Mindfulness-based Psychotherapy for Drug-resistant Epilepsy

Study Overview
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Brief Summary
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Psychological problems are prevalent among patients with drug-resistant epilepsy. The bi-directional interaction between psychological well-being and seizure have been recognized in recent years. Reduction of psychological stress has the potential to improve seizure manifestation. The present study uses an assessor-blinded prospective randomized controlled trial to evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social support on improving psychological well-being, seizure control and cognitive performance among adult patients with drug-resistant epilepsy.

Official Title
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Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy

Conditions
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Epilepsy, Stress

Intervention / Treatment
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* Behavioral: Mindfulness-based therapy
* Behavioral: Social support group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of epilepsy over 18 years of age resistant to pharmacological treatment according to the ILAE guideline no previous history of neurosurgery adequate level of reading and understanding ability to fill in questionnaires capable to communicate with the investigator with considerable expressive capacity patients who agree to cooperate with the study procedures required by the protocol patients who understand the nature of the study, agree to participate and sign the informed consent form Exclusion Criteria: with primary diagnosis of substance use disorder, mood disorder, bipolar affective disorder, psychosis, or organic mental disorder with diagnosis of learning disability or mental retardation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Social support group<br>Social support group is an attention-placebo with the same contact hours (four bi-weekly two-and-a-half-hour) as the experimental group, but without active treatment input. The aim of the social support group is to provide a supportive group atmosphere for patients with drug-resistant epilepsy. | Behavioral: Social support group<br>* Social support group is an attention-placebo with the same contact hours (four bi-weekly two-and-a-half-hour) as the experimental group, but without active treatment input. The aim of the social support group is to provide a supportive group atmosphere for patients with drug-resistant epilepsy.<br>|
| Experimental: Mindfulness-based therapy<br>Mindfulness-based therapy is a four biweekly two-and-a-half-hour psychotherapy tailored for patients with drug-resistant epilepsy. The aims of this therapy are to introduce and practice mindfulness-based stress reduction techniques in coping with drug-resistant epilepsy. | Behavioral: Mindfulness-based therapy<br>* Mindfulness-based therapy is a four biweekly two-and-a-half-hour psychotherapy tailored for patients with drug-resistant epilepsy. The aims of this therapy are to introduce and practice mindfulness-based stress reduction techniques in coping with drug-resistant epilepsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention |  | Baseline, 4-week post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Drug-resistant epilepsy, Seizure, Mindfulness, Stress, Psychotherapy