Clinical trial NCT03623477: Can Cognitive Training Decrease Reactive Aggression?
Official title: Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Cognitive Deficits
Impulsive Aggression
Emotion
Impulsivity
Keywords: Cognitive Remediation
Social Cognition Training
Emotion Regulation
Urgency
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
name: National Center for Advancing Translational Sciences (NCATS)
name: Nathan Kline Institute for Psychiatric Research
First posted: 2018-08-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in Aggression
timeFrame: Change from baseline in aggression measures up to the end of intervention at 4 months
Secondary outcomes:
measure: Change in cognitive outcomes
timeFrame: Change from baseline in cognition measures up to the end of intervention at 4 months
measure: Change in Emotionality
timeFrame: Change from baseline in emotionality measures up to the end of intervention at 4 months
measure: Change in Emotion Regulation Capacity
timeFrame: Change from baseline in measures up to the end of intervention at 4 months
measure: Change in Impulse Control
timeFrame: Change from baseline in impulse control measures up to the end of intervention at 4 months
Other outcomes:
measure: Change in psychotic symptoms
timeFrame: Change from baseline in psychotic symptom measure up to the end of intervention at 4 months
Locations:
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
city: White Plains
country: United States
facility: NewYork Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Anthony O Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manhattan Psychiatric Center
name: Jean-Pierre Lindenmayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nathan Kline Institute for Psychiatric Research
name: Matthew J Hoptman, PhD
role: PRINCIPAL_INVESTIGATOR
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