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NCT07590154

Cross-sectional Functional Stratification Based on Psychometric Profiling and Machine Learning in Patients With Substance Use Disorders (SUD)

Sponsor: Lauro Gutiérrez Castro

View on ClinicalTrials.gov

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 psychometric data and to explore whether those representations can help stratify clinical subpopulations. We 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.

Official title: Unsupervised Deep Representation Learning for Clinical Stratification in Substance Use Disorders

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

155

Start Date

2024-03-25

Completion Date

2026-04-22

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

Under The Tree

Ajijic, Jalisco, Mexico