Can Cognitive Training Decrease Reactive Aggression?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control

Conditions
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Schizophrenia, Cognitive Deficits, Impulsive Aggression, Emotion, Impulsivity

Intervention / Treatment
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* Behavioral: Cognitive Remediation (CRT)
* Behavioral: CRT+ Social Cognition Training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Remediation (CRT)<br>Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities. | Behavioral: Cognitive Remediation (CRT)<br>* 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.<br>|
| Experimental: CRT+ Social Cognition Training<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aggression | 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 | MATRICS Consensus Cognitive Battery (MCCB); Emotion Recognition-40 (ER-40); Reading the Mind in the Eyes (Eyes Task) | Change from baseline in cognition measures up to the end of intervention at 4 months | 
| Change in Emotionality | 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 | Picture viewing task completed while peripheral psychophysiological response is obtained | Change from baseline in measures up to the end of intervention at 4 months | 
| Change in Impulse Control | Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task | Change from baseline in impulse control measures up to the end of intervention at 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Remediation, Social Cognition Training, Emotion Regulation, Urgency