EpilepsyNCT02465047
Stress and Seizures - Can a Brief Self-help Book Help?
A study testing Self-help booklet in people with Epilepsy and Dissociative Seizures, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Dissociative Seizures
- What is being tested?
- Self-help booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
About this study
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.
Read the detailed description
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.
Both groups are then contacted again by letter (or telephone) for a final follow-up two months after the initial assessment. Participants are asked to complete the quality of life, stress, anxiety, depression, and seizure severity questionnaires, to submit their seizure diaries and to provide two final saliva samples, one in the morning and one in the evening.
- Conditions
- Epilepsy, Dissociative Seizures
- Being tested
- Self-help booklet
- Medical subject headings
- Epilepsy, Psychogenic Nonepileptic Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help bookletOther
See Arm/Group Description
| Study group | Role | What they receive |
|---|---|---|
| Self-help booklet | Experimental | The intervention consists of a brief A5 self-help stress management booklet with an audio Compact Disk. Receives: Other: Self-help booklet |
| Delayed Intervention | No intervention | Participants do not receive the intervention until one month after the initial assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Reuber, Professor, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465047
- Sponsor's protocol ID
- STH17299
- Status last verified
- May 2016
- First submitted
- 17 Apr 2015
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Seizures - Can a Brief Self-help Book Help?
- ClinicalTrials.gov ID
- NCT02465047
- Acronym / sponsor ID
- STH17299
- Conditions
- Epilepsy, Dissociative Seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Both groups are then contacted again by letter (or telephone) for a final follow-up two months after the initial assessment. Participants are asked to complete the quality of life, stress, anxiety, depression, and seizure severity questionnaires, to submit their seizure diaries and to provide two final saliva samples, one in the morning and one in the evening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help booklet | Experimental | Other: Self-help bookletThe intervention consists of a brief A5 self-help stress management booklet with an audio Compact Disk. |
| Delayed Intervention | No intervention | –Participants do not receive the intervention until one month after the initial assessment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help bookletSee Arm/Group Description | Other | Self-help booklet |
Primary outcome
Health-related Quality of Life
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Reuber, Professor principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help booklet in people with Epilepsy and Dissociative Seizures, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.