- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337733
Brief Contextual-Behavioral vs Twelve-Step Intervention for Emotion Regulation in Substance Use: Pilot Study (MEX-BERA)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jalisco
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Ajijic, Jalisco, Mexico, 45920
- Comunidad Terapéutica Under The Tree
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
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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
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.
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Baseline to 7 weeks post-baseline.
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Secondary Outcome Measures
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).
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Baseline to 7 weeks.
|
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Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline to 7 weeks.
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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.
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Baseline to 7 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauro Gutiérrez Castro, Comunidad Terapéutica Under The Tree
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTT-PSI-MEX-BERA-001-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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