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Completed

NCT Number: NCT03623477

Can Cognitive Training Decrease Reactive Aggression?

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manhattan Psychiatric Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Aggression

    Time frame: Change from baseline in aggression measures up to the end of intervention at 4 months

    Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).

Secondary outcomes

  1. Change in cognitive outcomes

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

    MATRICS Consensus Cognitive Battery (MCCB); Emotion Recognition-40 (ER-40); Reading the Mind in the Eyes (Eyes Task)

  2. Change in Emotionality

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

    Positive and Negative Affect Scale (PANAS); Toronto Alexithymia Scale (TAS); Observer Alexithymia Scale (OAS)

  3. Change in Emotion Regulation Capacity

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

    Picture viewing task completed while peripheral psychophysiological response is obtained

  4. Change in Impulse Control

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

    Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task

Other outcomes

  1. Change in psychotic symptoms

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

    Positive and Negative Syndrome Scale (PANSS). Scale total scores range from 30 to 210 with higher scores indicating greater symptom severity

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Brain & Behavior Research Foundation
  • Nathan Kline Institute for Psychiatric Research
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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