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临床试验/NCT04414215
NCT04414215招募中不适用

Cognitive Training for Emotion Regulation in Psychotic Disorders

University of Georgia2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Prefrontal blood oxygen level dependent activation in the prefrontal cortex

研究概览

简要总结

The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.

详细描述

Psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and present major challenges to our health care system. Difficulties with emotion regulation (i.e., the ability to control the emotion response using strategies) significantly predict the development and maintenance of psychotic symptoms and poor community-based functional outcomes. Recent neuroimaging research indicates that hypofrontality may underlie these deficits. Unfortunately, there is no accepted technique for remediating these emotion regulation abnormalities in psychotic disorders. Recent advances from the field of cognitive neuroscience provide hope for a resolution to this critical unmet need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive training interventions are capable of improving emotion regulation ability by targeting neural activation in the prefrontal cortex. The goal of the proposed project is to determine whether an emotional working memory cognitive training program is effective for remediating emotion regulation abnormalities and associated clinical outcomes in people with psychotic disorders. Outpatients with psychotic disorders will be randomly assigned to either an emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control intervention delivered via an app on a smart phone for 30 days. The primary aim is to determine whether the emotional working memory intervention successfully engages the target mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer task beyond a pre-specified effect size criterion. Results will also be used to determine the treatment duration (15 vs. 30 days) that most effectively and efficiently improves the target.

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 (Investigator)

入排标准

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

入选标准

  • diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder
  • 18-60 years old
  • speaks English
  • premorbid intelligence quotient > 70
  • clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.

排除标准

  • history of intellectual disability or neurological disorder
  • history of traumatic brain injury with loss of consciousness > 10 minutes or behavioral sequelae
  • substance use disorder within the last 6 months (other than nicotine)
  • endorsement of MRI exclusion factors

结局指标

主要结局

Prefrontal blood oxygen level dependent activation in the prefrontal cortex

时间窗: Change from baseline to 15 days or 30 days

blood oxygen level dependent change in the prefrontal cortex as measured using functional magnetic resonance imaging. This will be calculated as a change from baseline to follow-up on the contrast score (unpleasant passive viewing condition - reappraisal) on the emotion regulation reappraisal task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Paul Strauss

Associate Professor

University of Georgia

研究点 (2)

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