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

NCT02465047 | Completed DMC

• 1 other identifier: STH17299
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Dissociative Seizures

Outcome Measures

Primary Outcomes (1)

• Health-related Quality of Life

  2 months

Study Arms (2)

Self-help booklet

EXPERIMENTAL

The intervention consists of a brief A5 self-help stress management booklet with an audio Compact Disk.

Other: Self-help booklet

Delayed Intervention

NO INTERVENTION

Participants do not receive the intervention until one month after the initial assessment.

Interventions

Self-help booklet OTHER

See Arm/Group Description

Self-help booklet

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2 JF, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy; Psychogenic Nonepileptic Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Seizures; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Reuber, Professor

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: June 8, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

GB (1)