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A/R intervention for Epilepsy (PHOENICS Trial)

N/A
Waitlist Available
Led By Taufik A Valiante, MD PhD FRCS
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fraction of seizure free study subjects
Secondary study objectives
Fraction of subjects achieving a clinically meaningful reduction of seizure frequency
Health-related self-efficacy
Psychopathologic disorders and stress
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: RelaxationExperimental Treatment1 Intervention
The relaxation group will accommodate 10 study subjects who will participate in a condition unspecific supportive relaxation intervention.
Group II: A/R interventionExperimental Treatment1 Intervention
The A/R intervention will accommodate 10 study subjects who will participate in an epilepsy-specific counseling intervention.
Group III: Usual careActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,214 Total Patients Enrolled
13 Trials studying Epilepsy
1,484 Patients Enrolled for Epilepsy
Taufik A Valiante, MD PhD FRCSPrincipal InvestigatorToronto Western Hospital; University Health Networks
~2 spots leftby Nov 2025