Substance Use Disorder (SUD)RIG-TDNCT07590115
Behavioral Rigidity in Residential Treatment for Substance Use Disorder (RIG-TD)
An observational study of Substance Use Disorder (SUD) and Anxiety, run by Lauro Gutiérrez Castro at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Use Disorder (SUD), Anxiety, Depression Anxiety Disorder
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 25 May 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Behavioral rigidity, Substance use disorder, Transdiagnostic, Longitudinal, NLP, Absolutism, Bayesian multilevel, Therapeutic community
- Medical subject headings
- Substance-Related Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in negative automatic thoughts measured by the Automatic Thoughts Questionnaire 8-item version
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.
Measured: Weekly from baseline until discharge from treatment (up to 12 weeks)
Secondary outcomes (5)
Behavioral Rigidity Index - Pondered (study-derived composite index)
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.
Measured: Weekly from baseline until discharge (up to 12 weeks)
Behavioral activation measured by the Behavioral Activation for Depression Scale Activation subscale
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.
Measured: Weekly from baseline until discharge (up to 12 weeks)
Avoidance and rumination measured by the Behavioral Activation for Depression Scale Avoidance/Rumination subscale
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.
Measured: Weekly from baseline until discharge (up to 12 weeks)
Linguistic Rigidity Index derived from therapy session transcripts
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.
Measured: Weekly from baseline until discharge (up to 12 weeks)
Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7-item scale
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.
Measured: Weekly from baseline until discharge (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start25 May 2025
- Primary completion15 Apr 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lauro Gutiérrez Castro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
- Investigators
- Lauro Gutiérrez Castro, Principal investigator, Under The Tree Therapeutic Community
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590115
- Sponsor's protocol ID
- IRC-P-CTUT-001
- Acronym
- RIG-TD
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Rigidity as a Transdiagnostic Dynamic Process in Patients With Substance Use Disorders: A Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT07590115
- Acronym / sponsor ID
- RIG-TD / IRC-P-CTUT-001
- Keywords
- Behavioral rigidity, Substance use disorder, Transdiagnostic, Longitudinal, NLP, Absolutism, Bayesian multilevel, Therapeutic community
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Lauro Gutiérrez CastroUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Substance Use Disorder | – | Other: No interventionAdult 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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. | Other | Participants with Substance Use Disorder |
Primary outcome
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.
5 secondary outcomes
Behavioral Rigidity Index - Pondered (study-derived composite index)
Time frame: 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)
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)
Linguistic Rigidity Index derived from therapy session transcripts
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauro Gutiérrez Castro principal investigator
Under The Tree Therapeutic Community
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorder (SUD) and Anxiety, run by Lauro Gutiérrez Castro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.