SOMA Validation RCT: Testing Structural Equivalence and Mechanistic Orthogonality of an Open-Source Mindfulness Stimulus Library

NCT07556744 | Not Yet Recruiting

• 3 other identifiers: ASTAR-IHDP-2025-108-SOMA-VALosf.io/m76cg2025-108
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Mindfulness research faces two structural problems. First, weak active control conditions make it impossible to isolate specific mechanisms from expectancy and non-specific effects. Second, most protocols systematically exclude low-socioeconomic status (SES) populations through design assumptions that presuppose high literacy, quiet private spaces, and familiarity with contemplative practice. Objective: This study validates the Standardized Open-source Mindfulness Architecture (SOMA), the first modular, open-source stimulus library purpose-built to address both challenges simultaneously. SOMA comprises 88 distinct audio assets organized around 16 sensory practice modules, each paired with a structurally equivalent active control script engineered to induce analytically orthogonal cognitive processing. Design: Pre-registered randomized controlled trial using a 2×2 mixed design (Condition \[Mindfulness vs. Active Control\] × Measure \[State Mindfulness Scale vs. Analytical Engagement Scale\]), with quota sampling to ensure equal representation of participants with and without a university-level degree (n = 180 per SES stratum). Setting: Online, via Prolific Academic recruitment platform and Qualtrics survey software. Participants: N = 360 English-proficient adults aged 18 years and older (or the applicable minimum age of majority in the participant's country of residence) without a current mental health diagnosis or treatment, and without a current meditation practice. Intervention: Each participant listens to a single 12-minute audio-guided exercise. Participants are randomly assigned to either the Mindfulness condition or the Active Control condition, and within that condition to one of 16 practice scripts. Mindfulness scripts guide bottom-up experiential awareness; Active Control scripts guide top-down analytical processing of the same everyday activities. Primary Outcomes: (1) Credibility and expectancy equivalence between conditions (H1: Two One-Sided Tests on Credibility and Expectancy Questionnaire composite, equivalence bounds d = ±0.40); (2) mechanistic double dissociation - higher state mindfulness in the Mindfulness condition and higher analytical engagement in the Active Control condition (H2: 2×2 mixed ANOVA, interaction term as primary criterion). Exploratory Outcome: SES-related differential experiential accessibility (H3: independent-samples t-test plus equivalence test on Semantic Differential composite by SES group).

Conditions

Mindfulness; Healthy Volunteers

Keywords

Mindfulness; Active Control; Stimulus Library; Mechanistic Research; Open Science; Socioeconomic Status; Credibility; Expectancy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Credibility/Expectancy Questionnaire (CEQ) composite score

  CEQ composite 3-item composite (Logic, Success, Recommendation) from the Credibility and Expectancy Questionnaire (Devilly \& Borkovec, 2000), each item rated on a 1-9 scale (1 = not at all, 9 = extremely). Composite score range: 1-9; higher scores indicate greater perceived credibility and expectancy. Primary outcome for H1 (structural equivalence).

  Immediately after audio exposure (single time point)

• Mechanistic Double Dissociation: State Mindfulness Scale and Analytical Engagement Scale Interaction Score

  State Mindfulness Scale (SMS; Tanay \& Bernstein, 2013): 7 items rated 1-5 (1 = not at all, 5 = very well); range 1-5, higher scores indicate greater state mindfulness. Analytical Engagement Scale (AES; purpose-built for this study): 5 items rated 1-5 (1 = not at all, 5 = very much); range 1-5, higher scores indicate greater analytical engagement.

  Immediately after audio exposure (single time point)

Secondary Outcomes (1)

• Semantic Differential scale

  Immediately after audio exposure (single time point)

Other Outcomes (3)

• CEQ Item 3 (Wellbeing) - exploratory

  Immediately after audio exposure

• Perceived Nature / Blinding Check

  Immediately after audio exposure

• Audio Clarity, Cognitive Demand, Instruction Clarity

  Immediately after audio exposure

Study Arms (2)

Mindfulness Condition

EXPERIMENTAL

Participants listen to one 12-minute SOMA Mindfulness audio track randomly assigned from 16 script pairings. Tracks guide bottom-up experiential awareness of everyday sensory and bodily experience (e.g., body scan, mindful walking, mindful eating, awareness of breath). All tracks are narrated by the same voice actor under identical recording conditions.

Behavioral: SOMA Audio-Guided Mental Training Exercise

Active Control Condition

ACTIVE COMPARATOR

Participants listen to one 12-minute SOMA Active Control audio track matched to the same practice domain as the assigned Mindfulness track. Tracks guide top-down analytical processing of the same activities (e.g., seating area analysis, spatial navigation exercise, meal organization, weekly schedule optimization). Matched to Mindfulness tracks on duration (±30 seconds), word count (898-957 words), narrator voice, and recording conditions.

Behavioral: SOMA Audio-Guided Mental Training Exercise

Interventions

SOMA Audio-Guided Mental Training Exercise BEHAVIORAL

A single 12-minute audio-guided exercise from the Standardized Open-source Mindfulness Architecture (SOMA) library. The SOMA library comprises 88 distinct assets organized around 16 sensory practice modules (formal and informal) paired with structurally equivalent active control scripts. All materials are equity-engineered to a Grade 5-6 reading level, deployable without a meditation teacher, and free under CC BY-NC-SA 4.0 (osf.io/m76cg).

Active Control Condition; Mindfulness Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older (or the legal age of majority in the participant's country of residence, whichever is higher)
• Fluent in English (English as first language or self-reported fluent language)
• Able to listen to a 12-minute audio recording with headphones, earphones, or device speaker
• Access to a device capable of completing an online survey

You may not qualify if:

• Current diagnosis of a mental health condition
• Currently receiving or waiting for treatment for mental health symptoms (e.g., psychological therapy or psychiatric medication)
• Regular yoga or meditation practice in the last six months

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• The University of Queensland: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (1)

Online

Singapore, Singapore

Location

Related Publications (4)

• 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.

  PMID: 40828581 BACKGROUND

• Sparacio A, IJzerman H, Ropovik I, Giorgini F, Spiessens C, Uchino BN, Landvatter J, Tacana T, Diller SJ, Derrick JL, Segundo J, Pierce JD, Ross RM, Francis Z, LaBoucane A, Ma-Kellams C, Ford MB, Schmidt K, Wong CC, Higgins WC, Stone BM, Stanley SK, Ribeiro G, Fuglestad PT, Jaklin V, Kubler A, Ziebell P, Jewell CL, Kovas Y, Allahghadri M, Fransham C, Baranski MF, Burgess H, Benz ABE, DeSousa M, Nylin CE, Brooks JC, Goldsmith CM, Benson JM, Griffin SM, Dunne S, Davis WE, Watermeyer TJ, Meese WB, Howell JL, Standiford Reyes L, Strickland MG, Dickerson SS, Pescatore S, Skakoon-Sparling S, Wunder ZI, Day MV, Brenton S, Linden AH, Hawk CE, O'Brien LV, Urgyen T, McDonald JS, van der Schans KL, Blocker H, Ng Tseung-Wong C, Jiga-Boy GM. Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study. Nat Hum Behav. 2024 Sep;8(9):1716-1725. doi: 10.1038/s41562-024-01907-7. Epub 2024 Jun 11.

  PMID: 38862815 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Tanay G, Bernstein A. State Mindfulness Scale (SMS): development and initial validation. Psychol Assess. 2013 Dec;25(4):1286-99. doi: 10.1037/a0034044. Epub 2013 Sep 23.

  PMID: 24059475 BACKGROUND

Related Links

• The OSF page of the project with all the relevant study documentation.

Central Study Contacts

Alessandro Sparacio, Ph.D. In Psychology

CONTACT

8072 8247; Alessandro_Sparacio@a-star.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to condition assignment via a neutral cover story ("An Investigation of Audio-Guided Mental Training for Focus and Perception"). Both conditions are presented under a "Mental Efficiency Training" rubric within the survey. Investigators and outcome assessors are not blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel-group design. Participants are randomly assigned 1:1 to either the Mindfulness condition or the Active Control condition. Each participant completes a single session only. The within-subjects factor (Measure: SMS vs. AES) is administered to all participants regardless of condition assignment, creating a 2×2 mixed design.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 29, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data and all supporting information will be available on the Open Science Framework (osf.io/m76cg) within 12 months of primary study completion. Data will remain publicly accessible indefinitely.
• Access Criteria: Open access. No registration or application required. All de-identified data, analysis code, study protocol, statistical analysis plan, and informed consent form will be freely available for download at osf.io/m76cg. Data are shared under CC BY-NC-SA 4.0 - free for academic, clinical, and public research use.

Locations

SG (1)