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Набор по приглашению NCT07590115

Behavioral Rigidity in Residential Treatment for Substance Use Disorder (RIG-TD)

Наблюдательное Substance Use Disorder (SUD) Anxiety Depression Anxiety Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Substance Use Disorder (SUD), Anxiety, Depression Anxiety Disorder. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Behavioral Rigidity as a Transdiagnostic Dynamic Process in Patients With Substance Use Disorders: A Longitudinal Observational Study

Обзор

Behavioral rigidity, the tendency to maintain inflexible patterns of thinking and acting despite changing circumstances, is a common feature in substance use disorders, depression, and anxiety. This observational study aims to measure behavioral rigidity as a dynamic, transdiagnostic process in patients undergoing residential treatment for substance use. Using a longitudinal intensive repeated-measures design, participants complete weekly assessments of cognitive reactivity (Automatic Thoughts Questionnaire-8 item version, ATQ-8), behavioral activation (Behavioral Activation for Depression Scale, BADS), and experiential avoidance. A Behavioral Rigidity Index (BRI) is derived from these measures. Additionally, natural language processing (NLP) is applied to therapy session transcripts to quantify linguistic absolutism (e.g., use of words like "always," "never") and affective polarity. Bayesian multilevel models examine whether rigidity predicts current and next-week clinical status. The study also explores whether linguistic markers add unique predictive value beyond self-reports. Results may inform personalized monitoring and interventions targeting psychological inflexibility in addiction treatment.

Подробное описание

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.

Вмешательства

  • Другое No intervention
    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.

Первичные конечные точки

  • Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version [Срок оценки: Weekly from baseline until discharge from treatment (up to 12 weeks)]
Вторичные конечные точки (5)
  • Behavioral Rigidity Index - Pondered (study-derived composite index) [Срок оценки: Weekly from baseline until discharge (up to 12 weeks)]
  • Behavioral activation measured by the Behavioral Activation for Depression Scale Activation subscale [Срок оценки: Weekly from baseline until discharge (up to 12 weeks)]
  • Avoidance and rumination measured by the Behavioral Activation for Depression Scale Avoidance/Rumination subscale [Срок оценки: Weekly from baseline until discharge (up to 12 weeks)]
  • Linguistic Rigidity Index derived from therapy session transcripts [Срок оценки: Weekly from baseline until discharge (up to 12 weeks)]
  • Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7-item scale [Срок оценки: Weekly from baseline until discharge (up to 12 weeks)]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Мексика · 1 центр
  • Under The Tree Potrerillos — Potrerillos

Идентификаторы

NCT: NCT07590115 · IRC-P-CTUT-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗