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临床试验/NCT07337733
NCT07337733已完成不适用

Behavioral-Contextual Intervention for Emotional Regulation in Addictive Behaviors

Lauro Gutiérrez Castro1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年6月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Difficulties in Emotion Regulation Scale (DERS-24 Total + Subscales)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Behavioral-Contextual Emotion Regulation Program (BCERP) (Behavioral)

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).

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Lauro Gutiérrez Castro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lauro Gutiérrez Castro

Principal Investigator

Under The Tree Therapeutic Community

研究点 (1)

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