Back to resultsMindfulness-based Psychotherapy for Drug-resistant Epilepsy
Primary Purpose
Epilepsy, Stress
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness-based therapy
Social support group
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Drug-resistant epilepsy, Seizure, Mindfulness, Stress, Psychotherapy
Eligibility 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
Sites / Locations
- CUHK Division of Neurosurgery, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Social support group
Mindfulness-based therapy
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT02060422
First Posted
February 10, 2014
Last Updated
February 10, 2014
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02060422
Brief Title
Mindfulness-based Psychotherapy for Drug-resistant Epilepsy
Official Title
Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Stress
Keywords
Epilepsy, Drug-resistant epilepsy, Seizure, Mindfulness, Stress, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social support group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Mindfulness-based therapy
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Mindfulness-based therapy
Intervention Description
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
Intervention Name(s)
Social support group
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venus Tang, PhD
Organizational Affiliation
Division of Neurosurgery, Faculty of Medicine, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
CUHK Division of Neurosurgery, Faculty of Medicine
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Mindfulness-based Psychotherapy for Drug-resistant Epilepsy
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