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

NCT07337733 | Completed

• 1 other identifier: UTT-PSI-MEX-BERA-001-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Emotional Dysregulation; Distress Intolerance; Drug Use Disorder; Substance Use Disorders

Keywords

Emotion Regulation; Distress Tolerance; Substance Use Disorder; Behavioral Intervention; Psychological Flexibility

Outcome Measures

Primary Outcomes (2)

• Difficulties in Emotion Regulation Scale (DERS-24 Total + Subscales)

  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

  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 Outcomes (2)

• Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal and Expressive Suppression Subscales

  Baseline to 7 weeks.

• Acceptance and Action Questionnaire-II (AAQ-II)

  Baseline to 7 weeks.

Study Arms (2)

Behavioral-Contextual Emotion Regulation Program (BCERP)

EXPERIMENTAL

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)

Standard Residential Treatment Based on the Twelve-Step Facilitation Model

NO INTERVENTION

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).

Interventions

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.

Also known as: Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors, BCERP for Substance Use Rehabilitation

Behavioral-Contextual Emotion Regulation Program (BCERP)

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lauro Gutiérrez Castro: lead

Study Sites (1)

Comunidad Terapéutica Under The Tree

Ajijic, Jalisco, 45920, Mexico

Location

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism; Emotional Regulation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Lauro Gutiérrez Castro

  Comunidad Terapéutica Under The Tree

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study used a quasi-experimental, parallel-group design with matched allocation. Participants were assigned either to the Treatment Group, which received an 11-session behavioral-contextual intervention focused on emotion regulation and distress tolerance, or to the Comparison Group, which received usual residential care based on a 12-step model. Assessments were conducted at baseline and seven weeks later. The model emphasizes ecological validity within a therapeutic community setting, individual delivery of the intervention, and standardized procedures to ensure fidelity across sessions.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 13, 2026
• Study Start: June 18, 2024
• Primary Completion: October 9, 2025
• Study Completion: November 26, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

ME (1)