Brief Contextual-Behavioral vs Twelve-Step Intervention for Emotion Regulation in Substance Use: Pilot Study (MEX-BERA)

January 2, 2026 updated by: Lauro Gutiérrez Castro

Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors

This study evaluated the effectiveness of a brief behavioral-contextual intervention delivered through 11 weekly individual sessions (45 minutes each) to improve emotion regulation, distress tolerance, and psychological flexibility among adults undergoing residential rehabilitation for problematic substance use in a Mexican therapeutic community. The intervention combined functional analysis, Dialectical Behavior Therapy strategies adapted for substance use disorders, and Acceptance and Commitment Therapy techniques. Participants received structured materials, including a session manual, mindfulness audio recordings, worksheets, and adapted behavioral monitoring tools.

A quasi-experimental pretest-posttest design with matched allocation was used. The Treatment Group (n = 19) received the structured intervention, while the Comparison Group (n = 17) received usual residential care based on a 12-step model. Primary assessments were administered at baseline and seven weeks after baseline. Primary outcome measures included changes in total scores on the Difficulties in Emotion Regulation Scale (DERS) and the Distress Tolerance Scale (DTS). Secondary outcomes included psychological flexibility (AAQ-II), emotion regulation strategies (ERQ reappraisal and suppression subscales), and behavioral indicators such as craving logs and engagement in value-consistent activities.

Procedures to ensure implementation fidelity included a standardized intervention manual, periodic clinical supervision, and consistent documentation using structured forms. Due to practical constraints and a moderate sample size, the statistical plan relied on robust analytical strategies, including nonparametric tests, permutation-based ANCOVA, and bootstrap estimation to evaluate effect sizes and sensitivity. All participants provided written informed consent, and the protocol was approved by an institutional ethics committee. Individual-level data will not be publicly shared due to confidentiality requirements; methodological materials and analytic scripts may be made available upon request and under confidentiality agreement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study evaluated the effectiveness of a behavioral-contextual intervention, delivered in 11 weekly individual sessions (45 min each), aimed at improving emotion regulation, distress tolerance, and psychological flexibility among adults in residential rehabilitation for problematic substance use in a Mexican therapeutic community. The protocol combined functional analysis, DBT (SUD adaptations) and ACT techniques, practice materials (mindfulness audios, worksheets) and an adapted behavioral monitoring system. The design was quasi-experimental pre-post with a Treatment Group (TG; n = 19) and a Comparison Group (CG; n = 17) receiving usual care (12-step program). Primary measures were DERS, DTS, ERQ and AAQ-II administered at baseline and 7 weeks post-baseline. Implementation fidelity was supported by a manual, monthly supervision and standardized records. Analyses used robust methods (nonparametric tests, permutational ANCOVA, bootstrap, robust estimators).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Ajijic, Jalisco, Mexico, 45920
        • Comunidad Terapéutica Under The Tree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Resident of the participating therapeutic community undergoing treatment for problematic substance use or alcohol.
  • Capacity to provide informed consent and complete self-report assessments.

Exclusion Criteria:

  • Active psychosis or unstable psychiatric comorbidity that precludes participation.
  • Severe cognitive impairment preventing participation.
  • Refusal to participate or unavailability to complete baseline and post assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral-Contextual Emotion Regulation Program (BCERP)
Individual intervention comprising 11 weekly sessions (45 minutes each). The intervention combines functional ABC analysis, attentional focus training, crisis management skills (STOP protocol), distress tolerance training (DBT-SUD), mindfulness practices with behavioral anchoring, ACT techniques to enhance psychological flexibility, and consolidation exercises with relapse prevention.
Behavioral: Behavioral-Contextual Emotion Regulation Program (BCERP)
The Behavioral-Contextual Emotion Regulation Program (BCERP) is a structured emotional regulation skills training intervention based on Applied Behavior Analysis principles and adapted to a therapeutic community setting for individuals undergoing substance use rehabilitation. Unlike interventions focused solely on psychoeducation, BCERP integrates intensive skills practice, gradual exposure to high-distress situations, and real-time feedback provided by trained therapists. The program includes modules on distress tolerance, behavioral restructuring, functional identification of emotions, and the strengthening of alternative, non-substance-related behaviors. BCERP is distinguished by its emphasis on continuous supervision, the use of contextual therapeutic language, and systematic progress monitoring through weekly behavioral indicators.
Other Names:
  • Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors
  • BCERP for Substance Use Rehabilitation
No Intervention: Standard Residential Treatment Based on the Twelve-Step Facilitation Model
Standard therapeutic community residential program based on the 12-step model, without the structured sessions of the experimental protocol. Pre- and post-assessments applied at the same time points as the Treatment Group (TG).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difficulties in Emotion Regulation Scale (DERS-24 Total + Subscales)
Time Frame: Baseline to 7 weeks post-baseline
The Difficulties in Emotion Regulation Scale - 24 item version (DERS-24), validated in Mexican populations, is a self-report measure assessing emotion regulation difficulties. The total score and five subscales are analyzed: Emotional Rejection, Emotional Dyscontrol, Emotional Interference, Emotional Inattention, and Emotional Confusion. Higher scores indicate greater difficulties in emotion regulation (worse outcome). Changes in total and subscale scores from baseline to post-intervention will be analyzed as continuous outcomes. No validated clinical cut-off scores exist; exploratory cohort analyses, when conducted, will use pre-specified sample-based thresholds (e.g., median or tertiles).
Baseline to 7 weeks post-baseline
Distress Tolerance Scale (DTS) - Spanish Version
Time Frame: Baseline to 7 weeks post-baseline.
Change in Distress Tolerance Scale (DTS) subscale scores - Tolerance, Appraisal, Absorption, Regulation. Change (Post - Pre) in DTS subscale scores. Subscale scoring (sum of items): Tolerance (3-15; higher = greater tolerance), Appraisal (6-30; higher = greater tolerance), Absorption (3-15; higher = greater tolerance), Regulation (3-15; higher = greater tolerance). Item 6 is reverse-scored.
Baseline to 7 weeks post-baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal and Expressive Suppression Subscales
Time Frame: Baseline to 7 weeks.
The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report measure assessing habitual emotion regulation strategies. Two subscales are analyzed: Cognitive Reappraisal (6 items; score range 6-42), where higher scores indicate greater use of adaptive emotion regulation, and Expressive Suppression (4 items; score range 4-28), where higher scores indicate greater use of suppression, considered a less adaptive strategy. Primary analyses will examine continuous change in subscale scores from baseline to post-intervention. In secondary analyses, participants will be classified as responders or non-responders using a pre-specified cohort threshold defined as a change of at least 0.5 standard deviations from baseline (increase for reappraisal, decrease for suppression).
Baseline to 7 weeks.
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline to 7 weeks.
The Acceptance and Action Questionnaire-II (AAQ-II) is a 7-item self-report measure assessing psychological flexibility and experiential avoidance. Total scores range from 7 to 49, with higher scores indicating greater experiential avoidance and lower psychological flexibility (worse outcome). Primary analyses will examine continuous change in total AAQ-II scores from baseline to post-intervention. In secondary analyses, participants will be classified as responders or non-responders using a pre-specified cohort threshold defined as a decrease of at least 0.5 standard deviations from baseline, indicating a clinically meaningful increase in psychological flexibility.
Baseline to 7 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lauro Gutiérrez Castro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lauro Gutiérrez Castro, Comunidad Terapéutica Under The Tree

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTT-PSI-MEX-BERA-001-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If data sharing is conducted, only de-identified Individual Participant Data (IPD) will be made available, including coded demographic variables, baseline assessments, intervention adherence indicators, and pre-post outcome measures. No information that could directly or indirectly identify participants will be shared. Data will be provided exclusively for research purposes upon reasonable request and subject to a data-use agreement ensuring confidentiality and appropriate use. Study documentation such as manuals and analytic code may also be shared when relevant.

IPD Sharing Time Frame

IPD will be available only upon reasonable request from qualified researchers after completion of the primary analysis and publication of the study results. Availability will not include informed consent forms, as these documents are confidential and protected. The availability period will begin once the principal investigator receives a formal request and will remain open as long as there is a valid and ethically approved research purpose. All data will be provided in anonymized form and in full compliance with data protection regulations.

IPD Sharing Access Criteria

Access to IPD and supporting information will be restricted to qualified researchers affiliated with academic or clinical institutions capable of meeting ethical and regulatory standards. Access will be limited to anonymized data relevant to clearly defined scientific research purposes approved by an ethics committee. Formal requests must be submitted to the principal investigator, who will evaluate the scientific rationale and confidentiality safeguards. Upon approval, data will be shared through a secure transfer mechanism under a data-use agreement that prohibits any attempt at re-identification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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