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临床试验/NCT04681807
NCT04681807已完成不适用

Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

The Royal Ottawa Mental Health Centre2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
2
主要终点
Change in emotion recognition performance from baseline - PENN Emotion Recognition Test

研究概览

简要总结

Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.

详细描述

All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or a control training program on iPad that includes commercial games and control emotional attention bias 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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Due to the nature of the intervention, treatment administrators will not be able to remain blind to group assignment; however, assessment staff, investigators, and participants will be blind to group assignment. Assessment staff and investigators will never be involved in the randomization or treatment procedures.

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between (or equal to) 15-35 years of age
  • Ability to read/speak fluent English
  • Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).

排除标准

  • No diagnosis of psychosis related disorder
  • Significant neurological or medical disorders that may produce cognitive impairment
  • Current epilepsy or previous history of seizures
  • Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
  • Recent history of substance abuse or dependence (within past 3 months)
  • MRI contraindication (e.g. metallic head implant, history of seizure, pacemaker, pregnancy, etc.)
  • Current IQ < 70 as measured by the Wechsler Abbreviated Scale of Intelligence Scale (WASI)

结局指标

主要结局

Change in emotion recognition performance from baseline - PENN Emotion Recognition Test

时间窗: baseline and post treatment (1 month)

Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions

Change in brain activity during emotion recognition tasks from baseline

时间窗: baseline and post treatment (1 month)

Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).

次要结局

未报告次要终点

研究者

发起方
The Royal Ottawa Mental Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Synthia Guimond

Principal Investigator

The Royal Ottawa Mental Health Centre

研究点 (2)

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