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

Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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 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)
- 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 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
- 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
- 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

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

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
United States, New York | |
Manhattan Psychiatric Center | |
New York, New York, United States, 10035 | |
NewYork Presbyterian Hospital | |
White Plains, New York, United States, 10605 |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cognitive Remediation Social Cognition Training Emotion Regulation Urgency |
Schizophrenia Aggression Cognition Disorders Cognitive Dysfunction Impulsive Behavior |
Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Behavioral Symptoms Neurocognitive Disorders |