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

NCT04313686 | Completed

• 1 other identifier: 20175295282
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Keywords

Mindfulness; Epilepsy; Quality of life; Depression; Psychotherapy

Outcome Measures

Primary Outcomes (3)

• Beck Anxiety Inventory (BAI)

  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.

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

• Beck Depression Inventory (BDI-II)

  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.

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

• Quality of Life in Epilepsy Inventory (QOLIE-31)

  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.

  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 (2)

• Mindful Attention Awareness Scale (MAAS)

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

• Satisfaction with Life Scale (SWLS)

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

Study Arms (2)

Mindfulness-based therapy

EXPERIMENTAL

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.

Behavioral: Mindfulness-based therapy

No-Intervention

ACTIVE COMPARATOR

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

Behavioral: No-intervention

Interventions

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.

Mindfulness-based therapy

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.

No-Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Prof. Dr. Lim Kheng Seang, MBBS, PhD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: January 10, 2018
• Primary Completion: December 10, 2019
• Study Completion: March 31, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

MY (1)