NCT01428349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 2, 2015

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

August 17, 2011

Last Update Submit

May 29, 2015

Conditions

PsychopathyPersonality Disorders

Keywords

Incarcerated offendersemotionally reactiveemotionally stablepsychopathy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Frequency of Conduct Reports

    within 3 months of participation

Study Arms (2)

Attention to Context

EXPERIMENTAL
Other: Cognitive Remediation

Affective Cognitive Control

EXPERIMENTAL
Other: Cognitive Remediation

Interventions

Cognitive RemediationOTHER

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.

Attention to Context

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fox Lake Correctional Institution

Fox Lake, Wisconsin, 53933, United States

Location

Oshkosh Correctional Institution

Oshkosh, Wisconsin, 54901, United States

Location

Related 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. doi: 10.1177/2167702614560744.

    PMID: 25977843RESULT

MeSH Terms

Conditions

Antisocial Personality DisorderPersonality Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joseph P Newman, Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

September 5, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 2, 2015

Record last verified: 2011-11

Locations

US(2)