Trial Outcomes & Findings for Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study (NCT NCT06765889)
NCT ID: NCT06765889
Last Updated: 2025-07-01
Results Overview
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.
COMPLETED
NA
60 participants
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
2025-07-01
Participant Flow
Participant milestones
| Measure |
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).
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).
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Sham Meditation
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.
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|---|---|---|
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Overall Study
STARTED
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30
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30
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Overall Study
COMPLETED
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29
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30
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Overall Study
NOT COMPLETED
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1
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study
Baseline characteristics by cohort
| Measure |
Sham Meditation
n=30 Participants
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.
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Mindfulness Meditation
n=30 Participants
The intervention included three unique guided practices, each designed to strengthen attentional stability and meta-awareness-key mechanisms associated with effective mindfulness training and stress regulation (Moore et al., 2012; Dahl et al., 2015; Stein et al., 2020). The sessions focused on the following elements:
Attentional Stability: Participants were guided to anchor their focus on present-moment bodily experiences, such as breath sensations, physical posture, or environmental stimuli, to enhance their ability to sustain attention without distraction.
Mindful Meta-Awareness: The practice encouraged nonreactive and nonjudgmental observation of thoughts, emotions, and bodily sensations, fostering acceptance and self-regulation skills.
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Total
n=60 Participants
Total of all reporting groups
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Age, Continuous
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31.60 years
STANDARD_DEVIATION 12.20 • n=5 Participants
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36.20 years
STANDARD_DEVIATION 12.00 • n=7 Participants
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33.93 years
STANDARD_DEVIATION 12.18 • n=5 Participants
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Sex/Gender, Customized
Male
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12 Participants
n=5 Participants
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26 Participants
n=7 Participants
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38 Participants
n=5 Participants
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Sex/Gender, Customized
Female
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17 Participants
n=5 Participants
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13 Participants
n=7 Participants
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30 Participants
n=5 Participants
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Sex/Gender, Customized
Other
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1 Participants
n=5 Participants
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1 Participants
n=7 Participants
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Chinese
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29 Participants
n=5 Participants
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27 Participants
n=7 Participants
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56 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=5 Participants
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3 Participants
n=7 Participants
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4 Participants
n=5 Participants
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PRIMARY outcome
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 listeningPopulation: We used a Bayesian latent growth curve model in \*\*brms\*\* to assess the effect of the mindfulness intervention on STAI-6 stress scores. The model included fixed effects for time (Pre vs. Post), condition (Mindfulness vs. Sham), their interaction, and Day as a covariate, with random slopes for time by participant. We applied weakly informative priors and used Bayes Factors (BF₁₀) to compare the full model to a null model, evaluating support for the intervention effect.
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.
Outcome measures
| Measure |
Mindfulness
n=30 Participants
The Mindfulness Intervention, using tracks recorded by a certified MBSR instructor, aimed to enhance attentional stability and meta-awareness. Over three days, participants engaged in practices designed to anchor their focus on the present moment. These included a formal body awareness meditation, an informal practice of mindfully brushing their teeth, and a breath awareness exercise. The core of this condition was nonjudgmental observation of one's thoughts, feelings, and bodily sensations.
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Sham
n=30 Participants
the Sham Meditation Condition was crafted to mimic the structure of the mindfulness intervention without its key therapeutic elements. The sham tracks actively discouraged attentional stability and meta-awareness. Instead of focusing on a single anchor, participants were encouraged to let their minds wander, engage in multitasking, and explore thoughts freely. The daily activities included associative thinking, brushing teeth while planning other tasks, and creatively expanding on a chosen thought.
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Self-reported Stress
Day 1 Pre
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1.89 score on a scale
Standard Deviation 0.69
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1.87 score on a scale
Standard Deviation 0.75
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Self-reported Stress
Day1 Post
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1.59 score on a scale
Standard Deviation 0.50
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1.68 score on a scale
Standard Deviation 0.58
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Self-reported Stress
Day 2 Pre
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1.96 score on a scale
Standard Deviation 0.58
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1.89 score on a scale
Standard Deviation 0.76
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Self-reported Stress
Day 2 Post
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1.71 score on a scale
Standard Deviation 0.57
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1.69 score on a scale
Standard Deviation 0.59
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Self-reported Stress
Day 3 Pre
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2 score on a scale
Standard Deviation 0.57
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1.91 score on a scale
Standard Deviation 0.80
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Self-reported Stress
Day 3 Post
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1.63 score on a scale
Standard Deviation 0.49
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1.68 score on a scale
Standard Deviation 0.61
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SECONDARY outcome
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.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).
Outcome measures
Outcome data not reported
SECONDARY outcome
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 immediatelyParticipants 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: One time, during day 3 of the clinical trial.Population: We measure acceptability with means and SD for both groups as the intervention (except for the different audio) was equivalent across conditions (same app to measure HRV, same procedure etc).
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.
Outcome measures
| Measure |
Mindfulness
n=30 Participants
The Mindfulness Intervention, using tracks recorded by a certified MBSR instructor, aimed to enhance attentional stability and meta-awareness. Over three days, participants engaged in practices designed to anchor their focus on the present moment. These included a formal body awareness meditation, an informal practice of mindfully brushing their teeth, and a breath awareness exercise. The core of this condition was nonjudgmental observation of one's thoughts, feelings, and bodily sensations.
|
Sham
n=30 Participants
the Sham Meditation Condition was crafted to mimic the structure of the mindfulness intervention without its key therapeutic elements. The sham tracks actively discouraged attentional stability and meta-awareness. Instead of focusing on a single anchor, participants were encouraged to let their minds wander, engage in multitasking, and explore thoughts freely. The daily activities included associative thinking, brushing teeth while planning other tasks, and creatively expanding on a chosen thought.
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|---|---|---|
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Usability of the Intervention
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4.17 score on a scale
Standard Deviation 0.55
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4.17 score on a scale
Standard Deviation 0.51
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OTHER_PRE_SPECIFIED outcome
Timeframe: One time, during day 3 of the clinical trial.PARH; Rubin 2016 is a four-item quantitative self-report tool designed to assess the possible impact of demand characteristics in research settings. Its purpose is to assist in challenging the notion that observed effects can be attributed to demand characteristics. Participants provide their responses to these statements using a 7-point Likert-type scale, where the options range from strongly disagree (1) to strongly agree (7). Examples of statements include: "I was aware of the researchers' objectives in this study" and "I was uncertain about the researchers" intentions in conducting this research".
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Mindfulness
n=30 Participants
The Mindfulness Intervention, using tracks recorded by a certified MBSR instructor, aimed to enhance attentional stability and meta-awareness. Over three days, participants engaged in practices designed to anchor their focus on the present moment. These included a formal body awareness meditation, an informal practice of mindfully brushing their teeth, and a breath awareness exercise. The core of this condition was nonjudgmental observation of one's thoughts, feelings, and bodily sensations.
|
Sham
n=30 Participants
the Sham Meditation Condition was crafted to mimic the structure of the mindfulness intervention without its key therapeutic elements. The sham tracks actively discouraged attentional stability and meta-awareness. Instead of focusing on a single anchor, participants were encouraged to let their minds wander, engage in multitasking, and explore thoughts freely. The daily activities included associative thinking, brushing teeth while planning other tasks, and creatively expanding on a chosen thought.
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|---|---|---|
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Credibility of the Intervention
Correct Group Identification
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18 Participants
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6 Participants
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Credibility of the Intervention
Wrong Group Identification
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10 Participants
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11 Participants
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Credibility of the Intervention
Excluded answers (confidence <5)
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2 Participants
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13 Participants
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Adverse Events
Both Conditions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place