Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders

NCT06981351 | Recruiting DMC

• 2 other identifiers: 24615R01DA058004
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Antisocial Behavior

Keywords

Cognitive skills training; Attention to Context; Affective Cognitive Control

Outcome Measures

Primary Outcomes (10)

• Cognitive task performance - Stroop

  Stroop task. Performance is quantified by number of correct responses (0 - 100)%.

  From enrollment to end of treatment at six weeks

• Cognitive task performance - Lexical Decision Making

  Lexical Decision Making task. Performance is quantified by number of correct responses (0 - 100%).

  From enrollment to end of treatment at six weeks

• Cognitive task performance - Delay Discounting

  Delay Discounting task. Performance is quantified quantified by calculating where the answers place the respondent amid reference discounting curves. Range 0.0-0.5.

  From enrollment to end of treatment at six weeks

• Functional MRI - Go/NoGo task performance

  Functional MRI task performance (Go/NoGo task). Performance is quantified by the number of 'false alarms' (responding to the NoGo stimulus). Range 0-39.

  Change assessed from enrollment to end of treatment at six weeks

• Functional MRI - Go/Nogo brain response

  Change (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).

  Activity assessed during MRI scan. Change assessed from enrollment to end of treatment at six weeks

• Real-World Outcomes - Substance use (TLFB)

  Substance use. Assessed using the timeline follow back (TLFB) - calendar recording dates of use for stimulant drugs.

  From enrollment to six months post-release from incarceration

• Real-World Outcomes - Substance use (ASE)

  Substance use. Assessed using the Abstinence Self Efficacy scale (higher scores indicate greater difficulty with abstinence). Range 0-4.

  From enrollment to six months post-release from incarceration

• Real-World Outcomes - Substance use (DUDIT)

  Substance use. Assessed using the Drug Use Disorders Identification test (higher scores indicate more/severe substance use). Range 0-44.

  From enrollment to six months post-release from incarceration

• Real-World Outcomes - Criminal behavior

  Criminal behavior. Assessed using the Crime Inventory - records the number of instances of criminal behavior

  From enrollment to six months post-release from incarceration

• Risky Impulsive Self-Destructive Behavior

  The 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.

  From enrollment to six months post-release from incarceration

Study Arms (3)

Attention to context deficit

EXPERIMENTAL

Participants with attention to context deficits will receive treatment either targeted towards their specific deficit (matched) or towards affective cognitive control deficits (mismatched).

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

Affective Cognitive Control deficit

EXPERIMENTAL

Participants with affective cognitive control deficits will receive treatment either targeted towards their specific deficit (matched) or towards attention to context deficits (mismatched).

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

No psychopathology

EXPERIMENTAL

Participants in the no psychopathology group will receive one of the two treatment types (ATC or ACC).

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

Interventions

Attention to Context (ATC) training BEHAVIORAL

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.

Affective Cognitive Control deficit; Attention to context deficit; No psychopathology

Affective Cognitive Control (ACC) training BEHAVIORAL

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.

Affective Cognitive Control deficit; Attention to context deficit; No psychopathology

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Biological sex at birth is male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Currently incarcerated
• No uncorrectable auditory or visual deficits
• Able to speak and/or understand English
• th 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

Sponsors & Collaborators

• The Mind Research Network: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Mind Research Network/Lovelace Biomedical Research Institute

Albuquerque, New Mexico, 87106, United States

RECRUITING

MeSH Terms

Conditions

Antisocial Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Carla Harenski

CONTACT

505-272-5028; charenski@mrn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Staff that conduct cognitive skills training sessions will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 20, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 20, 2025

Record last verified: 2025-04

Locations

US (1)