Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services

Medically Intractable Epilepsy Clinical Trial

— PHOENICS  

Official title:

Pilot Trial: Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01533649
• Other study ID #: PHOENICS-01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2012
• Last updated: February 10, 2012
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2012
• Source: University Health Network, Toronto
• Contact: Taufik A Valiante, MD PhD FRCS
• Phone: 647-261
• Email: taufik.valiante[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Medically Intractable Epilepsy

Intervention

Behavioral:
• Andrews/Reiter approach to epilepsy
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.
• Relaxation/Meditation
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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Reiter JM, Andrews DJ. A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Seizure. 2000 Apr;9(3):198-203. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Fraction of subjects achieving a clinically meaningful reduction of seizure frequency	The fraction of subjects achieving a clinically meaningful reduction of seizure frequency will be determined. Reduction of seizure frequency will be categorized as = 90% reduction of seizures or = 50% reduction of seizures	Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.	No
Secondary	Subjective Handicap of Epilepsy	Changes as indicated by the completion of the subjective Handicap of Epilepsy 32-item (SHE) scale at baseline and at the end of month 10 after subject enrollment.	Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment	No
Secondary	Health-related self-efficacy	Changes as indicated by the completion of the 18-item Multidimensional Health Locus of Control (M-HLOC) Questionnaire.Different aspects of efficacy in the self-management of epilepsy will be measured using the 2000 version 33-item Epilepsy Self-Efficacy Scale (ESES). The fraction of days with reported medication side effects will be determined comparing documentations obtained during the initial 8 weeks of baseline measurement with adverse event documentation obtained during months 9 and 10 after initial subject enrollment.	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.	No
Secondary	Psychopathologic disorders and stress	Changes in the 6-item Neurological Disorders Depression Inventory in Epilepsy (NDDI-E), the State Trait Anxiety Inventory (STAI), the 30-item Profile of Mood States (POMS-Brief), and the 14-item Perceived Stress Scale (PSS)	Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment.	No
Secondary	Quality of life	Changes in regard to 89-item Quality of Life in Epilepsy (OLIE-89) questionnaire.	Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment	No

External Links

•   Link to Andrews/Reiter epilepsy research.inc who have been applying the studied intervention for more than 30yrs.