Can Cognitive Training Decrease Reactive Aggression?

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623477
• Other study ID #: 1505016194
• Secondary ID: UL1TR000457
• Status: Completed
• Phase: N/A
• Start date: August 16, 2016
• Est. completion date: October 25, 2019

Study information

• Verified date: February 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aggression
• Cognition Disorders
• Cognitive Deficits
• Cognitive Dysfunction
• Emotion
• Impulsive Aggression
• Impulsive Behavior
• Impulsivity
• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	New York	New York
United States	NewYork Presbyterian Hospital	White Plains	New York

Sponsors (4)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Brain & Behavior Research Foundation, Nathan Kline Institute for Psychiatric Research, National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in psychotic symptoms	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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