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Completed

NCT Number: NCT07337733

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

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.

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Key information

Conditions

Substance Use Disorders Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Distress Intolerance Drug Use Disorder Emotional Dysregulation Emotional Regulation Mental Disorders Self-Control Social Behavior Substance-Related Disorders

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comunidad Terapéutica Under The Tree

Ajijic, Jalisco, 45920, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral-Contextual Emotion Regulation Program (BCERP)

Behavioral

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

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Lauro Gutiérrez Castro

Other

Registry information

Official study title

Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors

Acronym: MEX-BERA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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