MedTrace Logo

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

NCT04313686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mindfulness-based therapy

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.

BEHAVIORAL

No-intervention

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

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Prof. Dr. Lim Kheng Seang, MBBS, PhD · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2019-12-10
Completion
2021-03-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04313686 on ClinicalTrials.gov