Mindfulness-based Intervention to Promote Psychological Wellbeing in People With Epilepsy

University of Malaya

Status: Completed

Conditions: Epilepsy; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases

Treatments: Behavioral: No-intervention; Behavioral: Mindfulness-based therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04313686

20175295282

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Mindfulness-based therapy

Experimental group

Description:

The mindfulness training program included mindfulness meditation practices, self-enquiries, mindful movement as well as understanding of stress physiology and cognitive awareness in the Breathworks/ Paradigm system of mindfulness-based approaches. Participants were enrolled in 5-10-person groups that met weekly for 2-3-hour long sessions for six weeks at the patient's usual follow-up clinic.

Treatment:

Behavioral: Mindfulness-based therapy

No-Intervention

Active Comparator group

Description:

The control group would attend their routine follow-up visits at the neurology outpatient clinic.

Treatment:

Behavioral: No-intervention