Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
The assumption of the unpredictability of seizures may have an enormous impact on the
 perception of self-efficacy and may contribute more to a patient's poor quality-of-life than
 the actual seizures. Patients with epilepsy are especially susceptible to the influence of
 the arbitrary nature of this condition on socialization,education,and the formation of
 self-identity. Consequentially, the psychosocial and psychological aftermath is likely to be
 observed even in individuals with well-controlled seizures. The relationship between seizure
 occurrence and the effects of having epileptic seizures on quality of life can be
 characterized as reciprocal; e.g. emotional stress is not only a result of having seizures;
 it is also the most frequently reported seizure precipitant. Whereas behavioral interventions
 have repeatedly been considered as the third pillar of the treatment of epilepsy, the main
 focus still remains on passive seizure control per pharmacological and surgical
 interventions, which may further aggravate victimization. Outcome after epilepsy surgery is
 closely correlated with pre-surgical characteristics. Consequentially, there is an upsurge of
 interest in the medical community for research on non-pharmacologic interventions to
 facilitate the transition from chronically sick to well with preventive therapeutic
 interventions in the context of habitual seizures. The Andrews/Reiter (AR) approach to
 epilepsy is a systematic counseling intervention that assists the individual to identify
 seizure warning signs,seizure precipitants and general life stressors in order to develop
 strategies of active seizure control and improve self-defined life quality. Literature review
 indicates that AR represents the most comprehensively developed psychological approach. The
 proposed trial will address the question if AR decreases seizure frequency and
 psychopathologic comorbidities and increases seizure self-efficacy and overall quality of
 life in patients with medically intractable epilepsy.
Potential subjects will be systematically approached during a 3 years enrollment period to
 recruit a consecutive sample of the patient population receiving care at a tertiary care
 epilepsy center (Toronto Western Hospital). After an 8 week period to establish baseline
 measurements the proposed trial will allocate study subjects to an A/R intervention group or
 a relaxation/meditation control group or a usual care control group (N1=N2=N3=10) per their
 preference due to the fact that internalization of the therapeutic principles is an active
 process that requires continuous motivation and compliance of the patient with the
 intervention. If a subject displays high intrinsic motivation to engage in self-care
 enhancing activities but does not indicate a preference, he or she will get randomized to
 either the A/R intervention or the relaxation protocol. This trial design allows for
 measuring effect sizes in regard the potential effect of choice, and also whether there is
 any interaction between preference and treatment.

 This trial will determine the following:

 I. The fraction of (a) seizure-free subjects and (b) subjects with clinically meaningful,
 i.e. ≥ 90% or ≥ 50 reduction of seizure frequency, II. Changes of the subjective perception
 of disability as indicated by Subjective Handicap of Epilepsy Scale (SHE), III. Changes of
 seizure self-efficacy as indicated by Multidimensional Health Locus of Control (M-HLOC), Form
 C and Epilepsy Self-Efficacy Scale (ESES), IV. Changes in common psychopathologic
 comorbidities and stress as indicated by (a) Neurological Disorders Depression Inventory in
 Epilepsy (NDDI-E), (b) State Trait Anxiety Inventory (STAI), (c) Profile of Mood States (POMS
 brief), and (d) Perceived Stress Scale (PSS), V. Changes in quality of life as indicated by
 (a) Quality of Life in Epilepsy (QOLIE-89), (b) individually identified descriptors of
 various domains of life and (c) individually identified epilepsy-related distresses.
 Continuous measures (aims I and III b) will be obtained during months 9 and 10 after initial
 subject enrollment. All other measures will be obtained at the end of month 10.

 Intervention Protocols: During months 3-5 the A/R intervention protocol devotes one
 face-to-face counseling session to each of the 11 chapters ("steps") of the workbook "Taking
 control of your epilepsy" which will be followed by weekly phone calls during months 6-8. A/R
 treatment plans include daily activities: Journaling (10 min), CD-guided relaxation (10-30
 min), Workbook (10 min) to promote functional analysis of seizure context and development of
 coping strategies. The trial will be used for knowledge-translation as trainees delivering
 the intervention will be supervised by Donna Andrews, PhD, co-developer of the AR
 intervention. The relaxation and meditation protocol will consist of weekly 30 min session
 during months 3-5 and bi-weekly 60 min sessions during months 6-8.

 All subjects are instructed to document seizure occurrences (number and type) and compliance
 with AEDs. They will continue to see their treating neurologist and adjustment of their
 antiepileptic medication will be made if necessary. Medication changes will be included in
 outcome analyses. Regular serum levels will be drawn to monitor drug compliance. Study
 subjects will be approached at 12, 24 and 36 months after the end of the pilot trial to
 obtain follow-up data. The sample size determination the investigators based on literature
 review, assuming the remission rate for the usual care group was 5% and 35% for the A/R
 intervention group and inflated by 30% to account for loss to non-compliance. Outcomes will
 be compared as found in groups as a whole.
Inclusion Criteria:

 -  Age 18-40 years old

 -  Fluency in English, including reading and writing

 -  Confirmed diagnosis of epilepsy as indicated by review of medical records (video-EEG,
 routine EEG and imaging)

 -  Drug-refractoriness as indicated by at least two failures to achieve seizure freedom
 per adequate drug trials in the patient's history

 -  Eligibility to be subjected to a surgical intervention aiming at seizure reduction

 -  A baseline seizure frequency of at least two complex partial seizures per month

 -  Willingness not to begin another non-pharmaceutical treatment while enrolled in the
 study

 -  Readiness to attempt not to change pharmaceutical treatment while enrolled in the
 study

 -  Motivation to comply with the intervention protocols

 Exclusion Criteria:

 -  A history of a relapsing remission course of epilepsy

 -  Presumed psychogenic events

 -  Scheduled or likely change of treatment within 8 months after enrollment in the trial

 -  Negative compliance history

 -  Noncompliance with baseline measurement

 -  A seizure frequency of less than two seizures per month during baseline measurement

 -  Serious other medical problems, such cancer, stroke, significant heart disease,
 psychiatric disorders

 -  Brain tumors, vascular malformations, progressive epilepsy syndromes,
 neurodegenerative disorders or significant developmental delay (IQ<80)