CTRI/2017/04/008385.
| Study name | Interventions for stigma for persons with epilepsy in India |
| Methods |
Study design: RCT Country: India |
| Participants | Adult patients with epilepsy Inclusion criteria: a. consenting; b. persons diagnosed as having epilepsy [As per definition of ILAE, at least two or more unprovoked or reflex seizures > 24 h apart or one unprovoked or reflex seizure with a probability of recurrence of at least 60% or diagnosis of an epilepsy syndrome]; c. persons with epilepsy who screen positive on Kilifi Stigma Scale for epilepsy. Exclusion criteria: a. non‐consenting; b. persons with epilepsy having any other clinically significant confounding physical/cognitive disability or stigmatizing condition (as determined by the attending physician); c. practising mediation/yoga regularly or sporadically for a period of three months or more prior to the recruitment period. Stated purpose: to evaluate the efficacy of an integrated yoga module as an intervention for reducing epilepsy‐related stigma in persons with epilepsy in India |
| Interventions |
Intervention: Integrated Yoga Module for Persons with Epilepsy (IYMPE) In addition to usual medical care, patients will be administered an Integrated yoga module for persons with epilepsy consisting of loosening practices (5 minutes), breathing exercises (10 minutes) and meditation (15 minutes). The intervention consists of 7 supervised sessions covered over a duration of 12 weeks. These sessions will be conducted by a trained yoga instructor. This module shall be supplemented with a structured session of psychoeducation regarding epilepsy and its psychosocial aspects. Control: Active control: sham yoga module (in addition to treatment‐as‐usual and psychoeducation module, patients shall be administered a sham yoga module consisting of 7 sessions covered over a duration of 12 weeks by a trained instructor. This group would be given exercises that mimic the yoga practices, but they would be not be given instructions on the corresponding breath modulation and synchronization, body awareness and focus, and chanting techniques that are the key components of yoga) |
| Outcomes |
Participants' outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (3 months and 6 months follow‐up) |
| Starting date | 24 April 2017 (first enrolment) |
| Contact information | Manjari Tripathi, mtripathiaiims@gmail.com |
| Notes |
Source of funding: All India Institute of Medical Sciences, Ansari Nagar East, Gautam Nagar, New Delhi‐110029 Prospective trial registration number: CTRI/2017/04/008385 |