MindfulnessSOMA-VALNCT07556744
SOMA Validation RCT: Testing Structural Equivalence and Mechanistic Orthogonality of an Open-Source Mindfulness Stimulus Library
A study testing SOMA Audio-Guided Mental Training Exercise in people with Mindfulness and Healthy Volunteers, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Healthy Volunteers
- What is being tested?
- SOMA Audio-Guided Mental Training Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSingapore
- Study dates
- 5 May 2026to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Standardized Open-source Mindfulness Architecture (SOMA): A Modular, Equity-Engineered Stimulus Library for Mechanistic Mindfulness Research
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.
Read more
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).
Read the detailed description
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.
- Conditions
- Mindfulness, Healthy Volunteers
- Being tested
- SOMA Audio-Guided Mental Training Exercise
- Keywords
- Mindfulness, Active Control, Stimulus Library, Mechanistic Research, Open Science, Socioeconomic Status, Credibility, Expectancy, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMA Audio-Guided Mental Training ExerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SOMA Audio-Guided Mental Training Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Immediately after audio exposure (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 May 2026
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland, Charles University, Czech Republic
- Responsible party
- Principal investigator, Alessandro Sparacio, Institute for Human Development and Potential (IHDP), Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556744
- Sponsor's protocol ID
- ASTAR-IHDP-2025-108-SOMA-VAL
- Other IDs
- osf.io/m76cg, 2025-108
- Acronym
- SOMA-VAL
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be shared in a public repository (Open Science Framework, osf.io/m76cg) after study completion and publication. The dataset will include all survey responses (excluding any inadvertently identifying information) and the analysis code needed to reproduce all reported results. Data sharing is a pre-specified condition of participation and is disclosed in the participant information sheet.
Publications
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.
PubMed 40828581Sparacio 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.
PubMed 38862815Devilly 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.
PubMed 11132119Tanay 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.
PubMed 24059475
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Standardized Open-source Mindfulness Architecture (SOMA): A Modular, Equity-Engineered Stimulus Library for Mechanistic Mindfulness Research
- ClinicalTrials.gov ID
- NCT07556744
- Acronym / sponsor ID
- SOMA-VAL / ASTAR-IHDP-2025-108-SOMA-VAL
- Conditions
- Mindfulness, Healthy Volunteers
- Keywords
- Mindfulness, Active Control, Stimulus Library, Mechanistic Research, Open Science, Socioeconomic Status, Credibility, Expectancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- The University of Queensland, Charles University, Czech Republic
- Study start
- 5 May 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Condition | Experimental | Behavioral: SOMA Audio-Guided Mental Training ExerciseParticipants 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. |
| Active Control Condition | Active comparator | Behavioral: SOMA Audio-Guided Mental Training ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOMA Audio-Guided Mental Training ExerciseA 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). | Behavioural | Active Control Condition, Mindfulness Condition |
Primary outcome
Credibility/Expectancy Questionnaire (CEQ) composite score
Time frame: Immediately after audio exposure (single time point)
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).
Mechanistic Double Dissociation: State Mindfulness Scale and Analytical Engagement Scale Interaction Score
Time frame: Immediately after audio exposure (single time point)
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.
1 secondary outcome
Semantic Differential scale
Time frame: Immediately after audio exposure (single time point)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 40828581Sparacio 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.
- Background: PubMed 38862815Sparacio 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.
- Background: PubMed 11132119Devilly 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.
- Background: PubMed 24059475Tanay 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.
- The OSF page of the project with all the relevant study documentation.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified participant-level data will be shared in a public repository (Open Science Framework, osf.io/m76cg) after study completion and publication. The dataset will include all survey responses (excluding any inadvertently identifying information) and the analysis code needed to reproduce all reported results. Data sharing is a pre-specified condition of participation and is disclosed in the participant information sheet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOMA Audio-Guided Mental Training Exercise in people with Mindfulness and Healthy Volunteers, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Credibility/Expectancy Questionnaire (CEQ) composite score (time frame: Immediately after audio exposure (single time point)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07556744, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.