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.
