Can Cognitive Training Decrease Reactive Aggression?

NCT ID: NCT03623477

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-16
• Study Completion Date: 2019-10-25

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.

Conditions

Schizophrenia; Cognitive Deficits; Impulsive Aggression; Emotion; Impulsivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Remediation (CRT)

Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities.

Group Type: ACTIVE_COMPARATOR

Cognitive Remediation (CRT)

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

CRT+ Social Cognition Training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony O Ahmed, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Jean-Pierre Lindenmayer, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Psychiatric Center

Matthew J Hoptman, PhD

Role: PRINCIPAL_INVESTIGATOR

Nathan Kline Institute for Psychiatric Research

Locations

Manhattan Psychiatric Center

New York, New York, United States

NewYork Presbyterian Hospital

White Plains, New York, United States

Countries

United States

Other Identifiers

UL1TR000457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1505016194

Identifier Type: -

Identifier Source: org_study_id