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NCT Number: NCT04313686

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

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.

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Key information

Conditions

Epilepsy Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Therapy

Behavioral

Based on randomization, those who first receive the mindfulness training program are the intervention group. Participants would meet weekly for 2-3-hour long sessions for six weeks at the patient's usual follow-up clinic.

No-intervention

Behavioral

Participants who were randomized into this group would continue to receive their usual follow-up care at the usual neurology outpatient clinic.

Primary outcomes

  1. Beck Anxiety Inventory (BAI)

    Time frame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)

    Total 21 items measuring cognitive, somatic and affective symptoms of anxiety. Each item is rated on a 4-point Likert scale for symptom severity experienced, ranging from 0 (not at all) to 3 (severely). The scores ranged between 0 to 63, with higher numbers suggesting greater degrees of anxiety.

  2. Beck Depression Inventory (BDI-II)

    Time frame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)

    Total 21 items assessing the presence and severity of depressive symptoms. All descriptive items were scored on a 4-point Likert scale ranging from 0 to 3. Total scores ranged from 0 to 63, higher scores represent higher degrees of depressive symptoms.

  3. Quality of Life in Epilepsy Inventory (QOLIE-31)

    Time frame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)

    Total 31 items reflects the patient's subjective well-being toward his or her QOL in various aspects related to epilepsy, with higher scores indicating better well-being.

Secondary outcomes

  1. Mindful Attention Awareness Scale (MAAS)

    Time frame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)

    Total 15 items were each rated on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never) to measure the core characteristic of dispositional mindfulness.

  2. Satisfaction with Life Scale (SWLS)

    Time frame: Three time-points: T0: (prior to therapy), T1: (immediately after intervention), T2 (three-month after phase one after no-intervention wash-out period)

    Total 5 items were each rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree) to assess one's global cognitive judgements of individual's life satisfaction.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Mindfulness-based Intervention to Promote Psychological Wellbeing in People With Epilepsy: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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