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临床试验/NCT03623477
NCT03623477已完成不适用

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

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change in Aggression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Cognitive Remediation (CRT) (Behavioral)

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.

干预措施: CRT+ Social Cognition Training (Behavioral)

结局指标

主要结局

Change in Aggression

时间窗: 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).

次要结局

  • Change in Emotionality(Change from baseline in emotionality measures up to the end of intervention at 4 months)
  • Change in cognitive outcomes(Change from baseline in cognition 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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