Mindfulness-based Psychotherapy for Drug-resistant Epilepsy

Not Applicable

Completed

• Conditions: Stress; Epilepsy
• Interventions: Behavioral: Social support group; Behavioral: Mindfulness-based therapy

• Registration Number: NCT02060422
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Status Verified: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Last Update Submitted: 2014-02-10
• Study First Posted: 2014-02-12
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social support group	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.
Mindfulness-based therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CUHK Division of Neurosurgery, Faculty of Medicine; 🇭🇰 Hong Kong, Hong Kong