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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2016年8月16日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Schizophrenia
发起方
Weill Medical College of Cornell University
入组人数
90
试验地点
2
主要终点
Change in Aggression
状态
已完成
最后更新
6年前

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.

注册库
clinicaltrials.gov
开始日期
2016年8月16日
结束日期
2019年10月25日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

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)

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)

研究点 (2)

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