Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04313686
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2020-03-16
Brief Title:
Mindfulness-based Intervention to Promote Psychological Wellbeing in People With Epilepsy
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
Mindfulness-based Intervention to Promote Psychological Wellbeing in People With Epilepsy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The efficacy of mindfulness-based intervention MBI for epilepsy has yet to be thoroughly investigated Hence the aim of the present study is to examine the effects of MBI on the psychological wellbeing of people with epilepsy PWE using a randomized trial design Key outcomes include depression anxiety and quality of life Our primary objective was to evaluate the effect of mindfulness-based therapy on anxiety depression epilepsy specific QOL and life satisfaction in PWE applying the concept of Reliable Change Index The secondary objective was to assess whether the results correlate with the level of mindfulness Study results may be used to decide whether it is worth offering mindfulness training for PWE as an alternative therapy to cope and improve seizure management
Detailed Description:
Epilepsy is a debilitating condition characterized by sudden recurrent episodes of epileptic seizures Psychiatric comorbidities are common in people with epilepsy PWE and the presence is associated with increased rates of suicide healthcare costs mortality and reduced quality of life Studies showed that poor health-related quality of life HRQOL has been linked to seizure frequency medication side effects psychological disturbances and psychosocial difficulties Medical therapies aside psychological interventions like mindfulness-based interventions MBIs were proven effective in improving psychological health as well as seizure control Recent review was conducted to determine the efficacy of MBIs for PWE Although promising results showed reduction in levels of psychological distress and improvement in quality of life the extracted findings were based on three articles which limit the applicability of the findings More research focusing on MBIs for PWE are required to make comparisons on its beneficial effects Hence this present study aimed to examine the effects of MBI on psychological wellbeing among PWE using a randomized controlled trial design
This study trial recruits 30 participants with epilepsy Participants are recruited from the neurology outpatient treatment clinic and those who consented are randomized into either the intervention active or no-intervention group All participants receive six weekly-sessions of mindfulness training that lasted for 25-hour Assessments are conducted at three time-points T0 before intervention T1 immediately after intervention and T2 at the 6-weeks followup The following outcome measures assessing depression BDI-II anxiety BAI quality of life QOLIE-31 mindfulness MAAS and satisfaction with life SWLS are collected at all three time-points
This study trial recruits 30 participants with epilepsy Participants are recruited from the neurology outpatient treatment clinic and those who consented are randomized into either the intervention active or no-intervention group All participants receive six weekly-sessions of mindfulness training that lasted for 25-hour Assessments are conducted at three time-points T0 before intervention T1 immediately after intervention and T2 at the 6-weeks followup The following outcome measures assessing depression BDI-II anxiety BAI quality of life QOLIE-31 mindfulness MAAS and satisfaction with life SWLS are collected at all three time-points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None