Clinical Trial

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

Study acronym: MEX-BERA
Completed
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Summary
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.
Trial Details
NCT Number NCT07337733
Lead Sponsor Lauro Gutiérrez Castro
Conditions Substance Use Disorders, Drug Use Disorder, Alcohol Use Disorder, Emotional Dysregulation, Distress Intolerance
Enrollment 36 participants
Start Date 2024-06-18
Primary Completion 2025-10-09 (estimated)
Study Completion 2025-11-26 (estimated)
Updated on ClinicalTrials.gov 2026-01-13