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

14. května 2026 aktualizováno: Lauro Gutiérrez Castro

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

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.

Přehled studie

Postavení

Zápis na pozvánku

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

35

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Jalisco
      • Potrerillos, Jalisco, Mexiko, 45815
        • Under The Tree Potrerillos

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Adult patients (age 18-60) with substance use disorder and co-occurring emotional dysregulation or behavioral maladaptation, admitted to a residential therapeutic community in Mexico. The sample includes both sexes, with an expected predominance of males (approximately 85%). Participants are receiving standard psychosocial treatment, including individual and group therapy, 12-step facilitation, and occupational activities. No healthy volunteers are included.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Behavioral Rigidity Index - Pondered (study-derived composite index)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. května 2025

Primární dokončení (Aktuální)

15. dubna 2026

Dokončení studie (Odhadovaný)

1. července 2026

Termíny zápisu do studia

První předloženo

9. května 2026

První předloženo, které splnilo kritéria kontroly kvality

9. května 2026

První zveřejněno (Aktuální)

15. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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