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NOT YET RECRUITING
NCT07888725
NA

Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)

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

View on ClinicalTrials.gov

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. 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.

Official title: REFORM Process Pilot: Feasibility of a Multi-Site Remote Trial Comparing Formal and Informal Mindfulness Practice Ratios

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-11-20

Completion Date

2026-12-20

Last Updated

2026-10-23

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Formal-Heavy Audio-Guided Mindfulness 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.

BEHAVIORAL

Balanced Audio-Guided Mindfulness Training

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.

BEHAVIORAL

Informal-Heavy Audio-Guided Mindfulness Training

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.

BEHAVIORAL

Analytical Active-Control Training

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.

Locations (1)

Participants will be recruited online and will never come to the lab for assessments.

Singapore, Singapore