Cognitive Deficits, Emotion, Impulsive Aggression, Impulsivity, Schizophrenia
Conditions
Keywords
Cognitive Remediation, Social Cognition Training, Emotion Regulation, Urgency
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALCRT+ 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.
Sponsors
Brain & Behavior Research Foundation
National Center for Advancing Translational Sciences (NCATS)
Nathan Kline Institute for Psychiatric Research
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aggression | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive outcomes | 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) |
| Change in Emotionality | 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) |
| Change in Emotion Regulation Capacity | Change from baseline in measures up to the end of intervention at 4 months | Picture viewing task completed while peripheral psychophysiological response is obtained |
| Change in Impulse Control | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in psychotic symptoms | 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 |
Countries
United States
Outcome results
None listed