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Can Cognitive Training Decrease Reactive Aggression?

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ClinicalTrials.gov Identifier: NCT03623477
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : February 28, 2020
Sponsor:
Collaborators:
Brain & Behavior Research Foundation
National Center for Advancing Translational Science (NCATS)
Nathan Kline Institute for Psychiatric Research
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Cognitive Deficits Impulsive Aggression Emotion Impulsivity Behavioral: Cognitive Remediation (CRT) Behavioral: CRT+ Social Cognition Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control
Actual Study Start Date : August 16, 2016
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : October 25, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Cognitive Remediation (CRT)
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.
Behavioral: CRT+ Social Cognition Training
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. Change in Impulse Control [ Time Frame: Change from baseline in impulse control measures up to the end of intervention at 4 months ]
    Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623477


Locations
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United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035
NewYork Presbyterian Hospital
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Brain & Behavior Research Foundation
National Center for Advancing Translational Science (NCATS)
Nathan Kline Institute for Psychiatric Research
Investigators
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Principal Investigator: Anthony O Ahmed, PhD Weill Cornell Medicine
Principal Investigator: Jean-Pierre Lindenmayer, MD Manhattan Psychiatric Center
Principal Investigator: Matthew J Hoptman, PhD Nathan Kline Institute for Psychiatric Research
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03623477    
Other Study ID Numbers: 1505016194
UL1TR000457 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Cognitive Remediation
Social Cognition Training
Emotion Regulation
Urgency
Additional relevant MeSH terms:
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Schizophrenia
Aggression
Cognition Disorders
Cognitive Dysfunction
Impulsive Behavior
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Behavioral Symptoms
Neurocognitive Disorders