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Substance Use Disorder (SUD)DYNA-NLPNCT07595614

NLP Analysis of Weekly Narratives for Dynamic Clinical Assessment in SUD

An observational study of Substance Use Disorder (SUD) and Addiction, run by Lauro Gutiérrez Castro at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective observational study follows adults undergoing residential rehabilitation for severe substance use disorders at a specialized treatment center in Mexico. Participants provide weekly written narratives describing their emotions, challenges, coping strategies, and treatment experiences, and complete… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Substance Use Disorder (SUD), Addiction, Anxiety
What is being tested?
Residential rehabilitation as usual
How many people
35 participants
Where
1 siteMexico
Study dates
25 May 2025to Sep 2026
How long will I take part?
20 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult males (≥18 years) with severe substance use disorder, residing in a single residential rehabilitation center in Mexico. Participants are enrolled consecutively as they enter the program and meet eligibility criteria. The sample is non-probabilistic, reflecting the real-world clinical population of this specific center.

Who may be able to join

  • Clinical diagnosis of severe substance use disorder (polydrug use, including cocaine, methamphetamines, alcohol, and/or cannabis), confirmed by the center's admission assessment.
  • Male sex (all participants in the center's residential program are male).
  • Age 18 years or older.
  • Current resident of the participating residential rehabilitation center in Mexico.
  • Completed at least four weeks of residential treatment at the time of study enrollment.
  • Able to write coherent weekly narratives in Spanish (no severe cognitive impairment or active psychosis).
  • Willing to provide written informed consent.

Who cannot join

  • Presence of acute psychotic symptoms that interfere with the ability to write or understand the study procedures.
  • Severe cognitive impairment (e.g., due to traumatic brain injury, intellectual disability) that prevents meaningful narrative production.
  • Inability to comply with weekly narrative writing (e.g., illiteracy, severe visual impairment).
  • Planned discharge from the residential program within less than 4 weeks from enrollment.
  • Enrollment in another interventional clinical trial that could confound the interpretation of outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lauro Gutiérrez Castro contact

+523314696107

saraqael_sefer@hotmail.com

Ricardo Fernandez contact

+52 1 33 1544 5474

Mexico1 site, 1 recruiting
  • Under The Tree Potrerillos

    Potrerillos, Jalisco, 45815

    Lauro Gutiérrez Castro, +523314696107, saraqael_sefer@hotmail.com

    Recruiting

Other trials in Mexico

About this study

Official title: Analysis of Weekly Narratives Using Natural Language Processing in Patients Undergoing Residential Rehabilitation: A Hybrid Approach for the Dynamic Assessment of Clinical Processes

This prospective observational study follows adults undergoing residential rehabilitation for severe substance use disorders at a specialized treatment center in Mexico. Participants provide weekly written narratives describing their emotions, challenges, coping strategies, and treatment experiences, and complete validated psychological questionnaires every two weeks, including the Generalized Anxiety Disorder-7 (GAD-7), Environmental Reward Observation Scale (EROS), Automatic Thoughts Questionnaire-8 (ATQ-8), and Behavioral Activation for Depression Scale (BADS).

The study applies natural language processing (NLP) and machine learning methods to analyze participants' narratives and identify emotional, cognitive, and behavioral patterns associated with clinical change over time. Narrative-derived features are combined with questionnaire scores to generate a dynamic clinical risk representation that may help detect early signs of psychological worsening or improvement during residential treatment.

Participants continue receiving standard residential care, and the study does not modify treatment decisions or clinical interventions. Up to 35 participants with sufficient longitudinal follow-up data will be included in the primary analysis. Data collection is expected to continue through September 2026.

Read the detailed description

Patients undergoing treatment for substance use disorders frequently describe changes in mood, motivation, hopelessness, cognitive rigidity, emotional distress, and coping strategies through spontaneous written language. These narratives may contain clinically meaningful indicators associated with psychological deterioration, treatment progress, or relapse vulnerability. However, systematic manual analysis of longitudinal written narratives is difficult to implement in routine clinical practice because of the volume and complexity of the data.

Recent developments in natural language processing (NLP), representation learning, and deep learning provide methods for extracting quantitative linguistic and semantic information from written text. Integrating these features with repeated psychometric assessments may support the development of longitudinal models capable of characterizing changes in mental health status over time in patients receiving residential addiction treatment.

Objectives

The objectives of this study are:

To extract semantic, emotional, and linguistic features from weekly patient narratives using NLP methods, including sentence embeddings, sentiment and emotion classification, and semantic similarity analyses based on Acceptance and Commitment Therapy (ACT) constructs.

To integrate narrative-derived variables with repeated psychometric measures (Generalized Anxiety Disorder-7 (GAD-7), Environmental Reward Observation Scale (EROS), Automatic Thoughts Questionnaire-8 (ATQ-8), and Behavioral Activation for Depression Scale (BADS)) using a multimodal deep learning autoencoder capable of generating a low-dimensional representation of longitudinal clinical status.

To evaluate whether latent representations generated by the autoencoder are associated with periods of clinical worsening or clinical improvement across time using leave-one-patient-out cross-validation procedures.

To develop a dynamic longitudinal risk representation capable of estimating future changes in automatic negative thoughts, measured through subsequent ATQ-8 scores.

Study Design

This study is a prospective observational cohort conducted at a single residential rehabilitation center in Mexico.

Eligible participants are adults aged 18 years or older with a diagnosis of severe substance use disorder who are admitted for residential treatment. Individuals with active psychotic symptoms or cognitive impairment that substantially interferes with the ability to complete written narratives are excluded.

Participants complete:

Weekly digital written narratives using open-ended prompts focused on emotions, challenges, coping responses, interpersonal experiences, and perceived treatment progress.

Biweekly administration of the following validated self-report instruments:

GAD-7

EROS

ATQ-8

BADS

All information is collected through digital forms integrated into routine clinical monitoring procedures at the treatment center.

Participants may contribute data for up to 20 weeks, depending on duration of residential stay. The study began on 25 May 2025, and primary completion is anticipated in September 2026.

Up to 35 participants with sufficient longitudinal observations will be included in the primary analytic cohort.

NLP and Machine Learning Pipeline

Text preprocessing

Narratives are written in Spanish and undergo preprocessing procedures that include:

minimum length filtering, normalization, consolidation of narrative fields into a single weekly text sample, tokenization and linguistic annotation.

Feature extraction

Narrative features include:

Sentiment classification (positive, neutral, negative) Emotion probabilities for joy, sadness, anger, fear, surprise, and disgust using the pysentimiento library

Linguistic variables including:

type-token ratio, mean sentence length, proportion of first-person pronouns, proportion of past-tense verbs, obtained through udpipe

Semantic similarity measures between patient narratives and ACT-related prototype domains including:

experiential avoidance, cognitive fusion, rule-governed behavior, helplessness, achievement orientation, hopefulness

Semantic similarity is computed through cosine similarity between sentence-transformer embeddings and predefined prototype centroids.

Dimensionality reduction procedures using principal component analysis (PCA) are applied to selected linguistic and semantic variables to derive a principal component representing orientation toward internal emotional experience versus external contextual events.

Autoencoder Architecture

The multimodal model receives concatenated longitudinal feature vectors after robust scaling.

The architecture includes:

a bidirectional long short-term memory (BiLSTM) encoder, multi-head attention mechanisms, variational regularization using a β-variational autoencoder (β-VAE) framework, a decoder trained to reconstruct the original temporal feature sequence, and an auxiliary classification component predicting next-period clinical worsening.

The training objective combines:

mean squared reconstruction error, focal loss for classification, Kullback-Leibler divergence, and optional temporal smoothness regularization.

Model performance is evaluated using leave-one-patient-out cross-validation procedures. A final model may subsequently be trained using the complete dataset.

Primary Analyses

Primary analyses include:

evaluation of discriminative performance for prediction of subsequent clinical worsening using: area under the receiver operating characteristic curve (AUROC), area under the precision-recall curve (AUPRC), F1 score, Matthews correlation coefficient (MCC) examination of associations between latent trajectory representations and longitudinal psychometric changes, development of a Composite Clinical Risk Index (CCRI) derived from latent representations, and comparison of CCRI trajectories with weeks classified as clinical worsening according to predefined multimodal criteria.

Ethics and Dissemination

The study has received approval from the institutional review board of Under The Tree Miller A.C.

All participants provide written informed consent prior to participation.

Participation does not alter or replace standard residential treatment. All clinical decisions remain under the responsibility of treating professionals independent of study procedures.

Study findings will be submitted for publication in peer-reviewed scientific journals regardless of outcome. De-identified datasets and analysis code may be made available upon reasonable request and in accordance with institutional and ethical requirements.

Recruitment Status

Recruitment is ongoing. Final data collection for the primary outcome is anticipated in September 2026.

Being tested
Residential rehabilitation as usual
Keywords
Natural Language Processing, Machine Learning, Behavioral Activation, Automatic Thoughts, Residential Rehabilitation
Medical subject headings
Substance-Related Disorders, Behavior, Addictive, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Residential rehabilitation as usualOther

    Participants follow the standard residential rehabilitation program provided by the center. This is a naturalistic exposure; the study does not impose any additional intervention. The "intervention" of interest is the routine therapeutic environment and its associated psychological processes (e.g., changes in avoidance, cognitive fusion, hope, and behavioral activation). These processes are measured through weekly written narratives and biweekly validated clinical scales (GAD-7, EROS, ATQ-8, BADS).

Study groups in NCT07595614
Study groupRoleWhat they receive
Residential rehabilitation cohortAdult men (≥18 years) with severe substance use disorder, admitted to a residential rehabilitation center in Mexico. All participants receive the center's standard, multimodal treatment program, which includes group therapy, individual counseling, occupational activities, 12-step facilitation, and relapse prevention education. The study does not assign, modify, or withhold any component of this program. Participants are followed prospectively for the duration of their stay (10-20 weeks).
Receives: Other: Residential rehabilitation as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version

    The Automatic Thoughts Questionnaire 8-item version is administered every two weeks. Total scores range from 8 to 40, with higher scores indicating more frequent negative automatic thoughts. The primary outcome is the change from baseline in total score over the course of residential treatment.

    Measured: Every 2 weeks from baseline until discharge from residential treatment (up to 20 weeks)

Secondary outcomes (5)
  1. Change in generalized anxiety symptoms measured by the Generalized Anxiety Disorder 7 item scale

    The Generalized Anxiety Disorder 7-item scale is administered every two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.

    Measured: Every 2 weeks from baseline until discharge (up to 20 weeks)

  2. Change in environmental reward measured by the Environmental Reward Observation Scale

    The Environmental Reward Observation Scale iis administered every two weeks. Total scores range from 10 to 40, with higher scores indicating greater exposure to positive environmental reinforcement.

    Measured: Every 2 weeks from baseline until discharge (up to 20 weeks)

  3. Change in behavioral activation and avoidance measured by the Behavioral Activation for Depression Scale

    The Behavioral Activation for Depression Scale is administered every two weeks. Higher scores on the Activation subscale indicate greater engagement in goal-directed activity; higher scores on the Avoidance/Rumination subscale indicate greater behavioral avoidance and rumination.

    Measured: Every 2 weeks from baseline until discharge (up to 20 weeks)

  4. Weekly self-reported emotional intensity

    Participants report the intensity of their predominant weekly emotion on a 0 to 10 numeric rating scale, where higher scores indicate greater emotional intensity.

    Measured: Weekly from baseline until discharge (up to 20 weeks)

  5. Weekly self-reported craving intensity

    Participants rate average craving for substance use during the prior week on a 0 to 10 numeric rating scale, where higher scores indicate greater craving intensity.

    Measured: Weekly from baseline until discharge (up to 20 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start25 May 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
35 participants (estimated)
Target duration
20 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595614
Sponsor's protocol ID
SISAP-TUS-HYB/WN-01
Acronym
DYNA-NLP
Status last verified
May 2026
First submitted
9 May 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) from the weekly narratives and biweekly clinical scales, after removal of all direct identifiers (name, date of birth, exact dates converted to study day/week numbers). Only aggregated or pseudonymized data will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Substance Use Disorder (SUD) 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 May 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauro Gutiérrez Castro (+523314696107, saraqael_sefer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version (time frame: Every 2 weeks from baseline until discharge from residential treatment (up to 20 weeks)). 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 19 May 2026.

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