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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Jalisco
-
Potrerillos, Jalisco, México, 45815
- Under The Tree Potrerillos
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Behavioral Rigidity Index - Pondered (study-derived composite index)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRC-P-CTUT-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .