To evaluate the efficacy of an integrated yoga module as an intervention for reducing epilepsy related stigma in persons with epilepsy in India
Phase 2
- Conditions
- Health Condition 1: null- EpilepsyHealth Condition 2: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2017/04/008385
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Consenting
2. Persons diagnosed as having epilepsy [As per
definition of ILAE, at least two or more unprovoked or reflex seizures > 24hr apart or one unprovoked or reflex seizure with a probability of recurrence of at least 60% or diagnosis of an epilepsy syndrome].
3. Persons with epilepsy who screen positive on Kilifi Stigma Scale for epilepsy.
Exclusion Criteria
1)Non-Consenting
2)Persons with epilepsy having any other clinically significant confounding physical/ cognitive disability or stigmatizing condition (as determined by the attending physician).
3)Practicing mediation/ yoga regularly or sporadically for a period of three months or more prior to the recruitment period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)To evaluate the efficacy of an Integrated Yoga Module for Persons as intervention to reduce the stigma in persons with epilepsy as measured by Kilifi Stigma Scale.Timepoint: Baseline, 3 months and follow-up at 6 months
- Secondary Outcome Measures
Name Time Method To assess the changes in behavior, cognition and quality of Life in intervention and comparative arm using the following measures: Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Assessment-7 (GAD-7), Mindful Attention Awareness Scale (MAAS), Brooding Subscale of Response Styles Questionnaire (RSQ), Emotion Regulation Questionnaire (ERQ),Montreal Cognitive Assessment (MoCA), and Quality of Life in Epilepsy-10 (QoLIE-10)Timepoint: Baseline, 3 months and 6 months follow-up;To assess the changes in seizure frequency (as compared to the comparator group) after the administration of intervention.Timepoint: Baseline, 3 months and 6 months follow-up;To study the shift in EEG power spectra using high density EEG post intervention (as compared to the comparator arm) and their correlation with change in stigma scores.Timepoint: Baseline, 3 months