Behavioural | Mindfulness intervention |
| Control conditionThe 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. | Behavioural | Sham meditation |
Primary outcome
Self-reported Stress
Time frame: 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 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.
2 secondary outcomes
Physiological Stress
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40828581Sparacio 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Sparacio principal investigator
A*STAR IHDP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention in people with Mindfulness Meditation, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Stress (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.