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

NCT ID: NCT01533649

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-09-30

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.

Detailed 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.

Conditions

Medically Intractable Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A/R intervention

The A/R intervention will accommodate 10 study subjects who will participate in an epilepsy-specific counseling intervention.

Group Type: EXPERIMENTAL

Andrews/Reiter approach to epilepsy

Intervention Type: BEHAVIORAL

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

The relaxation group will accommodate 10 study subjects who will participate in a condition unspecific supportive relaxation intervention.

Group Type: EXPERIMENTAL

Relaxation/Meditation

Intervention Type: BEHAVIORAL

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.

Usual care

10 Potential study subjects who are not interested in participating in either intervention will be asked to provide data as a usual care control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

A/R intervention

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taufik A Valiante, MD PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hospital; University Health Networks

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Taufik A Valiante, MD PhD FRCS

Role: CONTACT

taufik.valiante@uhn.ca

647-261 ext. 7823

Facility Contacts

Taufik A Valiante, MD PhD FRCS

Role: primary

taufik.valiante@uhn.ca

416-603 ext. 5460

References

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.

Reference Type: BACKGROUND

PMID: 10775516 (View on PubMed)

Related Links

http://www.andrewsreiter.com/

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

Other Identifiers

PHOENICS-01

Identifier Type: -

Identifier Source: org_study_id