PsychopathyNCT01428349
Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
A study testing Cognitive Remediation in people with Psychopathy and Personality Disorders, run by University of Wisconsin, Madison at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Psychopathy, Personality Disorders
- What is being tested?
- Cognitive Remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to May 2013
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male,
- ages 18-45 years,
- elevated scores of psychopathy or externalizing measures
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fox Lake Correctional Institution
Fox Lake, Wisconsin, 53933
Oshkosh Correctional Institution
Oshkosh, Wisconsin, 54901
About this study
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.
- Conditions
- Psychopathy, Personality Disorders
- Being tested
- Cognitive Remediation
- Keywords
- Incarcerated offenders, emotionally reactive, emotionally stable, psychopathy
- Medical subject headings
- Antisocial Personality Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Cognitive RemediationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention to Context | Experimental | Not described Receives: Other: Cognitive Remediation |
| Affective Cognitive Control | Experimental | Not described Receives: Other: Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after pre-testing
Secondary outcomes (1)
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.
Measured: within 3 months of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph P Newman, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428349
- Sponsor's protocol ID
- SE-2011-0103
- Status last verified
- Nov 2011
- First submitted
- 17 Aug 2011
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25977843