NLP Analysis of Weekly Narratives for Dynamic Clinical Assessment in SUD

NCT07595614 | Recruiting

• 1 other identifier: SISAP-TUS-HYB/WN-01
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Substance Use Disorder (SUD); Emotional Dysregulation; Addiction; Anxiety; Rumination - Thoughts

Keywords

Natural Language Processing; Machine Learning; Behavioral Activation; Automatic Thoughts; Residential Rehabilitation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Change in generalized anxiety symptoms measured by the Generalized Anxiety Disorder 7 item scale

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

• Change in environmental reward measured by the Environmental Reward Observation Scale

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

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

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

• Weekly self-reported emotional intensity

  Weekly from baseline until discharge (up to 20 weeks)

• Weekly self-reported craving intensity

  Weekly from baseline until discharge (up to 20 weeks)

Other Outcomes (4)

• Narrative sentiment valence index derived from weekly written narratives

  Weekly from baseline until discharge (up to 20 weeks)

• Semantic similarity to Acceptance and Commitment Therapy-related constructs

  Weekly from baseline until discharge (up to 20 weeks)

• Composite Clinical Risk Index derived from longitudinal narrative features

  Weekly from baseline until discharge (up to 20 weeks)

Study Arms (1)

Residential rehabilitation cohort

Adult 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).

Other: Residential rehabilitation as usual

Interventions

Residential rehabilitation as usual OTHER

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).

Residential rehabilitation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lauro Gutiérrez Castro: lead

Study Sites (1)

Under The Tree Potrerillos

Potrerillos, Jalisco, 45815, Mexico

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Lauro Gutiérrez Castro

  Under The Tree

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauro Gutiérrez Castro

CONTACT

+523314696107; saraqael_sefer@hotmail.com

Ricardo Fernandez

CONTACT

+52 1 33 1544 5474

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start: May 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available starting 6 months after publication of the primary results and will remain available for 5 years.
• Access Criteria: Data will be shared upon reasonable request to the corresponding author. Requesters must sign a data use agreement that prohibits re-identification and restricts use to replicating the published analyses or conducting secondary analyses approved by the study's ethics committee. De-identified data will be provided in CSV format; analytic code will be provided as R and Python scripts via a public repository (e.g., GitHub).

Locations

ME (1)