Mindfulness-based Psychotherapy for Drug-resistant Epilepsy

NCT ID: NCT02060422

Last Updated: 2014-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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Epilepsy Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Social support group

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.

Group Type PLACEBO_COMPARATOR

Social support group

Intervention Type BEHAVIORAL

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.

Mindfulness-based therapy

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.

Group Type EXPERIMENTAL

Mindfulness-based therapy

Intervention Type BEHAVIORAL

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.

Interventions

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Mindfulness-based therapy

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.

Intervention Type BEHAVIORAL

Social support group

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Venus Tang

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Venus Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Neurosurgery, Faculty of Medicine, CUHK

Locations

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CUHK Division of Neurosurgery, Faculty of Medicine

Hong Kong, Hong Kong, Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CRE-2011.167-T

Identifier Type: OTHER

Identifier Source: secondary_id

VP-2011

Identifier Type: -

Identifier Source: org_study_id

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