Substance Abuse DisorderSISAP-TUSNCT07590154
Cross-sectional Functional Stratification Based on Psychometric Profiling and Machine Learning in Patients With Substance Use Disorders (SUD)
An observational study of Substance Abuse Disorder and Addiction, run by Lauro Gutiérrez Castro at 1 site in Mexico.
Trial summary
Substance use disorders (SUDs) show considerable clinical heterogeneity that limits the usefulness of traditional categorical diagnoses. This observational, cross-sectional study aims to apply an unsupervised deep learning method - an autoencoder - to learn continuous latent representations from standardised… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Abuse Disorder, Addiction, Clinical Stratification
- How many people
- 155 participants
- Where
- 1 siteMexico
- Study dates
- 25 Mar 2024to 22 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients (≥18 years) with a diagnosis of Substance Use Disorder (SUD) admitted to a residential detoxification and rehabilitation center. Consecutive recruitment between February 2024 and March 2026. Estimated final sample size is 155 participants. No healthy volunteers are included.
Who may be able to join
- DSM-5 diagnosis of Substance Use Disorder (SUD), confirmed by a psychiatrist or clinical psychologist.
- Age ≥ 18 years.
- Currently admitted to a residential addiction treatment center at the time of assessment.
- Ability to complete the psychometric questionnaires independently.
- Written informed consent.
Who cannot join
- Active psychotic disorder (e.g., schizophrenia, delusional disorder) not stabilized pharmacologically.
- Severe cognitive impairment (dementia, severe brain injury) that prevents understanding the questionnaire items.
- Language barriers or illiteracy that prevent self-administration of the scales.
- Scheduled discharge from the center within 7 days of the assessment date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unsupervised Deep Representation Learning for Clinical Stratification in Substance Use Disorders
Substance use disorders (SUDs) show considerable clinical heterogeneity that limits the usefulness of traditional categorical diagnoses. This observational, cross-sectional study aims to apply an unsupervised deep learning method - an autoencoder - to learn continuous latent representations from standardised psychometric data and to explore whether those representations can help stratify clinical subpopulations. The investigators will recruit 155 adults undergoing residential treatment for SUD. Participants will complete six validated instruments assessing impulsivity (BIS-11), anger regulation (STAXI-2), behavioural activation/avoidance (BADS), borderline symptomatology (BSL-23), generalised anxiety (GAD-7), and environmental reward (EROS). Demographic and clinical variables (age, sex, primary substance, years of use, prior treatments) will also be recorded.
After data cleaning and standardisation (z-scores), a symmetric autoencoder with a 12-dimensional bottleneck (architecture 21-32-24-12-24-32-21) will be trained using mean squared error loss. Regularisation includes L2 weight decay and dropout. The model will be trained 30 times with different random seeds to assess stability; the five best models (by validation pseudo-R²) will be combined into a weighted ensemble. Five-fold cross-validation will evaluate generalisation. For comparison, principal component analysis (PCA) will be applied to the same data. Gaussian mixture models (GMM) will be fitted on the latent space to explore potential clinical subgroups.
Read more
The primary outcome is the stability of the latent representation (coefficient of variation of validation MSE across runs). Secondary outcomes include reconstruction performance (pseudo-R²) of the ensemble, comparison with PCA, and the interpretability of latent dimensions via correlations with original variables. GMM results will be described using BIC, silhouette width, bootstrap stability, and clinical characterisation of clusters.
This study does not involve any intervention. Results will be hypothesis-generating and require external validation. No automated clinical decisions will be made.
Read the detailed description
Substance use disorders (SUDs) are characterised by substantial heterogeneity in clinical presentation, behavioural patterns, emotional regulation difficulties, impulsivity, and treatment response. Individuals with the same categorical diagnosis may differ considerably in symptom severity, comorbid psychopathology, and psychosocial functioning. This variability limits the explanatory value of traditional diagnostic classifications and supports the development of dimensional and data-driven approaches for patient characterisation.
Recent advances in machine learning provide methods capable of identifying latent structures within complex clinical datasets. Autoencoders, a form of unsupervised deep learning, can learn compact nonlinear representations of multidimensional data while preserving relevant information from the original variables. Compared with traditional linear dimensionality reduction methods such as principal component analysis (PCA), autoencoders may better capture complex interactions among psychological and behavioural variables. When combined with probabilistic clustering approaches such as Gaussian mixture models (GMM), these latent representations may facilitate the identification of clinically meaningful patient subgroups.
The purpose of this observational study is to apply an autoencoder model to psychometric and clinical data obtained from adults receiving residential treatment for substance use disorders. The study aims to explore latent dimensions underlying symptom and behavioural variability and to evaluate whether these dimensions support stable subgroup identification.
Primary Objective:
To learn a 12-dimensional latent representation from standardised psychometric and clinical variables using an autoencoder model and evaluate the stability of this representation across repeated training procedures.
Secondary Objectives:
To compare the reconstruction performance of the autoencoder with principal component analysis (PCA).
To characterise the clinical meaning of the latent dimensions through correlations with the original variables.
To explore potential patient subgroups using Gaussian mixture models (GMM) applied to the latent space.
To assess the stability and interpretability of the identified subgroups.
Study Design:
This is a single-centre, observational, cross-sectional, non-interventional study conducted in a residential addiction treatment facility. Recruitment is planned from February 2024 through December 2025. The study is registered prior to dissemination of results.
Study Population:
Approximately 155 adults diagnosed with substance use disorder according to DSM-5 criteria will be included. Eligible participants must be 18 years of age or older, currently receiving residential treatment, capable of completing study questionnaires, and willing to provide written informed consent.
Participants with active psychotic disorders, severe cognitive impairment, significant language or literacy barriers, or imminent discharge from treatment will be excluded.
Measures and Data Collection:
Participants will complete a battery of validated self-report instruments assessing impulsivity, anger regulation, behavioural activation and avoidance, borderline symptomatology, anxiety, and environmental reward. Additional demographic and clinical variables will include age, sex, primary substance of use, years of substance use, and prior treatment history.
Questionnaires include:
Barratt Impulsiveness Scale (BIS-11) State-Trait Anger Expression Inventory-2 (STAXI-2) Behavioral Activation for Depression Scale (BADS) Borderline Symptom List-23 (BSL-23) Generalized Anxiety Disorder-7 (GAD-7) Environmental Reward Observation Scale (EROS)
Data Analysis:
Clinical variables will be standardised prior to analysis. Missing values are expected to be minimal and will be handled using median imputation procedures. Redundant variables with excessive multicollinearity may be removed before modelling.
An autoencoder neural network will be trained to generate a reduced latent representation of the clinical data. Model performance and stability will be evaluated across repeated training runs and cross-validation procedures. Reconstruction accuracy will be compared with PCA using equivalent dimensionality.
The resulting latent space will subsequently be analysed using Gaussian mixture models to explore potential patient subgroups. Model selection will consider statistical fit, cluster stability, and clinical interpretability. Correlations between latent dimensions and original clinical variables will be examined to facilitate interpretation of the learned representations.
Ethical Considerations:
The study protocol has been approved by the corresponding Institutional Ethics Committee. All participants will provide written informed consent prior to participation. Data will be anonymised after collection, and no direct identifiers will be retained.
This study is observational and will not modify routine clinical treatment. No automated clinical decisions will be made based on model outputs. Participants may experience mild emotional discomfort or fatigue while completing questionnaires; psychological support will be available if needed.
The study will be conducted in accordance with the Declaration of Helsinki and applicable local ethical regulations.
Dissemination:
Results will be submitted for publication in peer-reviewed scientific journals and presented at academic conferences. De-identified data and analysis code may be shared publicly after publication to support transparency and reproducibility.
- Conditions
- Substance Abuse Disorder, Addiction, Clinical Stratification, Substance-related Disorders, Residential Treatment Program
- Being tested
- No intervention (observational only)
- Keywords
- Transdiagnostic, Machine Learning, Psychometric Assessment, Dimensionality Reduction, RDoC
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational only)Other
This is a purely observational study. No drug, device, behavioral therapy, or other intervention was assigned. The study only involved standardized psychometric measurements.
| Study group | Role | What they receive |
|---|---|---|
| Total sample (residential treatment) | Adult patients (N=155) with DSM-5 TR substance use disorder receiving residential treatment. All participants completed six psychometric scales (BIS-11, STAXI-2, BADS, BSL-23, GAD-7, EROS) and provided demographic/clinical data in a single cross-sectional session. No intervention was administered. Receives: Other: No intervention (observational only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latent dimension scores
Twelve continuous latent dimensions derived from the bottleneck layer of a symmetric autoencoder trained on 21 standardized clinical variables. Each dimension represents a compressed, nonlinear combination of the original psychometric indicators (impulsivity, emotion regulation, behavioral activation, borderline symptoms, anxiety, and environmental reward). The dimensions are extracted for each participant after averaging the predictions of an ensemble of the five best autoencoder runs.
Unit of Measure: Standardized z-score (mean = 0, SD = 1 in the training sample)
Measured: Baseline (single assessment, cross-sectional)
Secondary outcomes (6)
Gaussian mixture model cluster membership
Categorical assignment of each participant to one of the clusters obtained by fitting a Gaussian mixture model with full covariance matrices to the 12-dimensional latent space. The number of clusters is determined by the Bayesian Information Criterion (BIC) and clinical interpretability. This outcome is exploratory and does not imply discrete subtypes.
Unit of Measure: Nominal (cluster number: 1, 2, …)
Measured: Baseline
Autoencoder reconstruction pseudo-R²
Proportion of variance in the original 21 clinical variables that is explained by the autoencoder's reconstructions, defined as 1 - (MSE_model / MSE_null), where MSE_null is the mean squared error of a model predicting only the mean. This metric is calculated for the ensemble of the five best models and for each of the 30 independent runs separately.
Unit of Measure: Proportion (range 0 to 1)
Measured: Baseline (computed on the validation split and on the full sample after training)
Autoencoder reconstruction mean squared error
Average squared difference between the original 21 standardized input variables and the reconstructed outputs produced by the autoencoder. Lower values indicate better reconstruction. Reported for the ensemble model and for each independent run.
Unit of Measure: Mean squared error (dimensionless, as data are z-standardized)
Measured: Baseline
Coefficient of variation of reconstruction MSE
Coefficient of variation (CV = standard deviation / mean) of the reconstruction MSE computed over 30 independent autoencoder training runs with different random seeds. This metric assesses the stability and reproducibility of the model.
Unit of Measure: Percentage (%)
Measured: Baseline (after all runs are completed)
Cross-validated reconstruction R²
Mean R² (and standard deviation) obtained from 5-fold cross-validation repeated 3 times, using the same autoencoder architecture and hyperparameters. This evaluates how well the model generalises to unseen patients.
Unit of Measure: Proportion (range 0 to 1)
Measured: Baseline
Explained variance by 12 principal components
Total proportion of variance explained by the first 12 principal components obtained from PCA applied to the same 21 standardized variables. This serves as a comparator for the autoencoder's reconstruction performance.
Unit of Measure: Proportion (range 0 to 1)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start25 Mar 2024
- Primary completion18 Feb 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Lauro Gutiérrez Castro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
- Investigators
- Lauro Gutiérrez Castro, Principal investigator, Under The Tree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590154
- Sponsor's protocol ID
- SISAP-TUS-EFTP-ML-2024
- Other IDs
- U1111-1346-9830
- Acronym
- SISAP-TUS
- Status last verified
- Sep 2026
- First submitted
- 9 May 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the manuscript will be shared after de-identification (anonymization). The data will include the 21 standardized clinical variables and the 12-dimensional latent representations for all 155 participants. Study protocol, statistical analysis plan, and R code will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unsupervised Deep Representation Learning for Clinical Stratification in Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07590154
- Acronym / sponsor ID
- SISAP-TUS / SISAP-TUS-EFTP-ML-2024
- Conditions
- Substance Abuse Disorder, Addiction, Clinical Stratification, Substance-related Disorders, Residential Treatment Program
- Keywords
- Transdiagnostic, Machine Learning, Psychometric Assessment, Dimensionality Reduction, RDoC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Lauro Gutiérrez CastroUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 15 May 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.
Substance use disorders (SUDs) show considerable clinical heterogeneity that limits the usefulness of traditional categorical diagnoses. This observational, cross-sectional study aims to apply an unsupervised deep learning method - an autoencoder - to learn continuous latent representations from standardised psychometric data and to explore whether those representations can help stratify clinical subpopulations. The investigators will recruit 155 adults undergoing residential treatment for SUD. Participants will complete six validated instruments assessing impulsivity (BIS-11), anger regulation (STAXI-2), behavioural activation/avoidance (BADS), borderline symptomatology (BSL-23), generalised anxiety (GAD-7), and environmental reward (EROS). Demographic and clinical variables (age, sex, primary substance, years of use, prior treatments) will also be recorded.
After data cleaning and standardisation (z-scores), a symmetric autoencoder with a 12-dimensional bottleneck (architecture 21-32-24-12-24-32-21) will be trained using mean squared error loss. Regularisation includes L2 weight decay and dropout. The model will be trained 30 times with different random seeds to assess stability; the five best models (by validation pseudo-R²) will be combined into a weighted ensemble. Five-fold cross-validation will evaluate generalisation. For comparison, principal component analysis (PCA) will be applied to the same data. Gaussian mixture models (GMM) will be fitted on the latent space to explore potential clinical subgroups.
The primary outcome is the stability of the latent representation (coefficient of variation of validation MSE across runs). Secondary outcomes include reconstruction performance (pseudo-R²) of the ensemble, comparison with PCA, and the interpretability of latent dimensions via correlations with original variables. GMM results will be described using BIC, silhouette width, bootstrap stability, and clinical characterisation of clusters.
This study does not involve any intervention. Results will be hypothesis-generating and require external validation. No automated clinical decisions will be made.
Detailed description
Substance use disorders (SUDs) are characterised by substantial heterogeneity in clinical presentation, behavioural patterns, emotional regulation difficulties, impulsivity, and treatment response. Individuals with the same categorical diagnosis may differ considerably in symptom severity, comorbid psychopathology, and psychosocial functioning. This variability limits the explanatory value of traditional diagnostic classifications and supports the development of dimensional and data-driven approaches for patient characterisation.
Recent advances in machine learning provide methods capable of identifying latent structures within complex clinical datasets. Autoencoders, a form of unsupervised deep learning, can learn compact nonlinear representations of multidimensional data while preserving relevant information from the original variables. Compared with traditional linear dimensionality reduction methods such as principal component analysis (PCA), autoencoders may better capture complex interactions among psychological and behavioural variables. When combined with probabilistic clustering approaches such as Gaussian mixture models (GMM), these latent representations may facilitate the identification of clinically meaningful patient subgroups.
The purpose of this observational study is to apply an autoencoder model to psychometric and clinical data obtained from adults receiving residential treatment for substance use disorders. The study aims to explore latent dimensions underlying symptom and behavioural variability and to evaluate whether these dimensions support stable subgroup identification.
Primary Objective:
To learn a 12-dimensional latent representation from standardised psychometric and clinical variables using an autoencoder model and evaluate the stability of this representation across repeated training procedures.
Secondary Objectives:
To compare the reconstruction performance of the autoencoder with principal component analysis (PCA).
To characterise the clinical meaning of the latent dimensions through correlations with the original variables.
To explore potential patient subgroups using Gaussian mixture models (GMM) applied to the latent space.
To assess the stability and interpretability of the identified subgroups.
Study Design:
This is a single-centre, observational, cross-sectional, non-interventional study conducted in a residential addiction treatment facility. Recruitment is planned from February 2024 through December 2025. The study is registered prior to dissemination of results.
Study Population:
Approximately 155 adults diagnosed with substance use disorder according to DSM-5 criteria will be included. Eligible participants must be 18 years of age or older, currently receiving residential treatment, capable of completing study questionnaires, and willing to provide written informed consent.
Participants with active psychotic disorders, severe cognitive impairment, significant language or literacy barriers, or imminent discharge from treatment will be excluded.
Measures and Data Collection:
Participants will complete a battery of validated self-report instruments assessing impulsivity, anger regulation, behavioural activation and avoidance, borderline symptomatology, anxiety, and environmental reward. Additional demographic and clinical variables will include age, sex, primary substance of use, years of substance use, and prior treatment history.
Questionnaires include:
Barratt Impulsiveness Scale (BIS-11) State-Trait Anger Expression Inventory-2 (STAXI-2) Behavioral Activation for Depression Scale (BADS) Borderline Symptom List-23 (BSL-23) Generalized Anxiety Disorder-7 (GAD-7) Environmental Reward Observation Scale (EROS)
Data Analysis:
Clinical variables will be standardised prior to analysis. Missing values are expected to be minimal and will be handled using median imputation procedures. Redundant variables with excessive multicollinearity may be removed before modelling.
An autoencoder neural network will be trained to generate a reduced latent representation of the clinical data. Model performance and stability will be evaluated across repeated training runs and cross-validation procedures. Reconstruction accuracy will be compared with PCA using equivalent dimensionality.
The resulting latent space will subsequently be analysed using Gaussian mixture models to explore potential patient subgroups. Model selection will consider statistical fit, cluster stability, and clinical interpretability. Correlations between latent dimensions and original clinical variables will be examined to facilitate interpretation of the learned representations.
Ethical Considerations:
The study protocol has been approved by the corresponding Institutional Ethics Committee. All participants will provide written informed consent prior to participation. Data will be anonymised after collection, and no direct identifiers will be retained.
This study is observational and will not modify routine clinical treatment. No automated clinical decisions will be made based on model outputs. Participants may experience mild emotional discomfort or fatigue while completing questionnaires; psychological support will be available if needed.
The study will be conducted in accordance with the Declaration of Helsinki and applicable local ethical regulations.
Dissemination:
Results will be submitted for publication in peer-reviewed scientific journals and presented at academic conferences. De-identified data and analysis code may be shared publicly after publication to support transparency and reproducibility.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total sample (residential treatment) | – | Other: No intervention (observational only)Adult patients (N=155) with DSM-5 TR substance use disorder receiving residential treatment. All participants completed six psychometric scales (BIS-11, STAXI-2, BADS, BSL-23, GAD-7, EROS) and provided demographic/clinical data in a single cross-sectional session. No intervention was administered. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients (≥18 years) with a diagnosis of Substance Use Disorder (SUD) admitted to a residential detoxification and rehabilitation center. Consecutive recruitment between February 2024 and March 2026. Estimated final sample size is 155 participants. No healthy volunteers are included.
Key inclusion criteria (5 listed)
- DSM-5 diagnosis of Substance Use Disorder (SUD), confirmed by a psychiatrist or clinical psychologist.
- Age ≥ 18 years.
- Currently admitted to a residential addiction treatment center at the time of assessment.
- Ability to complete the psychometric questionnaires independently.
- Written informed consent.
Key exclusion criteria (4 listed)
- Active psychotic disorder (e.g., schizophrenia, delusional disorder) not stabilized pharmacologically.
- Severe cognitive impairment (dementia, severe brain injury) that prevents understanding the questionnaire items.
- Language barriers or illiteracy that prevent self-administration of the scales.
- Scheduled discharge from the center within 7 days of the assessment date.
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 |
|---|---|---|
| No intervention (observational only)This is a purely observational study. No drug, device, behavioral therapy, or other intervention was assigned. The study only involved standardized psychometric measurements. | Other | Total sample (residential treatment) |
Primary outcome
Latent dimension scores
Time frame: Baseline (single assessment, cross-sectional)
Twelve continuous latent dimensions derived from the bottleneck layer of a symmetric autoencoder trained on 21 standardized clinical variables. Each dimension represents a compressed, nonlinear combination of the original psychometric indicators (impulsivity, emotion regulation, behavioral activation, borderline symptoms, anxiety, and environmental reward). The dimensions are extracted for each participant after averaging the predictions of an ensemble of the five best autoencoder runs. Unit of Measure: Standardized z-score (mean = 0, SD = 1 in the training sample)
6 secondary outcomes
Gaussian mixture model cluster membership
Time frame: Baseline
Autoencoder reconstruction pseudo-R²
Time frame: Baseline (computed on the validation split and on the full sample after training)
Autoencoder reconstruction mean squared error
Time frame: Baseline
Coefficient of variation of reconstruction MSE
Time frame: Baseline (after all runs are completed)
Cross-validated reconstruction R²
Time frame: Baseline
Explained variance by 12 principal components
Time frame: Baseline
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the manuscript will be shared after de-identification (anonymization). The data will include the 21 standardized clinical variables and the 12-dimensional latent representations for all 155 participants. Study protocol, statistical analysis plan, and R code will also be made available.
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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.
Lauro Gutiérrez Castro principal investigator
Under The Tree
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse Disorder and Addiction, run by Lauro Gutiérrez Castro at 1 site in Mexico.
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 5 inclusion and 4 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 2 Oct 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 Mexico. 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?
Latent dimension scores (time frame: Baseline (single assessment, cross-sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.