Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders

Обзор

The goal of this clinical trial is to investigate the effect of two types of cognitive remediation training on real-world behavioral outcomes including substance use, institutional adjustment, and recidivism following release from prison. Each training type is designed to target one of two subtypes of antisocial criminal offenders, who are characterized by either: 1) Attention to context-based deficits, or 2) Affective cognitive control-based deficits. The main questions it aims to answer are: Does matching deficit type with targeted cognitive training improve outcomes (relative to mismatched training)? What are the functional brain mechanisms that underlie treatment change? Participants will: Be assigned to cognitive training that either does or does not match their deficit type. Complete six one-hour sessions of cognitive skills training. Complete pre and post-training behavioral tasks assessing self-regulation deficits. Complete structural MRI scans and functional MRI scans assessing cognitive control. Complete post-treatment follow-up assessments evaluating self-regulation, adjustment, and stressful life events, substance use and recidivism.

Подробное описание

Prior research has identified two subtypes of antisocial offenders, typified by distinct dysfunctional cognitive emotion interactions undermining self-regulation. One subtype is characterized by an attention-based abnormality, which impairs adaptive processing of contextual information, tangential to one's primary focus. This abnormality is typified by offenders with high levels of callous/unemotional traits. A second subtype is characterized by hyper-reactions to personally relevant cues, interfering with executive functions that are otherwise needed to regulate behavior. This abnormality is prevalent in those with high externalizing characteristics. The investigators have developed cognitive skills training that addresses each of these specific deficits in distinct ways. These distinct interventions are intended to address mechanism-specific cognitive emotional dysfunction, as opposed to treating distinct dysfunctions with a uniform approach. The investigators' NIH-funded pilot work has shown evidence of improving outcomes in offenders by matching specific deficits with focused skills training. This project will execute a well-powered, randomized clinical trial to demonstrate reliability and generalizability of these effects. We expect to verify prior findings of improved outcomes by matching individual deficits with the targeted interventions. Effects of treatment on specific cognitive skills (assessed by laboratory-based tests) and real-world behavioral outcomes including substance use behaviors, institutional adjustment, and recidivism following release from prison will be examined. Further, advanced neuroimaging measures will be used to assess brain changes with treatment. This will aid in specifying potentially different mechanisms of treatment success in each respective group. This project addresses the ongoing need to improve and validate focused interventions that target specific deficits, replacing less-effective one-size-fits-all approaches.

Вмешательства

• Поведенческое Attention to Context (ATC) training
  ATC training focuses on learning to attend to and integrate contextual cues present in the environment. Three tasks, Reversal Learning, Divided Visual Field, and Affective Gaze, require ATC functioning and provide individuals with practice noticing changes in contextual information, such as rule changes and using emotion information to modulate behavior.
• Поведенческое Affective Cognitive Control (ACC) training
  ACC training focuses on providing individuals with practice inhibiting behavior, particularly within motivational or affective contexts. Three tasks, Shapes, Numbers, and Lottery, tap ACC functioning and place demands on the basic employment of cognitive control, such as task switching, as well as on the concurrent engagement of cognitive control and affective processing.

Первичные конечные точки

• Cognitive task performance - Stroop [Срок оценки: From enrollment to end of treatment at six weeks]
• Cognitive task performance - Lexical Decision Making [Срок оценки: From enrollment to end of treatment at six weeks]
• Cognitive task performance - Delay Discounting [Срок оценки: From enrollment to end of treatment at six weeks]
• Functional MRI - Go/NoGo task performance [Срок оценки: Change assessed from enrollment to end of treatment at six weeks]
• Functional MRI - Go/Nogo brain response [Срок оценки: Activity assessed during MRI scan. Change assessed from enrollment to end of treatment at six weeks]
• Real-World Outcomes - Substance use (TLFB) [Срок оценки: From enrollment to six months post-release from incarceration]
• Real-World Outcomes - Substance use (ASE) [Срок оценки: From enrollment to six months post-release from incarceration]
• Real-World Outcomes - Substance use (DUDIT) [Срок оценки: From enrollment to six months post-release from incarceration]
• Real-World Outcomes - Criminal behavior [Срок оценки: From enrollment to six months post-release from incarceration]
• Risky Impulsive Self-Destructive Behavior [Срок оценки: From enrollment to six months post-release from incarceration]

Критерии участия

Критерии включения

• Currently incarcerated
• No uncorrectable auditory or visual deficits
• Able to speak and/or understand English
• 5th grade reading level or higher
• IQ score = 80 or above
• Lifetime history of substance use disorder based on DSM criteria
• No history of dementia or other cognitive disability
• No indication of current psychotic disorder
• No major medical illness or CNS disease
• Scores from the Psychopathy Checklist-Revised (PCL-R) meet criteria for one of the designated treatment groups

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mind Research Network/Lovelace Biomedical Research Institute — Albuquerque

Идентификаторы

NCT: NCT06981351 · 24615 · R01DA058004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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