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Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

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ClinicalTrials.gov Identifier: NCT01428349
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Psychopathy Personality Disorders Other: Cognitive Remediation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
Study Start Date : May 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Psychophysiological change from pre-treatment to post-treatment [ Time Frame: 6 weeks after pre-testing ]
    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 :
  1. Frequency of Conduct Reports [ Time Frame: within 3 months of participation ]
    Assess change in the frequency of institution conduct reports post-treatment. We will compare frequency of these reports pre-treatment and post-treatment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428349


Locations
United States, Wisconsin
Fox Lake Correctional Institution
Fox Lake, Wisconsin, United States, 53933
Oshkosh Correctional Institution
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

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01428349     History of Changes
Other Study ID Numbers: SE-2011-0103
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: November 2011

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

Additional relevant MeSH terms:
Personality Disorders
Cognition Disorders
Cognitive Dysfunction
Antisocial Personality Disorder
Mental Disorders
Neurocognitive Disorders