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Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders

Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06981351
Acronym
MCT
Enrollment
288
Registered
2025-05-20
Start date
2025-03-18
Completion date
2029-05-31
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antisocial Behavior

Keywords

Cognitive skills training, Attention to Context, Affective Cognitive Control

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.

Interventions

BEHAVIORALAttention 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.

BEHAVIORALAffective 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.

Sponsors

The Mind Research Network
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Staff that conduct cognitive skills training sessions will be blinded to group assignment.

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Cognitive task performance - StroopFrom enrollment to end of treatment at six weeksStroop task. Performance is quantified by number of correct responses (0 - 100)%.
Cognitive task performance - Lexical Decision MakingFrom enrollment to end of treatment at six weeksLexical Decision Making task. Performance is quantified by number of correct responses (0 - 100%).
Cognitive task performance - Delay DiscountingFrom enrollment to end of treatment at six weeksDelay Discounting task. Performance is quantified quantified by calculating where the answers place the respondent amid reference discounting curves. Range 0.0-0.5.
Functional MRI - Go/NoGo task performanceChange assessed from enrollment to end of treatment at six weeksFunctional MRI task performance (Go/NoGo task). Performance is quantified by the number of 'false alarms' (responding to the NoGo stimulus). Range 0-39.
Functional MRI - Go/Nogo brain responseActivity assessed during MRI scan. Change assessed from enrollment to end of treatment at six weeksChange (i.e. increased or decreased) in functional brain response (Blood Oxygen Level Dependent/BOLD) in region of interest (anterior cingulate) assessed using Statistical Parametric Mapping (SPM).
Real-World Outcomes - Substance use (TLFB)From enrollment to six months post-release from incarcerationSubstance use. Assessed using the timeline follow back (TLFB) - calendar recording dates of use for stimulant drugs.
Real-World Outcomes - Substance use (ASE)From enrollment to six months post-release from incarcerationSubstance use. Assessed using the Abstinence Self Efficacy scale (higher scores indicate greater difficulty with abstinence). Range 0-4.
Real-World Outcomes - Substance use (DUDIT)From enrollment to six months post-release from incarcerationSubstance use. Assessed using the Drug Use Disorders Identification test (higher scores indicate more/severe substance use). Range 0-44.
Real-World Outcomes - Criminal behaviorFrom enrollment to six months post-release from incarcerationCriminal behavior. Assessed using the Crime Inventory - records the number of instances of criminal behavior
Risky Impulsive Self-Destructive BehaviorFrom enrollment to six months post-release from incarcerationThe RISQ questionnaire measures risky, impulsive, and self-destructive behaviors in 8 domains (aggression, self-harm, gambling, impulsive spending/driving, impulsive eating, risky sex, illegal behavior, and alcohol use). For each behavior, respondents note the number of times they have engaged in the behavior in their lifetime. Higher scores indicate more severe risky, impulsive, and self destructive behavior.

Countries

United States

Contacts

CONTACTCarla Harenski
charenski@mrn.org505-272-5028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026