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
|
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [NA] |
|
Details of Secondary Sponsor
|
|
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
|
|
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. |