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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute for Human Development and Potential (IHDP), Singapore

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Mindfulness ConditionExperimental treatment 1 intervention
Group B: Active Control ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Immediately after audio exposure (single time point)
2

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.

Time frame
Immediately after audio exposure (single time point)

Secondary outcomes

1

Semantic Differential scale

Three bipolar 7-point items assessing subjective experiential quality of the exercise: Sensing/Feeling vs. Analysing/Estimating; Judging/Correcting vs. Accepting/Allowing; Past or Future vs. Here and Now. Composite score range: 1-7; higher scores indicate a more mindfulness-consistent experiential quality.

Time frame
Immediately after audio exposure (single time point)

Other outcomes

1

CEQ Item 3 (Wellbeing) - exploratory

Single item assessing emotional outcome expectancy, analysed separately from the primary H1 composite.

Time frame
Immediately after audio exposure
2

Perceived Nature / Blinding Check

Mechanism identification item (categorical, 5 options) and confidence rating slider (0-100%). Outcome-neutral quality check for blinding adequacy.

Time frame
Immediately after audio exposure
3

Audio Clarity, Cognitive Demand, Instruction Clarity

Outcome 6a - Audio Clarity Single item: "How clear was the audio quality of the recording?" rated on a 5-point scale (1 = very unclear, 5 = very clear). Reported descriptively. Outcome 6b - Cognitive Demand Single item: "How mentally demanding did you find this exercise?" rated on a 5-point scale (1 = not at all demanding, 5 = extremely demanding). Reported descriptively. Outcome 6c - Instruction Clarity Single item: "How easy was it to follow the instructions in the exercise?" rated on a 5-point scale (1 = very difficult, 5 = very easy). Reported descriptively.

Time frame
Immediately after audio exposure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute for Human Development and Potential (IHDP), Singapore

Lead sponsor

The University of Queensland

Collaborator

Charles University, Czech Republic

Collaborator

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