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临床试验/NCT03857347
NCT03857347Unknown不适用

A Feasibility Study for a Psycho-education Intervention for People With a Functional Neurological Disorder.

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
The Medical Outcome Study 36-item Short Form Health Survey (SF-36)

研究概览

简要总结

This study aims to assess the feasibility of running a brief psychoeducation group intervention in an outpatient setting to assess the practicalities and benefits of offering this type of intervention for both clinicians and patients

详细描述

A Functional Neurological Disorder (FND) is when the brain has difficulties sending and receiving signals . As a result people can experience problems in how their body and senses work, but there is no physical problem to treat.

Currently there is little treatment to offer after diagnosis, this study will investigate the feasibility and potential benefit to offering a group intervention to people with FND. This group intervention will offer chance to access information and the opportunity to meet others with the similar difficulties. Eligible participants will be those currently attending neurology clinics within NHS Grampian. Participants will complete prior to, during and at 3 months after the group is completed. These measures include health care use of participants, reported physical symptoms, subjective quality of ife and mood we will also take a brief measure of attention and concentration. Reported physical symptoms, subjective quality of life and mood will also be collected before the first group and at the last group.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals aged between 18-64 years with a diagnosis of FND

排除标准

  • Anyone the clinical neuropsychologist/neurologist feels, as a result of their clinical judgement, lacks capacity to consent.
  • People who are unable to understand the information sheet due to English not being their first language.
  • Severe sensory impairment.
  • Anyone experiencing active severe psychiatric symptoms
  • A dependency on alcohol or recreational drugs
  • Learning disability as classified by ICD
  • Those unable to travel independently to attend group sessions due to the severity of their symptoms

研究组 & 干预措施

Brief Psychoeducation Intervention

Experimental

2 group session psychoeducation intervention feasibility study

干预措施: Psychoeducation Group for FND (Other)

结局指标

主要结局

The Medical Outcome Study 36-item Short Form Health Survey (SF-36)

时间窗: Baseline, Change from Baseline at Time 1 (2 weeks prior to group), Change from Baseline at Time 2 (4 weeks after Time 1), Time 3 change from baseline 3 months from Time 2

This outcome will measure potential change in self-reported health related quality of life using eight subscales

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Psychoeducation Group Intervention for FND | 临床试验