Psychological StressREFORM PilotNCT07888725
Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)
A study testing Formal-Heavy Audio-Guided Mindfulness Training, Balanced Audio-Guided Mindfulness Training and Informal-Heavy Audio-Guided Mindfulness Training in people with Psychological Stress, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Formal-Heavy Audio-Guided Mindfulness Training, Balanced Audio-Guided Mindfulness Training and Informal-Heavy Audio-Guided Mindfulness Training
- 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
- 20 Nov 2026to 20 Dec 2026
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has reached the legal age of majority in their country of residence.
- Self-reports advanced English proficiency, sufficient to understand all spoken and written study instructions without communication barriers.
- Reports no regular yoga or meditation practice during the preceding six months, defined as selecting either "Never" or "Rarely (1-3 times in total)".
- Has sufficient vision and hearing to read on-screen instructions and listen to the audio recordings.
- Owns a smartphone capable of accessing the Qualtrics survey and installing the Camera HRV application.
Who cannot join
- Current diagnosis of schizophrenia, bipolar disorder, or major depressive disorder for which the individual is currently receiving pharmacological or psychological treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Participants will be recruited online and will never come to the lab for assessments.
Singapore
About this study
Official title: REFORM Process Pilot: Feasibility of a Multi-Site Remote Trial Comparing Formal and Informal Mindfulness Practice Ratios
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.
- Conditions
- Psychological Stress
- Being tested
- Formal-Heavy Audio-Guided Mindfulness Training, Balanced Audio-Guided Mindfulness Training, Informal-Heavy Audio-Guided Mindfulness Training, Analytical Active-Control Training
- Keywords
- Feasibility, Audio-Guided Mental Training, Remote Behavioral Intervention, Heart Rate Variability, Multi-Site Trial
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal-Heavy Audio-Guided Mindfulness TrainingBehavioural
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.
Balanced Audio-Guided Mindfulness TrainingBehavioural
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.
Informal-Heavy Audio-Guided Mindfulness TrainingBehavioural
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.
Analytical Active-Control TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Formal-Heavy Audio-Guided Training | Experimental | Twelve remotely delivered audio-guided sessions over approximately one month, comprising eight formal and four informal mindfulness practices (approximately 67% formal practice). Receives: Behavioral: Formal-Heavy Audio-Guided Mindfulness Training |
| Balanced Audio-Guided Training | Experimental | Twelve remotely delivered audio-guided sessions over approximately one month, comprising six formal and six informal mindfulness practices (50% formal practice). Receives: Behavioral: Balanced Audio-Guided Mindfulness Training |
| Informal-Heavy Audio-Guided Training | Experimental | Twelve remotely delivered audio-guided sessions over approximately one month, comprising four formal and eight informal mindfulness practices (approximately 33% formal practice). Receives: Behavioral: Informal-Heavy Audio-Guided Mindfulness Training |
| Analytical Active-Control Training | Active comparator | 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. Receives: Behavioral: Analytical Active-Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the approximately 1-month intervention period
Secondary outcomes (2)
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.
Measured: 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.
Measured: At Session 12, approximately 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1:1 ratio to one of four audio-guided training tracks and will complete 12 sessions over approximately one month. The pilot evaluates operational feasibility and study procedures and is not designed for confirmatory efficacy testing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888725
- Sponsor's protocol ID
- REFORM-PILOT-2026
- Other IDs
- OFYIRG25jan-0043, 2025-108
- Acronym
- REFORM Pilot
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.