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Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

This study is currently recruiting participants.
Verified November 2011 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01428349
First received: August 17, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez) that examines whether recent progress in characterizing the cognitive deficits associated with psychopathic and externalizing offenders may be used to develop better therapeutic interventions to treat their substance abuse and other self-control problems. Inmates with externalizing or psychopathy will receive one of two computer-based interventions to remediate the core cognitive skills that have been linked to self-regulation deficits in the two groups. One intervention (ACC) targets the affective cognitive control deficits associated with externalizing offenders whereas the other intervention (ATC) targets the attention to context deficits associated with psychopathic offenders. The specific components of the project include: selection and randomization of inmates; pre- and post-treatment behavioral and brain-related (ERP and Startle) measures to evaluate the impact and specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g. computerized) and verbal training in ACC or ATC.


Condition Intervention
Reactive Psychopathy
Psychopathy, Emotionally Stable
Personality Disorders
 Other: Cognitive Remediation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Psychophysiological change from pre-treatment to post-treatment [ Time Frame: 6 weeks after pre-testing ] [ Designated as safety issue: No ]
    We will measure electrophysiology (EEG), startle responses (EMG measured in microvolts), and behavioral responses on six tasks that measure such processes as affective regulation, distress tolerance, cognitive control, selective attention, and attending to context.


Secondary Outcome Measures:
  • Frequency of Conduct Reports [ Time Frame: within 3 months of participation ] [ Designated as safety issue: No ]
    Assess change in the frequency of institution conduct reports post-treatment. We will compare frequency of these reports pre-treatment and post-treatment.


Estimated Enrollment: 192
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention to Context Other: Cognitive Remediation
Computer training on 3 tasks that targets the attention to context deficits associated with psychopathic offenders. Participants complete 6 training sessions, that include the tasks, feedback and real-world translational examples.
Experimental: Affective Cognitive Control Other: Cognitive Remediation
Computer training on 3 tasks that targets the affective cognitive control deficits associated with externalizing offenders. Participants complete 6 training sessions, that include the tasks, feedback and real-world translational examples.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male,
  • ages 18-45 years,
  • elevated scores of psychopathy or externalizing measures

Exclusion Criteria:

  • currently taking psychotropic medication,
  • below a 4th grade reading level,
  • history or current learning disability,
  • history of head trauma with lasting effects,
  • current diagnosis of PTSD,
  • Bipolar, or
  • psychosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428349

Contacts
Contact: Joseph P Newman, Ph.D. 608-262-3810 jpnewman@wisc.edu

Locations
United States, Wisconsin
Fox Lake Correctional Institution Recruiting
Fox Lake, Wisconsin, United States, 53933
Oshkosh Correctional Institution Not yet recruiting
Oshkosh, Wisconsin, United States, 54901
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joseph P Newman, Ph.D. University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01428349     History of Changes
Other Study ID Numbers: SE-2011-0103
Study First Received: August 17, 2011
Last Updated: November 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Incarcerated offenders
emotionally reactive
emotionally stable
psychopathy

Additional relevant MeSH terms:
Antisocial Personality Disorder
Personality Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013