Mindfulness-based Psychotherapy for Drug-resistant Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060422
• Other study ID #: VP-2011
• Secondary ID: CRE-2011.167-T
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 10, 2014
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	CUHK Division of Neurosurgery, Faculty of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No