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

Официальное название

The Standardized Open-source Mindfulness Architecture (SOMA): A Modular, Equity-Engineered Stimulus Library for Mechanistic Mindfulness Research

Обзор

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).

Подробное описание

The SOMA Validation RCT is a proof-of-concept deployment of the Standardized Open-source Mindfulness Architecture (SOMA) library, testing whether the library's two core design goals - mechanistic orthogonality between Mindfulness and Active Control conditions, and equitable accessibility across socioeconomic strata - have been achieved before the library is used in large-scale multi-site efficacy trials.

The study uses a randomized, single-blind, parallel-group 2×2 mixed design. Each participant is randomly assigned to either the Mindfulness condition or the Active Control condition and listens to a single 12-minute audio track. Within each condition, participants are further randomized to one of 16 practice scripts, with approximately equal allocation across scripts. Mindfulness and Active Control scripts are structurally matched on duration, word count, and narrator voice, and cover the same 16 everyday activities and sensory domains - the difference lies exclusively in the cognitive mechanism targeted. Blinding is achieved via a neutral cover story framing both conditions as "Mental Efficiency Training." Researchers analyzing data are not blinded.

Three pre-registered hypotheses are tested. H1 (confirmatory) tests whether the Active Control condition is perceived as equally credible as the Mindfulness condition, using Two One-Sided Tests (equivalence bounds d = ±0.40, one-sided α = .05) on the Credibility and Expectancy Questionnaire (CEQ) composite, with script assignment as covariate. H2 (confirmatory) tests whether the two conditions produce a mechanistic double dissociation - Mindfulness greater than Active Control on the State Mindfulness Scale (SMS) and Active Control greater than Mindfulness on the Analytical Engagement Scale (AES) - using a 2×2 mixed ANOVA (Condition × Measure). The interaction term is the primary confirmatory criterion (α = .05); planned one-tailed contrasts provide confirmatory directional evidence. The SMS measures bottom-up experiential awareness; the AES, developed specifically for this study, measures top-down analytical engagement. H3 (exploratory) tests whether Low-SES and High-SES participants show equivalent experiential responses on a Semantic Differential composite, using an independent-samples t-test plus equivalence test (bounds d = ±0.40).

Primary analyses follow an intention-to-treat approach: all participants who completed the study are included regardless of performance on the Script Comprehension Check. A pre-specified sensitivity analysis repeats all primary analyses excluding participants who fail both Script Comprehension Check items. In the unlikely event that the target N of 360 is not reached within four weeks of launch, data collection will close and analyses will proceed on the achieved sample, with any shortfall reported transparently as a deviation.

Quota sampling is used at the recruitment stage to ensure n = 180 per SES stratum (Low-SES: no university-level degree; High-SES: university-level degree or higher), recruited via two linked studies on the Prolific Academic platform with mutual exclusion between studies. SES is not used as a stratification variable at the randomization stage.

Full pre-registration, analysis code with simulated data, and all stimuli are available at osf.io/m76cg.

Вмешательства

• Поведенческое SOMA Audio-Guided Mental Training Exercise
  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).

Первичные конечные точки

• Credibility/Expectancy Questionnaire (CEQ) composite score [Срок оценки: Immediately after audio exposure (single time point)]
• Mechanistic Double Dissociation: State Mindfulness Scale and Analytical Engagement Scale Interaction Score [Срок оценки: Immediately after audio exposure (single time point)]

Вторичные конечные точки (1)

• Semantic Differential scale [Срок оценки: Immediately after audio exposure (single time point)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Сингапур · 1 центр

• Online — Singapore

Публикации

• 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
• 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, Ny PMID 38862815
• 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
• 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

Идентификаторы

NCT: NCT07556744 · ASTAR-IHDP-2025-108-SOMA-VAL · osf.io/m76cg · 2025-108

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗