- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590115
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Jalisco
-
Potrerillos, Jalisco, Mexico, 45815
- Under The Tree Potrerillos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Rigidity Index - Pondered (study-derived composite index)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRC-P-CTUT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on No intervention
-
Hopital FochNot yet recruitingInterstitial Lung DiseaseFrance
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
Huashan HospitalZhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Tongji Hospital; Qilu Hospital... and other collaboratorsRecruitingHead and Neck Squamous Cell Carcinoma | Patient Derived Organoid | Drug Sensitive Test in VitroChina
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of Dublin, Trinity CollegeCompleted