- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623477
Can Cognitive Training Decrease Reactive Aggression?
February 26, 2020 updated by: Weill Medical College of Cornell University
Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control
The purpose of the study is to examine the effects of cognitive training on emotion regulation, impulse control, and aggression in people with schizophrenia.
The study compares a combination of computerized cognitive remediation and social cognition training (CRT+SCT) to cognitive remediation alone (CRT).
Study outcomes include multiple measures of aggression, emotion regulation, impulse control, cognition, and symptoms.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Neurocognitive and social cognitive impairments are contributors to negative emotionality and impulsive aggression in people with schizophrenia.
Impulsive aggression poses several challenges to the care of people with schizophrenia.
These include a greater risk of rehospitalization and longer hospital stays, involvement with the criminal justice system, and increased risk of recidivism.
The investigators recently found that schizophrenia patients with aggression history experienced improvements in neurocognition as well as decreased hostility/agitation and incidents of verbal and physical aggression after participating in cognitive remediation training (CRT).
Based on these findings, it is hypothesized that improving neurocognition through CRT may have enhanced the capacity of schizophrenia patients to inhibit aggression through improved emotion regulation capacity and impulse control.
It is also postulated that the addition of Social Cognition Training (SCT) to CRT would provide greater benefits on emotion regulation and impulse control over CRT alone.
To test the hypotheses, the investigators will conduct a clinical trial that compares two configurations of cognitive training--CRT plus SCT versus CRT plus control computer games.
The goal of the study is to examine the comparative benefits of the two configurations of cognitive training on outcomes that include neurocognition, social cognition, emotion regulation, impulse control, and reactive aggression.
Participants assigned to the CRT plus SCT group will complete 24 hours of CRT and 12 hours of SCT.
Participants assigned to the CRT only group will complete 24 hours of CRT and 12 hours of control computer activities.
Emotion regulation, impulse control, and reactive aggression will be indexed using laboratory-based challenges.
The investigators will recruit and characterize 90 study participants on demographic and clinical variables including age, gender, education, aggression history, and medications.
Study outcome measures will be administered at baseline and posttreatment to participants randomized to the study groups.
In a subsample of 32 patients, the study investigators will further examine changes in the neural network of emotion regulation and impulsivity before and after cognitive training.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10035
- Manhattan Psychiatric Center
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White Plains, New York, United States, 10605
- NewYork Presbyterian Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of schizophrenia or schizo-affective disorder
- Age 18-60
- Mini Mental Status Exam score greater/equal to 24 at screening
- Auditory and visual acuity adequate to complete cognitive tests
- At least a score of 5 or more on the Life History of Aggression (LHA) aggression items or one confirmed assault in the past year
- Capacity and willingness to give consent
Exclusion Criteria:
- Inability to read or speak English
- Documented significant disease of the Central Nervous System (CNS)
- History of intellectual impairment predating psychosis (e.g., a diagnosis of developmental disability)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cognitive Remediation (CRT)
Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities.
|
Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training.
The cognitive remediation therapy group will complete computerized training activities in attention, memory, processing speed, problem solving, and executive functions.
|
Experimental: CRT+ Social Cognition Training
Participants assigned to the combination of CRT and SCT will complete 24 hours of computerized neurocognitive training in memory, attention, and processing speed, and 12 hours of computerized social cognition training focused on improving emotion recognition, social perspective taking, and mentalizing abilities.
|
Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training.
The combined cognitive remediation and social cognition training group will complete computerized training that target neurocognitive functions, facial affect emotion recognition and mentalizing tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Aggression
Time Frame: Change from baseline in aggression measures up to the end of intervention at 4 months
|
Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).
|
Change from baseline in aggression measures up to the end of intervention at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive outcomes
Time Frame: Change from baseline in cognition measures up to the end of intervention at 4 months
|
MATRICS Consensus Cognitive Battery (MCCB); Emotion Recognition-40 (ER-40); Reading the Mind in the Eyes (Eyes Task)
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Change from baseline in cognition measures up to the end of intervention at 4 months
|
Change in Emotionality
Time Frame: Change from baseline in emotionality measures up to the end of intervention at 4 months
|
Positive and Negative Affect Scale (PANAS); Toronto Alexithymia Scale (TAS); Observer Alexithymia Scale (OAS)
|
Change from baseline in emotionality measures up to the end of intervention at 4 months
|
Change in Emotion Regulation Capacity
Time Frame: Change from baseline in measures up to the end of intervention at 4 months
|
Picture viewing task completed while peripheral psychophysiological response is obtained
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Change from baseline in measures up to the end of intervention at 4 months
|
Change in Impulse Control
Time Frame: Change from baseline in impulse control measures up to the end of intervention at 4 months
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Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task
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Change from baseline in impulse control measures up to the end of intervention at 4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psychotic symptoms
Time Frame: Change from baseline in psychotic symptom measure up to the end of intervention at 4 months
|
Positive and Negative Syndrome Scale (PANSS).
Scale total scores range from 30 to 210 with higher scores indicating greater symptom severity
|
Change from baseline in psychotic symptom measure up to the end of intervention at 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anthony O Ahmed, PhD, Weill Medical College of Cornell University
- Principal Investigator: Matthew J Hoptman, PhD, Nathan Kline Institute for Psychiatric Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2016
Primary Completion (Actual)
October 25, 2019
Study Completion (Actual)
October 25, 2019
Study Registration Dates
First Submitted
August 3, 2017
First Submitted That Met QC Criteria
August 6, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1505016194
- UL1TR000457 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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