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CTRI Number  CTRI/2024/10/075669 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effectiveness of a new therapy for teenagers with movement problems that do not have a clear medical cause 
Scientific Title of Study   A Study of applicability of IPS clinical practice guidelines in adolescents with Functional neurological disorder 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandhya Verma 
Designation  Junior Resident 
Affiliation  Department of Psychiatry King George Medical University Lucknow UP,India 
Address  Department of Psychiatry King George Medical University Lucknow UP,India

Lucknow
UTTAR PRADESH
226003
India 
Phone  98076456358  
Fax    
Email  vsandhya101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vivek Agarwal 
Designation  Professor and Head of department of psychiatry 
Affiliation  King George Medical University 
Address  Head of Department Ground floor chamber
Department of Psychiatry King George Medical University Lucknow UP India
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839287480  
Fax    
Email  drvivekagarwal06@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandhya verma 
Designation  Junior resident 
Affiliation  Department of Psychiatry King George Medical University Lucknow UP,India 
Address  Department of Psychiatry King George Medical University Lucknow UP,India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9807645358  
Fax    
Email  vsandhya101@gmail.com  
 
Source of Monetary or Material Support  
King George Medical University Shah mina road Chowk Lucknow Uttar pradesh India 226003 
 
Primary Sponsor  
Name  Department of Psychiatry King George Medical University Lucknow UP,India 
Address  Department of Psychiatry King George Medical University Lucknow UP,India 
Type of Sponsor  Government medical college 
 
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 Sandhya verma  King george medical university  Child and adolescent psychiatry OPD Department of Psychiatry
Lucknow
UTTAR PRADESH 		 9807645358

vsandhya101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George Medical University Lucknow UP,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F445||Conversion disorder with seizuresor convulsions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief Psychological intervention module  Patients 10 to16 years attending child and adolescent OPD Department of Psychiatry KGMU fulfilling the diagnosis of Functional neurological Disorder as per DSM5 criteria from Lucknow or nearby places will be included in the study after applying selection criteria and cases shall be selected from those fulfilling the criteria A written informed consent will be taken from the parent guardian and assent of the patient shall also be taken Diagnosis of functional neurological shall be made as per DSM5 criteria after detailed General physical and neurological examination Information regarding clinical history and socio-demographic details will be collected on semi structured proforma MSE will be done on same day KSADS PL (2016) will be applied to rule out any other psychiatric co morbidities Severity of the symptoms will be assessed using Functional neurological symptoms disorder scale and Clinical global impression severity scale WH05 wellbeing index will be used to asses psychological wellbeing of patient Following the initial assessments and diagnosis participants will be given a Brief psychological intervention module consisting of 6 intervention sessions twice a week guided by Clinical Practice Guidelines CPG aimed at evaluating the practicality of these guidelines in managing Functional neurological disorder CPG has been manualized for the purpose of study in 6 sessions These sessions can be conducted online (video call) if patient is unable to attend Amitriptyline 10-20 MG can be given to alleviate anxiety and sleep disturbances Follow up will be done after 1 week of completion of therapy and then every 2 weeks for the following 4 weeks Severity of the symptoms will be assessed using Functional neurological symptoms disorder scale Clinical global impression severity scale and Improvement scale will be applied to asses severity and improvement WH05 well-being index will be used to asses psychological wellbeing of patient These assessments will be conducted at baseline then weekly during therapy and subsequently after a week and biweekly for the following month during follow-up  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Adolescents aged 10 to 16 years
Diagnosed with Functional neurological symptom disorder as per DSM 5 criteria
Informed consent of primary caregiver and assent of the patient to participate in the study 
 
ExclusionCriteria 
Details  Any other psychiatric or neurological comorbidity
IQ less than 70
Uncooperative patient
Any Psychological intervention done in last 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The application of the IPS Clinical practice guidelines in the management of functional neurological disorder significantly improves clinical outcomes in adolescents aged 10 to 16 years attending child and adolescent psychiatry outpatient departments OPD compared to standard care  Baseline
1 weeks
2 weeks
3 weeks
4 weeks
6 weeks
8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   N/A 
Date of First Enrollment (India)   04/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vsandhya101@gmail.com].

  6. For how long will this data be available start date provided 27-09-2027 and end date provided 27-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The aim of this study is to investigate applicability of IPS CPG for managing functional neurological disorder in Adolescents aged 10 to16 years and to study improvement in symptom frequency and symptom severity of FND following intervention among adolescent population 

To compare the socio demographic and illness related variables between responders and non responders to treatment 

To assess the association of improvement with type of psychosocial factors if any

The application of the IPS Clinical practice guidelines in the management of functional neurological disorder significantly improves clinical outcomes in adolescents aged 10 to16 years attending child and adolescent psychiatry outpatient departments OPD compared to standard care the structured approach provided by IPS CPG will lead better clinical outcomes for this patient population
 
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