An interventional study of Formal-Heavy Audio-Guided Mindfulness Training and Balanced Audio-Guided Mindfulness Training in Psychological Stress, sponsored by Institute for Human Development and Potential (IHDP), Singapore. Not yet recruiting at 1 site in Singapore. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Institute for Human Development and Potential (IHDP), Singapore · Not applicable, Interventional, and Other
This is an operational feasibility pilot preceding the main REFORM multi-site randomized controlled trial. Approximately 60 adults across three sites will be randomized equally to one of four remotely delivered audio-guided mental training programmes and will complete 12 sessions over approximately one month.
The purpose of the pilot is to assess the feasibility and functioning of the study procedures, including the Qualtrics survey and randomization workflow, participant adherence and experience, Camera HRV data collection and transfer, compensation procedures, and blinding materials.
Pilot outcomes will be summarized descriptively. The pilot is not designed for confirmatory efficacy testing. Pilot participants will be excluded from all confirmatory analyses of the subsequent main REFORM trial, and pilot data will not be used to calibrate the Bayesian stopping design, nuisance parameters, or Wave 1 recruitment target.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Institute for Human Development and Potential (IHDP), Singapore is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
- Current diagnosis of schizophrenia, bipolar disorder, or major depressive disorder for which the individual is currently receiving pharmacological or psychological treatment.
Twelve remotely delivered audio-guided sessions over approximately one month, comprising eight formal and four informal mindfulness practices (approximately 67% formal practice).
Behavioral: Formal-Heavy Audio-Guided Mindfulness Training
Twelve remotely delivered audio-guided sessions over approximately one month, comprising six formal and six informal mindfulness practices (50% formal practice).
Behavioral: Balanced Audio-Guided Mindfulness Training
Twelve remotely delivered audio-guided sessions over approximately one month, comprising four formal and eight informal mindfulness practices (approximately 33% formal practice).
Behavioral: Informal-Heavy Audio-Guided Mindfulness Training
Twelve remotely delivered structurally matched audio-guided analytical exercises over approximately one month. The active-control sessions are matched to the mindfulness programmes on duration, voice, session architecture, and practice burden while excluding the core mindfulness component.
Behavioral: Analytical Active-Control Training
Twelve remotely delivered audio-guided sessions completed over approximately one month. The programme comprises eight formal and four informal mindfulness practices (approximately 67% formal practice). Each session uses standardized SOMA audio materials and lasts approximately 12 minutes, with additional study assessments surrounding the audio sessions.
Twelve remotely delivered audio-guided sessions completed over approximately one month. The programme comprises six formal and six informal mindfulness practices, corresponding to 50% formal practice. Sessions use standardized SOMA mindfulness audio materials.
Twelve remotely delivered audio-guided sessions completed over approximately one month. The programme comprises four formal and eight informal mindfulness practices, corresponding to approximately 33% formal practice. Sessions use standardized SOMA mindfulness audio materials.
Twelve remotely delivered audio-guided analytical exercises completed over approximately one month. The active-control programme is structurally matched to the mindfulness programmes on duration, narrator, session architecture, and practice burden, while using analytical rather than mindfulness-based processing.
Intervention adherence
Number of the 12 scheduled audio-guided sessions completed by each participant. Session completion and adherence will be summarized descriptively to assess feasibility of the one-month intervention schedule. No quantitative go/no-go threshold is prespecified.
Time frame: Throughout the approximately 1-month intervention period
Feasibility of Camera HRV data acquisition and transfer
Number and proportion of scheduled Camera HRV measurements at Sessions 1, 6, and 12 that are successfully completed, transferred to the designated study inbox, reconciled using the participant study code, archived, and classified as valid according to the application's prespecified validity classification.
Time frame: Sessions 1, 6, and 12, over approximately 1 month
Participant-reported feasibility and experience
Participant experience with the study procedures will be assessed using the optional three-item REFORM Pilot Feedback Survey. Item-level responses will be summarized descriptively.
Time frame: At Session 12, approximately 1 month after enrollment
Plan to share: Undecided — The process pilot is operational and separate from the confirmatory REFORM trial. A separate individual-participant-data sharing plan for the pilot has not yet been finalized. Any future sharing will follow applicable ethics approvals, institutional data-governance requirements, and appropriate de-identification procedures.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Institute for Human Development and Potential (IHDP), Singapore