NCT02060422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

February 10, 2014

Last Update Submit

February 10, 2014

Conditions

EpilepsyStress

Keywords

EpilepsyDrug-resistant epilepsySeizureMindfulnessStressPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Social support group

PLACEBO COMPARATOR

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

Mindfulness-based therapy

EXPERIMENTAL

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

Interventions

Mindfulness-based therapyBEHAVIORAL

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.

Mindfulness-based therapy
Social support groupBEHAVIORAL

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.

Social support group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK Division of Neurosurgery, Faculty of Medicine

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

EpilepsyDrug Resistant EpilepsySeizures

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Venus Tang, PhD

    Division of Neurosurgery, Faculty of Medicine, CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 12, 2014

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

HK(1)