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Completed

NCT Number: NCT02060422

Mindfulness-based Psychotherapy for Drug-resistant Epilepsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUHK Division of Neurosurgery, Faculty of Medicine

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Therapy

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.

Social Support Group

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.

Primary outcomes

  1. Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention

    Time frame: Baseline, 4-week post-intervention

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 12, 2014
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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