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临床试验/NCT02505022
NCT02505022终止不适用

Role Functioning Changes in New Onset Symptoms

Northwestern University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
1
主要终点
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition

研究概览

简要总结

During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. This will happen in the context of providing treatment-as-usual to individuals who arrive seeking help with the early phases of mental illness.

详细描述

The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan.

While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 26 years
  • Individuals seeking treatment for psychiatric symptoms in a clinical care setting
  • Able to provide informed consent (age 18-26)
  • Subjects must consent to a review of the medical records in order to track changes in clinical symptoms
  • Fluent in English

排除标准

  • Adults unable to consent
  • Individuals who have not reached the age of 18
  • Pregnant women

研究组 & 干预措施

Treatment seeking patients

Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning.

干预措施: Pharmacotherapy (Drug)

Treatment seeking patients

Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning.

干预措施: Behavioral treatment (Behavioral)

结局指标

主要结局

Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition

时间窗: 1 year

次要结局

  • TASIT(1 year)
  • PONS(1 year)
  • BLERT(1 year)
  • SFS(1 year)
  • RFS(1 year)
  • ERS(1 year)
  • ASSIST(1 year)
  • UPSA(1 year)
  • EPT(1 year)
  • FAP(1 year)
  • Informant SLOF(1 year)
  • SLOF(1 year)

研究者

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

Will Cronenwett

MD

Northwestern University

研究点 (1)

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