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CTRI Number  CTRI/2021/04/032758 [Registered on: 12/04/2021] Trial Registered Prospectively
Last Modified On: 12/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Cognitive Behavioral Therapy vs Yoga nidra in Psychogenic Non-epileptic seizures 
Scientific Title of Study   A Randomised Controlled Trial Comparing the Efficacy of Cognitive Behavioral Therapy vs Yoga Nodra in Persons with Psychogenic Non-epileptic Seizures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Manjari Tripathi 
Designation  Professor in Neurology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Professor, Department of Neurology, Room 705, Neurosciences Centre, AIIMS, Delhi

New Delhi
DELHI
110023
India 
Phone  01126594494  
Fax    
Email  mantriaiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjari Tripathi 
Designation  Professor in Neurology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Professor, Department of Neurology, Room 705, Neurosciences Centre, AIIMS, Delhi
-
New Delhi
DELHI
110023
India 
Phone  01126594494  
Fax    
Email  mantriaiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Manjari Tripathi 
Designation  Professor in Neurology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Professor, Department of Neurology, Room 705, Neurosciences Centre, AIIMS, Delhi

New Delhi
DELHI
110023
India 
Phone  01126594494  
Fax    
Email  mantriaiims@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saranya B Gomathy  Neurology and Psychiatry OPD and wards  NS4 and NS5 wards, Neurology OPDs (Room 1-8) in ground floor of CN Centre AIIMS
New Delhi
DELHI 
8129606651

gomathysubramoniam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F448||Other dissociative and conversiondisorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cognitive Behavioral therapy  Given to Arm A-weekly one session for 12 weeks 
Intervention  Cognitive Behavioral therapy and Yoga nidra  CBT-12 sessions over three months, weekly one session Yoga nidra-5 days in a week for three months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  : 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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in monthly episode frequency, measured at baseline and the end of study- i.e. 6 months
 
0, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
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
 
0,6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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