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Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

Primary Purpose

Psychopathy, Personality Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Cognitive Remediation
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychopathy focused on measuring Incarcerated offenders, emotionally reactive, emotionally stable, psychopathy

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Lake Correctional Institution
  • Oshkosh Correctional Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Attention to Context

Affective Cognitive Control

Arm Description

Outcomes

Primary Outcome Measures

Psychophysiological change from pre-treatment to post-treatment
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
Assess change in the frequency of institution conduct reports post-treatment. We will compare frequency of these reports pre-treatment and post-treatment.

Full Information

First Posted
August 17, 2011
Last Updated
May 29, 2015
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01428349
Brief Title
Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
Official Title
Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychopathy, Personality Disorders
Keywords
Incarcerated offenders, emotionally reactive, emotionally stable, psychopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention to Context
Arm Type
Experimental
Arm Title
Affective Cognitive Control
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychophysiological change from pre-treatment to post-treatment
Description
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.
Time Frame
6 weeks after pre-testing
Secondary Outcome Measure Information:
Title
Frequency of Conduct Reports
Description
Assess change in the frequency of institution conduct reports post-treatment. We will compare frequency of these reports pre-treatment and post-treatment.
Time Frame
within 3 months of participation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Newman, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Lake Correctional Institution
City
Fox Lake
State/Province
Wisconsin
ZIP/Postal Code
53933
Country
United States
Facility Name
Oshkosh Correctional Institution
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25977843
Citation
Baskin-Sommers AR, Curtin JJ, Newman JP. Altering the Cognitive-Affective Dysfunctions of Psychopathic and Externalizing Offender Subtypes with Cognitive Remediation. Clin Psychol Sci. 2015 Jan 1;3(1):45-57. doi: 10.1177/2167702614560744.
Results Reference
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Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

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