Can Cognitive Training Decrease Reactive Aggression?
Primary Purpose
Schizophrenia, Cognitive Deficits, Impulsive Aggression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation (CRT)
CRT+ Social Cognition Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Remediation, Social Cognition Training, Emotion Regulation, Urgency
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)
Sites / Locations
- Manhattan Psychiatric Center
- NewYork Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cognitive Remediation (CRT)
CRT+ Social Cognition Training
Arm Description
Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities.
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.
Outcomes
Primary Outcome Measures
Change in Aggression
Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).
Secondary Outcome Measures
Change in cognitive outcomes
MATRICS Consensus Cognitive Battery (MCCB); Emotion Recognition-40 (ER-40); Reading the Mind in the Eyes (Eyes Task)
Change in Emotionality
Positive and Negative Affect Scale (PANAS); Toronto Alexithymia Scale (TAS); Observer Alexithymia Scale (OAS)
Change in Emotion Regulation Capacity
Picture viewing task completed while peripheral psychophysiological response is obtained
Change in Impulse Control
Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task
Full Information
NCT ID
NCT03623477
First Posted
August 3, 2017
Last Updated
February 26, 2020
Sponsor
Weill Medical College of Cornell University
Collaborators
Brain & Behavior Research Foundation, National Center for Advancing Translational Sciences (NCATS), Nathan Kline Institute for Psychiatric Research
1. Study Identification
Unique Protocol Identification Number
NCT03623477
Brief Title
Can Cognitive Training Decrease Reactive Aggression?
Official Title
Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2016 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Brain & Behavior Research Foundation, National Center for Advancing Translational Sciences (NCATS), Nathan Kline Institute for Psychiatric Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognitive Deficits, Impulsive Aggression, Emotion, Impulsivity
Keywords
Cognitive Remediation, Social Cognition Training, Emotion Regulation, Urgency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation (CRT)
Arm Type
Active Comparator
Arm Description
Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities.
Arm Title
CRT+ Social Cognition Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation (CRT)
Intervention Description
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
Intervention Name(s)
CRT+ Social Cognition Training
Intervention Description
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 Outcome Measure Information:
Title
Change in Aggression
Description
Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).
Time Frame
Change from baseline in aggression measures up to the end of intervention at 4 months
Secondary Outcome Measure Information:
Title
Change in cognitive outcomes
Description
MATRICS Consensus Cognitive Battery (MCCB); Emotion Recognition-40 (ER-40); Reading the Mind in the Eyes (Eyes Task)
Time Frame
Change from baseline in cognition measures up to the end of intervention at 4 months
Title
Change in Emotionality
Description
Positive and Negative Affect Scale (PANAS); Toronto Alexithymia Scale (TAS); Observer Alexithymia Scale (OAS)
Time Frame
Change from baseline in emotionality measures up to the end of intervention at 4 months
Title
Change in Emotion Regulation Capacity
Description
Picture viewing task completed while peripheral psychophysiological response is obtained
Time Frame
Change from baseline in measures up to the end of intervention at 4 months
Title
Change in Impulse Control
Description
Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task
Time Frame
Change from baseline in impulse control measures up to the end of intervention at 4 months
Other Pre-specified Outcome Measures:
Title
Change in psychotic symptoms
Description
Positive and Negative Syndrome Scale (PANSS). Scale total scores range from 30 to 210 with higher scores indicating greater symptom severity
Time Frame
Change from baseline in psychotic symptom measure up to the end of intervention at 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony O Ahmed, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Lindenmayer, MD
Organizational Affiliation
Manhattan Psychiatric Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew J Hoptman, PhD
Organizational Affiliation
Nathan Kline Institute for Psychiatric Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
NewYork Presbyterian Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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