Clinical trial NCT04313686: Mindfulness-based Intervention to Promote Psychological Wellbeing in People With Epilepsy
Official title: Mindfulness-based Intervention to Promote Psychological Wellbeing in People With Epilepsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Keywords: Mindfulness
Epilepsy
Quality of life
Depression
Psychotherapy
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 2.5-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.

Eligibility criteria: Inclusion Criteria:

* All patients (16 years or older) with a diagnosis of epilepsy by a neurologist and who were able to read and write English.

Exclusion Criteria:

* a diagnosis of severe learning disability or cognitive impairment that affects individuals who are unable to comply with study procedure, substance dependence, suicidality, and limited language proficiency.

Primary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)
measure: Beck Depression Inventory (BDI-II)
timeFrame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)
measure: Quality of Life in Epilepsy Inventory (QOLIE-31)
timeFrame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)
Secondary outcomes:
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
affiliation: University of Malaya
name: Prof. Dr. Lim Kheng Seang, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: