Clinical Trial: Stress and Seizures - Can a Brief Self-help Book Help?
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Stress and Seizures - Can a Brief Self-help Book Help?
Brief Summary:
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.
Detailed Summary:
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 baseli
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Current Primary Outcome: Health-related Quality of Life [ Time Frame: 2 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sheffield Teaching Hospitals NHS Foundation Trust
Dates:
Date Received: April 17, 2015
Date Started: November 2014
Date Completion:
Last Updated: May 13, 2016
Last Verified: May 2016
