Behavioral Rigidity in Residential Treatment for Substance Use Disorder (RIG-TD) (RIG-TD)
Behavioral Rigidity as a Transdiagnostic Dynamic Process in Patients With Substance Use Disorders: A Longitudinal Observational Study
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
This is an observational, longitudinal intensive study with repeated measures (weekly assessments) conducted in a residential therapeutic community in Mexico. Participants are adults (N=34, age 18-60) with substance use disorder and co-occurring emotional dysregulation or behavioral maladaptation, receiving standard psychosocial treatment (not assigned by the research protocol). Inclusion requires a minimum stay of four weeks, at least three complete measurement time points, and ability to complete self-reports. Exclusion criteria: severe neurocognitive impairment, acute psychotic symptoms, or incomplete longitudinal records.
Measures are collected at the beginning of each weekly therapy session:
Automatic Thoughts Questionnaire-8 (ATQ-8): frequency of negative automatic thoughts (higher scores indicate more frequent negative automatic thoughts).
Behavioral Activation for Depression Scale (BADS): subscales of Activation (goal-directed activity) and Avoidance/Rumination (experiential avoidance).
From these, a Behavioral Rigidity Index (BRI) is computed in two versions:
BRI-Simple (BRI-S): sum of standardized intraindividual scores of ATQ-8 + BADS-Avoidance - BADS-Activation.
BRI-Pondered (BRI-P): weighted combination derived from principal component analysis of the three standardized scores. The first principal component explained the majority of the common variance, supporting unidimensionality of the construct.
Additionally, natural language processing (NLP) pipelines are applied to transcribed therapy sessions and self-registries. Text is tokenized, lemmatized, and normalized by document length. Four linguistic domains are extracted:
Affective polarity: density of negative/positive terms.
Linguistic absolutism: frequency of extreme quantifiers (e.g., "always", "never", "everything", "nothing").
Grammatical agency: proportion of active vs. passive voice sentences.
Lexical complexity: type-token ratio and entropy.
A Linguistic Rigidity Index (LRI) is created by standardizing and averaging absolutism scores and inverted negative polarity (higher LRI = greater linguistic rigidity).
Statistical analysis uses Bayesian multilevel models with random intercepts by participant. The outcome variable is intraindividual standardized ATQ-8 (ATQ8_total_z). Predictors include time in treatment, BRI (contemporary and lagged by one week), and LRI. Model comparison will be performed using information criteria appropriate for multilevel models. Secondary analyses explore dynamic systems metrics derived from the state space defined by ATQ-8 and BRI-P, such as deviation from typical states and return speed after disturbances.
All procedures comply with the Declaration of Helsinki. The protocol was approved by the institutional ethics committee (Comité de Ética en Investigación de la Comunidad Terapéutica Under The Tree). Participants gave informed consent for anonymized use of their clinical data for research purposes.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
-
-
Jalisco
-
Potrerillos, Jalisco, Messico, 45815
- Under The Tree Potrerillos
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Minimum stay of four weeks in the residential treatment program
- At least three complete longitudinal measurement time points
- Ability to read, understand, and respond to self-report instruments in Spanish
- Capacity to participate in structured clinical sessions
- Diagnosis of substance use disorder (clinical assessment)
Exclusion Criteria:
- Severe neurocognitive impairment
- Acute psychotic symptoms
- Incomplete longitudinal records (less than three time points)
- Inability to complete self-report measures due to cognitive or language barriers
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Participants with Substance Use Disorder
Adult patients (n=34) receiving standard residential treatment for substance use disorder in a therapeutic community.
All participants undergo weekly assessments of cognitive reactivity (Automatic Thoughts Questionnaire-8 item version, ATQ-8), behavioral activation (Behavioral Activation for Depression Scale, BADS), and natural language processing (NLP) of therapy session transcripts.
|
This is an observational study; no experimental intervention is administered.
Participants continue their standard residential treatment as usual, which includes psychosocial therapy, 12-step facilitation, and occupational activities.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version
Lasso di tempo: Weekly from baseline until discharge from treatment (up to 12 weeks)
|
The Automatic Thoughts Questionnaire 8-item version is a self-report measure assessing the frequency of negative automatic thoughts.
Total scores range from 8 to 40, with higher scores indicating more frequent negative automatic thoughts.
Longitudinal change in total score across treatment is evaluated as the primary outcome.
|
Weekly from baseline until discharge from treatment (up to 12 weeks)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Behavioral Rigidity Index - Pondered (study-derived composite index)
Lasso di tempo: Weekly from baseline until discharge (up to 12 weeks)
|
Study-derived composite index calculated from standardized longitudinal measures of negative automatic thoughts, behavioral activation, and avoidance/rumination. Higher scores indicate greater behavioral and cognitive rigidity across time.
|
Weekly from baseline until discharge (up to 12 weeks)
|
|
Behavioral activation measured by the Behavioral Activation for Depression Scale Activation subscale
Lasso di tempo: Weekly from baseline until discharge (up to 12 weeks)
|
The Activation subscale of the Behavioral Activation for Depression Scale assesses engagement in goal-directed activity and environmental reinforcement.
Higher scores indicate greater behavioral activation.
|
Weekly from baseline until discharge (up to 12 weeks)
|
|
Avoidance and rumination measured by the Behavioral Activation for Depression Scale Avoidance/Rumination subscale
Lasso di tempo: Weekly from baseline until discharge (up to 12 weeks)
|
The Avoidance/Rumination subscale of the Behavioral Activation for Depression Scale assesses experiential avoidance and rumination-related behaviors.
Higher scores indicate greater avoidance and rumination.
|
Weekly from baseline until discharge (up to 12 weeks)
|
|
Linguistic Rigidity Index derived from therapy session transcripts
Lasso di tempo: Weekly from baseline until discharge (up to 12 weeks)
|
Study-derived linguistic index calculated from automated natural language processing of therapy session transcripts, including frequencies of absolutist language and negative affective polarity.
Higher scores indicate greater linguistic rigidity.
|
Weekly from baseline until discharge (up to 12 weeks)
|
|
Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7-item scale
Lasso di tempo: Weekly from baseline until discharge (up to 12 weeks)
|
The Generalized Anxiety Disorder 7-item scale assesses severity of anxiety symptoms.
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
|
Weekly from baseline until discharge (up to 12 weeks)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRC-P-CTUT-001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .