Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

Personality Disorders Clinical Trial

Official title:

Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428349
• Other study ID #: SE-2011-0103
• Status: Completed
• Phase: N/A
• First received: August 17, 2011
• Last updated: May 29, 2015
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antisocial Personality Disorder
• Cognition Disorders
• Personality Disorders
• Psychopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fox Lake Correctional Institution	Fox Lake	Wisconsin
United States	Oshkosh Correctional Institution	Oshkosh	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks after pre-testing	No
Secondary	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.	within 3 months of participation	No