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临床试验/NCT02465047
NCT02465047已完成不适用

Stress and Seizures - Can a Brief Self-help Book Help?

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Health-related Quality of Life

研究概览

简要总结

Background: Epilepsy and nonepileptic attack disorder (NEAD) are chronic conditions that cause many patients to experience a great degree of stress in their everyday lives. Patients have also reported stress as the commonest trigger of their seizures, and animal studies suggest that stress can make seizures worse. A self-help intervention that would help people manage the stress they experience could therefore improve their quality of life and have positive effects on the frequency of their seizures.

Research Question: The study evaluates whether a self-help intervention in the form of a brief booklet can improve the quality of life and reduce the levels of stress of people who experience seizures. In addition, the study will explore the associations between seizure severity and frequency, physiological and self-reported stress, and anxiety and depression.

Design: The researchers are recruiting patients attending the Outpatient Neurology Clinic at the Royal Hallamshire Hospital and measure their quality of life and stress levels before, one month and two months after they have been given the self-help stress reduction booklet. The researchers will measure the changes in quality of life and stress levels using questionnaires and saliva samples.

详细描述

The study is a prospective randomised controlled trial. Patients are randomised to two groups, (1) an immediate intervention group that receives the self-help intervention immediately after recruitment, and (2) a delayed intervention group which receives the intervention at one-month follow-up. Patients are assessed at baseline, at one-month and at two-month follow-up.

Patients attending the neurology outpatient clinic with a confirmed diagnosis of either epilepsy or NEAD are invited to take part in the study. The diagnosis is based on a clinical judgement of a consultant neurologist. Information concerning the purposes and procedures of the study is sent to patients at least 48 hours in advance of their appointment in the neurology outpatient clinic.

Potential participants are screened for their suitability to take part in the study when they come to the neurology clinic. This is based on the exclusion/inclusion criteria and the patients' motivation to participate, which is assessed by five questions asking about the relevance of stress to their lives and to their seizure experiences as well as their interest in participating. Suitable participants have an opportunity to discuss any questions which have arisen from reading the patients information sheet with a member of the research team. Patients willing to take part in the project sign a consent form and complete a set of baseline questionnaires at the time of their hospital appointment with the neurologist, assessing their demographic characteristics, quality of life, stress levels, anxiety, depression, seizure frequency and severity, and their tendency to self-affirm spontaneously. As part of the baseline assessment, patients are also asked to provide two salivary samples the following day (one at 9am in the morning, one at 10pm in the evening) for a measure of baseline levels of salivary cortisol as a marker of physiological stress. Patients complete a seizure diary for the duration of the study.

Patients receive treatment according to the random allocation to the immediate or delayed intervention groups. Patients in the immediate intervention group are provided with a booklet containing the self-help materials as soon as they have provided baseline data and before they leave the hospital on the day of recruitment. They are encouraged to read and work through the booklet over the following week and the researcher contacts them by telephone one week after the baseline assessment, in order to check their progress and to obtain feedback on the booklet, provided they had previously consented to being contacted by telephone.

The first follow-up is arranged for both groups at one month after the initial assessment. Subjects are contacted by post. The follow-up assessment involves completing the quality of life, stress, anxiety, depression, and seizure severity questionnaires, submitting the seizure diary for the past month and providing two saliva samples, one in the morning and one in the evening. Patients in the delayed intervention group also receive the self-help intervention booklet as part of the first follow-up assessment and are encouraged to use the booklet in an accompanying letter. Patients in the delayed intervention group are further contacted by telephone one week after receiving the booklet and asked to provide feedback on their progress and on the booklet itself.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically firm diagnosis of epilepsy (and no additional NEAD) or NEAD (and no additional epilepsy)
  • Over the age of 16 years
  • Able to complete the self-report questionnaires and diary measure without help
  • Able to give informed consent

排除标准

  • Patients likely to have mixed seizure disorders (epilepsy and NEAD)
  • People who are unable to give informed consent
  • People who are unable to complete the self-report questionnaires and diary measure unaided
  • People who have not experienced a seizure within the last 12 months
  • People whose diagnosis remains uncertain

结局指标

主要结局

Health-related Quality of Life

时间窗: 2 months

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 (2)

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