Cognitive Behavioral Therapy vs Yoga nidra in Psychogenic Non-epileptic seizures

Phase 2

Not yet recruiting

Conditions: Other dissociative and conversiondisorders,

Registration Number: CTRI/2021/04/032758

Lead Sponsor: NA

Brief Summary: **Brief methodology:**

**Study population**: Patients attending inpatient or outpatient services and wards of department of Neurology and Psychiatry, AIIMS, New Delhi diagnosed with PNES and fulfilling the inclusion criteria will be enrolled

**Sample Size**: Since it is a pilot study, we will employ a total of 50 patients who will be randomised into the two arms. After getting written informed consent by patient or caregiver, patient will be randomised to interventional arm A and B.

**Randomization**: This will be based on computer generated random sequence allocation

Arm A- CBT + Yoga Nidra

Arm B- CBT+ Sham yoga nidra

CBT will be provided to the patients via an online module which encompasses 12 sessions, weekly one session which lasts for almost an hour. Yoga nidra practice is taught using copyrighted audio CD from Bihar school of Yoga after prior permission. Sham Yoga nidra involves an exercise that mimics yoga nidra but patients are not given instructions on the corresponding breath modulation and synchronization, body awareness and focus.

The interventions in either arms will be provided for a period of 3 months and outcome is assessed at the end of 6 months.

**Primary outcome measure**: Reduction in monthly episode frequency, measured at baseline and the end of study- i.e. 6 months

**Secondary outcome measures:**

i)        Duration of freedom from episodes

ii)      Change in quality of life, measured by QOLIE-31

iii)    Reduction in use of anti-seizure drugs

iv)    Improvement in psychological comorbidities, measured by HAMA and HAMD scales at baseline and end of 6 months

v)      Cost difference between CBT and YN

Data will be analyzed by using statistical software SPSS version 16 (SPSS Inc., Illinois, Chicago) for statistical analysis. Descriptive statistics will be used to summarize the

baseline characteristics of the study population. Appropriate

statistical tests will be used to analyse the results.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

i)Persons aged 18-70 years ii) Clinical diagnosis of PNES confirmed by home video and a similar episode induced in video-EEG with no ictal correlates.

Exclusion Criteria

: i) A coexistent diagnosis of epilepsy (past/current) ii) Current drug/alcohol dependence iii) Patients with episode frequency < 6 months iv) Patients with coexisting non-neurologic comorbidities like chronic cardiac, renal and other systemic diseases v)Patients not giving consent vi) Patients with intellectual disability vii) Patients with acute psychosis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in monthly episode frequency, measured at baseline and the end of study- i.e. 6 months	0, 6 months

Secondary Outcome Measures

Name	Time	Method
i)Duration of freedom from episodes	ii)Change in quality of life, measured by QOLIE-31

Trial Locations

Locations (1): Neurology and Psychiatry OPD and wards
🇮🇳
Delhi, DELHI, India
Neurology and Psychiatry OPD and wards
🇮🇳Delhi, DELHI, India
Dr Saranya B Gomathy
Principal investigator
8129606651
gomathysubramoniam@gmail.com