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
- Are there results?
- None posted in the registry
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
- ClinicalTrials.gov ID
- NCT01428349
- Acronym / sponsor ID
- SE-2011-0103
- Conditions
- Psychopathy, Personality Disorders
- Keywords
- Incarcerated offenders, emotionally reactive, emotionally stable, psychopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention to Context | Experimental | Other: Cognitive Remediation |
| Affective Cognitive Control | Experimental | Other: Cognitive Remediation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male,
- ages 18-45 years,
- elevated scores of psychopathy or externalizing measures
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RemediationComputer 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. | Other | Attention to Context |
| Cognitive RemediationComputer 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. | Other | Affective Cognitive Control |
Primary outcome
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.
1 secondary outcome
Frequency of Conduct Reports
Time frame: within 3 months of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Results publication: PubMed 25977843Baskin-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P Newman, Ph.D. principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation in people with Psychopathy and Personality Disorders, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysiological change from pre-treatment to post-treatment (time frame: 6 weeks after pre-testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.