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Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders (MCT)

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The Mind Research Network

Status

Enrolling

Conditions

Antisocial Behavior

Treatments

Behavioral: Attention to Context (ATC) training
Behavioral: Affective Cognitive Control (ACC) training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06981351
R01DA058004 (U.S. NIH Grant/Contract)
24615

Details and patient eligibility

About

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.

Full 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.

Enrollment

288 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

288 participants in 3 patient groups

Attention to context deficit
Experimental group
Description:
Participants with attention to context deficits will receive treatment either targeted towards their specific deficit (matched) or towards affective cognitive control deficits (mismatched).
Treatment:
Behavioral: Affective Cognitive Control (ACC) training
Behavioral: Attention to Context (ATC) training
Affective Cognitive Control deficit
Experimental group
Description:
Participants with affective cognitive control deficits will receive treatment either targeted towards their specific deficit (matched) or towards attention to context deficits (mismatched).
Treatment:
Behavioral: Affective Cognitive Control (ACC) training
Behavioral: Attention to Context (ATC) training
No psychopathology
Experimental group
Description:
Participants in the no psychopathology group will receive one of the two treatment types (ATC or ACC).
Treatment:
Behavioral: Affective Cognitive Control (ACC) training
Behavioral: Attention to Context (ATC) training

Trial contacts and locations

1

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Central trial contact

Carla Harenski

Data sourced from clinicaltrials.gov

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