EpilepsyNCT02060422
Mindfulness-based Psychotherapy for Drug-resistant Epilepsy
A study testing Mindfulness-based therapy and Social support group in people with Epilepsy and Stress, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mindfulness-based therapy and Social support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
CUHK Division of Neurosurgery, Faculty of Medicine
Hong Kong, Hong Kong
About this study
Official title: Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy
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.
- Being tested
- Mindfulness-based therapy, Social support group
- Keywords
- Epilepsy, Drug-resistant epilepsy, Seizure, Mindfulness, Stress, Psychotherapy
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based therapyBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention
Measured: Baseline, 4-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Venus Tang, Chinese University of Hong Kong
- Investigators
- Venus Tang, PhD, Principal investigator, Division of Neurosurgery, Faculty of Medicine, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060422
- Sponsor's protocol ID
- VP-2011
- Other IDs
- CRE-2011.167-T
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT02060422
- Acronym / sponsor ID
- VP-2011
- Keywords
- Epilepsy, Drug-resistant epilepsy, Seizure, Mindfulness, Stress, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social support group | Placebo comparator | Behavioral: Social support groupSocial 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 | Experimental | Behavioral: Mindfulness-based therapyMindfulness-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based therapyMindfulness-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. | Behavioural | Mindfulness-based therapy |
| Social support groupSocial 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. | Behavioural | Social support group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venus Tang, PhD principal investigator
Division of Neurosurgery, Faculty of Medicine, CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based therapy and Social support group in people with Epilepsy and Stress, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.