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临床试验/NCT05282186
NCT05282186已完成不适用

What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2022年9月2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
134
试验地点
1
主要终点
Change in Social Skills Performance Assessment rating scale

研究概览

简要总结

This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age 18 to 65;
  • •DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder

排除标准

  • •the presence of a current organic brain syndrome;
  • •a current and severe substance use disorder (DSM-5);
  • •intellectual disability (DSM-5)

研究组 & 干预措施

Cognitive Enhancement Therapy

Experimental

CET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition.

干预措施: Cognitive Enhancement Therapy (Behavioral)

Social Skills Training

Active Comparator

The HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health.

干预措施: Social Skills Training (Behavioral)

结局指标

主要结局

Change in Social Skills Performance Assessment rating scale

时间窗: Measurement at 0, 6, 12 months

Social skills measure using role plays

Change in Social Adjustment Scale II

时间窗: Measurement at 0, 6, 12 months

Measure of ability to engage socially in community settings

Change in Heinrich Quality of Life Scale

时间窗: Measurement at 0, 6, 12 months

Measure of quality of life

次要结局

  • Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)(Measurement at 0, 6, 12 months)
  • Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)(Measurement at 0, 6, 12 months)

研究者

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

Raquelle Mesholam-Gately

Assistant Professor of Psychology

Beth Israel Deaconess Medical Center

研究点 (1)

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