Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
PHOENICS
Pilot Trial: Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFebruary 15, 2012
February 1, 2012
1.4 years
February 6, 2012
February 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fraction of seizure free study subjects
The determination of the fraction of seizure-free study subjects will be the primary outcome measure of this pilot trial. Seizure freedom will be defined as absence of seizures (not auras) during months 9 and 10 after initial subject enrollment.
Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Secondary Outcomes (5)
Fraction of subjects achieving a clinically meaningful reduction of seizure frequency
Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Subjective Handicap of Epilepsy
Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment
Health-related self-efficacy
Change from baseline questionnaire scores and fraction of days with reported side effects obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Psychopathologic disorders and stress
Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment.
Quality of life
Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment
Study Arms (3)
A/R intervention
EXPERIMENTALThe A/R intervention will accommodate 10 study subjects who will participate in an epilepsy-specific counseling intervention.
Relaxation
EXPERIMENTALThe relaxation group will accommodate 10 study subjects who will participate in a condition unspecific supportive relaxation intervention.
Usual care
NO INTERVENTION10 Potential study subjects who are not interested in participating in either intervention will be asked to provide data as a usual care control group.
Interventions
The Andrews/Reiter approach to epilepsy is a systematic semi-directive, multi-modal counseling intervention that integrates conventional therapies, educational modules, psychological interventions and relaxation techniques in order to assist the individual in improving self-defined life quality. Face-to-face counseling sessions and supervision with telephone calls are based on a standardized workbook ("Taking Control of Your Epilepsy") as an on-going step-by-step guideline.
Subjects who participate in the relaxation control group will attend weekly relaxation sessions that will employ the following relaxation techniques: meditation, progressive muscle relaxation, autogenic training.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
Reiter JM, Andrews DJ. A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Seizure. 2000 Apr;9(3):198-203. doi: 10.1053/seiz.1999.0374.
PMID: 10775516BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taufik A Valiante, MD PhD FRCS
Toronto Western Hospital; University Health Networks
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 15, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
February 15, 2012
Record last verified: 2012-02