Substance Use DisordersMEX-BERANCT07337733
Brief Contextual-Behavioral vs Twelve-Step Intervention for Emotion Regulation in Substance Use: Pilot Study
A study testing Behavioral-Contextual Emotion Regulation Program (BCERP) in people with Substance Use Disorders and Drug Use Disorder, run by Lauro Gutiérrez Castro at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Drug Use Disorder, Alcohol Use Disorder
- What is being tested?
- Behavioral-Contextual Emotion Regulation Program (BCERP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 18 Jun 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Substance Use Disorders, Drug Use Disorder, Alcohol Use Disorder, Emotional Dysregulation, Distress Intolerance
- Being tested
- Behavioral-Contextual Emotion Regulation Program (BCERP)
- Keywords
- Emotion Regulation, Distress Tolerance, Substance Use Disorder, Behavioral Intervention, Psychological Flexibility
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral-Contextual Emotion Regulation Program (BCERP)Behavioural
Also called Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors, BCERP for Substance Use Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline to 7 weeks post-baseline.
Secondary outcomes (2)
Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal and Expressive Suppression Subscales
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).
Measured: Baseline to 7 weeks.
Acceptance and Action Questionnaire-II (AAQ-II)
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.
Measured: Baseline to 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start18 Jun 2024
- Primary completion9 Oct 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauro Gutiérrez Castro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
- Investigators
- Lauro Gutiérrez Castro, Principal investigator, Comunidad Terapéutica Under The Tree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337733
- Sponsor's protocol ID
- UTT-PSI-MEX-BERA-001-2024
- Acronym
- MEX-BERA
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors
- ClinicalTrials.gov ID
- NCT07337733
- Acronym / sponsor ID
- MEX-BERA / UTT-PSI-MEX-BERA-001-2024
- Conditions
- Substance Use Disorders, Drug Use Disorder, Alcohol Use Disorder, Emotional Dysregulation, Distress Intolerance
- Keywords
- Emotion Regulation, Distress Tolerance, Substance Use Disorder, Behavioral Intervention, Psychological Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lauro Gutiérrez CastroUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavioral-Contextual Emotion Regulation Program (BCERP) | Experimental | Behavioral: 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. |
| 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). |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral-Contextual Emotion Regulation Program (BCERP)Also: Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors, BCERP for Substance Use RehabilitationThe 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. | Behavioural | Behavioral-Contextual Emotion Regulation Program (BCERP) |
Primary outcome
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).
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.
2 secondary outcomes
Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal and Expressive Suppression Subscales
Time frame: Baseline to 7 weeks.
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: Baseline to 7 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauro Gutiérrez Castro principal investigator
Comunidad Terapéutica Under The Tree
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral-Contextual Emotion Regulation Program (BCERP) in people with Substance Use Disorders and Drug Use Disorder, run by Lauro Gutiérrez Castro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale (DERS-24 Total + Subscales) (time frame: Baseline to 7 weeks post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.