Mindfulness-based Psychotherapy for Drug-resistant Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Venus Tang, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02060422
First received: February 10, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Epilepsy
Stress
Behavioral: Mindfulness-based therapy
Behavioral: Social support group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
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.
Experimental: 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.
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02060422

Locations
Hong Kong
CUHK Division of Neurosurgery, Faculty of Medicine
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Venus Tang, PhD Division of Neurosurgery, Faculty of Medicine, CUHK
  More Information

No publications provided

Responsible Party: Venus Tang, Dr, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02060422     History of Changes
Other Study ID Numbers: VP-2011, CRE-2011.167-T
Study First Received: February 10, 2014
Last Updated: February 10, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Epilepsy
Drug-resistant epilepsy
Seizure
Mindfulness
Stress
Psychotherapy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014