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临床试验/NCT03048695
NCT03048695已完成不适用

Cognitive Remediation of Executive Dysfunction - Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia

Sykehuset Innlandet HF2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2017年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
Conners Continuous Performance Test III

研究概览

简要总结

About 85% of patients with schizophrenia have cognitive impairments, executive functions being particularly affected. Executive dysfunction, and cognitive deficits in general, are important predictors of functional outcomes, including social problem solving, activities of daily living, life satisfaction, and the ability to return to work or school.The main objective of the current study is to examine the efficacy of group-based Goal Management Training (GMT) for patients with broad schizophrenia spectrum disorders or high risk individuals with executive deficits. The short term goals are to investigate whether GMT can improve participants' ability to organize and achieve goals in everyday life in addition to improving aspects of emotional health. A long-term goal would be to establish an evidence base for nonpharmacological interventions for patients with broad schizophrenia spectrum disorders or high risk for schizophrenia. Main research questions: (1) Does a RCT with GMT delivered to patients with broad schizophrenia spectrum disorders or high risk for schizophrenia result in improved executive functioning, measured by self-reported and/or objective measures of executive functions? (2) Does GMT result in improved goal attainment in everyday life, social- and real world functioning? (3) Does GMT have a positive impact on the patients' emotional health? (4) Are there specific characteristics in patients with broad schizophrenia spectrum disorders or high risk for schizophrenia that are associated with better treatment benefit from GMT?

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
16 Years 至 67 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being consecutively referred to treatment for a DSM-IV diagnosis of broad schizophrenia spectrum psychosis (schizophrenia, schizophreniform disorder and schizoaffective disorder) or high risk for psychosis or being treated for psychotic disorder for less than 5 years.
  • Reporting executive problems through (a) structured interview, or (b) self-report, i.e. BRIEF scale T-score < 55.

排除标准

  • Reported ongoing alcohol or substance abuse.
  • Premorbid neurological disease or insult and/or comorbid neurological disease. ° Severe cognitive problems interfering with the capacity to participate.
  • IQ below 70.

结局指标

主要结局

Conners Continuous Performance Test III

时间窗: Baseline, immediately post-intervention and 6 months follow-up

Assessing change

Behavior Rating Inventory for Executive Functions

时间窗: Baseline, immediately post-intervention and 6 months follow-up

Assessing change

Positive and Negative Syndrome Scale

时间窗: Baseline, immediately post-intervention and 6 months follow-up

Assessing change

次要结局

  • Global Assessment of Functioning-Split Version(Baseline, immediately post-intervention and 6 months follow-up)
  • The Hotel Task(Baseline, immediately post-intervention and 6 months follow-up)
  • Delis Kaplan Executive Function System (D-KEFS) subtests(Baseline, immediately post-intervention and 6 months follow-up)
  • Digit span and Letter-number sequencing(Baseline, immediately post-intervention and 6 months follow-up)
  • Iowa Gambling Task(Baseline, immediately post-intervention and 6 months follow-up)
  • The Perceived Quality of Life Scale(Baseline, immediately post-intervention and 6 months follow-up)
  • Rosenberg self-esteem scale(Baseline, immediately post-intervention and 6 months follow-up)
  • Dysexecutive Questionnaire (self-and informant)(Baseline, immediately post-intervention and 6 months follow-up)
  • Goal Attainment Scaling(Baseline, immediately post-intervention and 6 months follow-up)
  • Everyday Functioning from NORMENT Long time follow up questionnaires(Baseline, immediately post-intervention and 6 months follow-up)
  • General Perceived Self-Efficacy Scale(Baseline, immediately post-intervention and 6 months follow-up)
  • Cognitive Failures Questionnaire(Baseline, immediately post-intervention and 6 months follow-up)
  • Social Functioning Scale(Baseline, immediately post-intervention and 6 months follow-up)
  • Hopkins Symptom Checklist 10(Baseline, immediately post-intervention and 6 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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