Clinical trial NCT06981351: Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders
Official title: Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antisocial Behavior
Keywords: Cognitive skills training
Attention to Context
Affective Cognitive Control
Lead sponsor: The Mind Research Network
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-20
Enrollment: 288
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-

Primary outcomes:
measure: Cognitive task performance - Stroop
timeFrame: From enrollment to end of treatment at six weeks
measure: Cognitive task performance - Lexical Decision Making
timeFrame: From enrollment to end of treatment at six weeks
measure: Cognitive task performance - Delay Discounting
timeFrame: From enrollment to end of treatment at six weeks
measure: Functional MRI - Go/NoGo task performance
timeFrame: Change assessed from enrollment to end of treatment at six weeks
measure: Functional MRI - Go/Nogo brain response
timeFrame: Activity assessed during MRI scan. Change assessed from enrollment to end of treatment at six weeks
measure: Real-World Outcomes - Substance use (TLFB)
timeFrame: From enrollment to six months post-release from incarceration
measure: Real-World Outcomes - Substance use (ASE)
timeFrame: From enrollment to six months post-release from incarceration
measure: Real-World Outcomes - Substance use (DUDIT)
timeFrame: From enrollment to six months post-release from incarceration
measure: Real-World Outcomes - Criminal behavior
timeFrame: From enrollment to six months post-release from incarceration
measure: Risky Impulsive Self-Destructive Behavior
timeFrame: From enrollment to six months post-release from incarceration
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Mind Research Network/Lovelace Biomedical Research Institute
state: New Mexico
Study officials:
References: