Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:35 PM
Study NCT ID:
NCT07337733
Status:
COMPLETED
Last Update Posted:
2026-01-13
First Post:
2025-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Contextual-Behavioral vs Twelve-Step Intervention for Emotion Regulation in Substance Use: Pilot Study
Sponsor:
Lauro Gutiérrez Castro
Organization:
Study Overview
Official Title:
Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEX-BERA
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: