跳至主要内容
临床试验/NCT03527550
NCT03527550终止不适用

A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
46
试验地点
2
主要终点
Average Score on Negative Urgency Scale at Discharge

研究概览

简要总结

This study is designed to test whether computer-based cognitive exercises are helpful for reducing a specific type of impulsivity. Also, the study is testing whether these are exercises are associated with specific changes in behavior and in the brain. Participants will be psychiatric patients enrolled in a partial hospitalization program. Half of these participants will receive usual treatment, and half will complete computer-based cognitive exercises in addition to usual treatment.

详细描述

Impulsivity has different components. One personality trait related to impulsivity, known as "urgency," is strongly related to many different mental health symptoms and risky behaviors. Urgency refers to impulsivity specifically in the context of strong emotions.

Research shows that higher levels of urgency are related to specific deficits in cognition. Problems with response inhibition--the ability to cancel or withhold a planned action--are associated with urgency. Also, research shows that difficulties in another aspect of cognition--working memory--may moderate the relationship between inhibition deficits and urgency. One previous study found that people who practiced computerized response inhibition and working memory tasks for two weeks reported significant decreases in urgency.

It is unknown if these computerized tasks would be helpful for reducing urgency in adults with psychiatric disorders. Furthermore, it is unknown if changes in urgency are related to changes in the brain mechanisms that help to support response inhibition. This study will collect data on brain activity while people are completing response inhibition tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Currently receiving treatment at the McLean Hospital Behavioral Health Partial Hospital Program (PHP)
  • Report an average score of 3.0 or greater on the Negative Urgency scale, the Positive Urgency scale, or 3.0 or greater on both scales, upon admission to the PHP
  • Right-handed (if enrolled in EEG arm)

排除标准

  • Currently undergoing electroconvulsive therapy (ECT)
  • Current symptoms of acute mania
  • Current symptoms of acute psychosis
  • History of traumatic brain injury

结局指标

主要结局

Average Score on Negative Urgency Scale at Discharge

时间窗: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.

This scale assesses tendencies towards impulsive action in response to negative emotion. The scale ranges from 1-4, with higher scores indicating more problems with this type of impulsivity.

Average Score on the Short Positive Urgency Scale at Discharge

时间窗: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.

This scale assesses tendencies towards impulsive action in response to positive emotion. The scale ranges from 1-4, with higher scores indicating more problems with this type of impulsivity.

次要结局

  • Completion Rates(At study completion, an average of two weeks.)
  • Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge(Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.)
  • Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population(Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.)
  • Average Perceived Helpfulness of Training(At study completion, an average of two weeks.)

研究者

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

Andrew D. Peckham

Research Fellow

Mclean Hospital

研究点 (2)

Loading locations...

相似试验