Can Cognitive Training Decrease Reactive Aggression?

NCT03623477 | Completed DMC

• 2 other identifiers: 1505016194UL1TR000457
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Cognitive Deficits; Impulsive Aggression; Emotion; Impulsivity

Keywords

Cognitive Remediation; Social Cognition Training; Emotion Regulation; Urgency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in cognitive outcomes

  Change from baseline in cognition measures up to the end of intervention at 4 months

• Change in Emotionality

  Change from baseline in emotionality measures up to the end of intervention at 4 months

• Change in Emotion Regulation Capacity

  Change from baseline in measures up to the end of intervention at 4 months

• Change in Impulse Control

  Change from baseline in impulse control measures up to the end of intervention at 4 months

Other Outcomes (1)

• Change in psychotic symptoms

  Change from baseline in psychotic symptom measure up to the end of intervention at 4 months

Study Arms (2)

Cognitive Remediation (CRT)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Remediation (CRT)

CRT+ Social Cognition Training

EXPERIMENTAL

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

Interventions

Cognitive Remediation (CRT) 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.

Cognitive Remediation (CRT)

CRT+ Social Cognition Training 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.

CRT+ Social Cognition Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Brain & Behavior Research Foundation: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Nathan Kline Institute for Psychiatric Research: collaborator

Study Sites (2)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

NewYork Presbyterian Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders; Impulsive Behavior; Emotional Regulation

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anthony O Ahmed, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Jean-Pierre Lindenmayer, MD

  Manhattan Psychiatric Center

  PRINCIPAL INVESTIGATOR

• Matthew J Hoptman, PhD

  Nathan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 9, 2018
• Study Start: August 16, 2016
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)