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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014