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CTRI Number  CTRI/2024/06/068359 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Short-term, cognitive behavioural therapy for reduction of Dissociative Seizures- A Short-Term Treatment Study 
Scientific Title of Study   A study on resolution of symptoms of dissociative seizures treated with adjuvant short-term psycho-dynamically oriented cognitive behavioural therapy  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Partha Sarathi Biswa 
Designation  Professor and head of department  
Affiliation  GB Pant Institute of PG medical education and research 
Address  Room no 613 6th floor academic block GB Pant Institute of PG medical education and research Maulana Azad Medical College New Delhi Central DELHI 110002 India

Central
DELHI
110002
India 
Phone  9718599095  
Fax    
Email  psbiswasmamc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Partha Sarathi Biswa 
Designation  Professor and head of department  
Affiliation  GB Pant Institute of PG medical education and research 
Address  Room no 613 6th floor academic block GB Pant Institute of PG medical education and research Maulana Azad Medical College New Delhi Central DELHI 110002 India

Central
DELHI
110002
India 
Phone  9718599095  
Fax    
Email  psbiswasmamc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Partha Sarathi Biswa 
Designation  Professor and head of department  
Affiliation  GB Pant Institute of PG medical education and research 
Address  Room no 613 6th floor academic block GB Pant Institute of PG medical education and research Maulana Azad Medical College New Delhi Central DELHI 110002 India

Central
DELHI
110002
India 
Phone  9718599095  
Fax    
Email  psbiswasmamc@gmail.com  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  Institutional Ethical Commitee, Maulana Azad Medical College and Associated Hospital 
Address  Maulana Azad Medical College and Associated Hospital, New Delhi 110002 
Type of Sponsor  Research institution and hospital 
 
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 Anisha chauhan  GB Pant Hospital  Ward No. 2, Psychiatry ward, Ground Floor, A Block
Central
DELHI 		 9610518101

chauhan.anisha94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College and associated hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F44||Dissociative and conversion disorders, (2) ICD-10 Condition: F44||Dissociative and conversion disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA FOR INTERVENTION GROUP
1. Age should be between 18-60years at the time of first contact.
2. Consecutive OPD and admitted patients meeting the criteria from International Classification of Disease 10 (ICD-10) for the diagnosis of conversion disorder with seizures or convulsions (F44.5, dissociative seizure) with or without co morbid diagnosis of depression (F32), adjustment disorder (F43.2) and mixed anxiety and depressive disorder (F41.2).
3. Patients developed symptoms of dissociative seizure (F44.5) in past six months and are treatment naive since then.
4. Patients should be cooperative for the assessment, intervention and formally educated up to minimum Vth grade.
5. Patents should have psychological mindedness and willing to visit hospital weekly.
6. Patient should consent for study as well as adjuvant psychological intervention in addition to conventional pharmacological management.
.
INCLUSION CRITERIA FOR CONTROL GROUP
1. OPD and admitted patients meeting the criteria from International Classification of Disease 10 (ICD-10) for the diagnosis of conversion disorder with seizures or convulsions (F44.5, dissociative seizure) with or without co morbid diagnosis of

depression (F32), adjustment disorder (F43.2) and mixed anxiety and depressive disorder (F41.2).
2. Patients have developed symptoms of dissociative seizure (F44.5) in past six months and are treatment naive since then.
3. Age should be between 18-60years at the time of first contact and matched with intervention group.
4. Age, gender and education (years) should be matched with intervention group.
5. Patients should be cooperative for the assessment, intervention and formally educated up to minimum Vth grade.
6. Those who are not adequately psychological minded or it is not possible to visit hospital weekly (e.g. stays far off place).
7. Patient should consent for study as well as only conventional pharmacological management. 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA FOR BOTH INTERVENTION AND CONTROL GROUP
1) Past history of any type of dissociative or other psychiatric disorder.
2) Patients having any hearing or vision problems.
3) Head injury, epilepsy or any structural brain lesion or organic brain syndrome (based
on clinical examination and investigation reports), dementia any endocrinological illness or taking the treatment for the same.
4) Those patients failed to attend three consecutive sessions of psychological intervention or not following instructions (e.g. medication compliance can’t be assured either verbally or conformed by checking empty foils, or not doing homework for psychological intervention etc) 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) Parameters of dissociative seizure like seizure frequency, seizure duration, awareness of event and semiology of seizure before treatment, during treatment sessions and one month after last session.  therapeutic sessions (10 weekly sessions ± booster 2 session) and one month (± one week) after intervention is completed.
 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of co morbid diagnosis if any [depression (F 32) to be assessed clinically as well as by Hamilton Depression Rating Scale 17, Hamilton M 1960)], adjustment disorder (43.2) [to be assessed clinically as well as by the adjustment disorder-new model 20 (ADNM-20), by Einsle et, 2010], and anxiety [to be assessed clinically as well as by Hamilton Anxiety Rating Scale (HAM-A), Hamilton M, 1959] before treatment, during treatment sessions and one month after last session.
2) Level of recent stressor in their life at those treatment points (to be assessed by The adjustment disorder-new model 20) (Einsle et, 2010).
2) Level of functioning (as assessed by Global Assessment of Functioning Scale, American Psychiatric Association 2013) at those treatment points. 		 10 weeks 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   17/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Given that patients suffering from dissociative disorder (DS) are frequently excluded from treatment studies of related disorders like PTST, DD either explicitly or implicitly, there is a need for outcome research for this population. Moreover, there is paucity of systematic study comparing efficacy of short term dynamically oriented CBT in DS patients. Given the prevalence and health care cost associated with dissociative seizure disorder (van der Kolk, 2008) especially in India rigorous research is needed so that firm conclusion can be made about the effectiveness of dissociative disorder focused treatment. The present study is an attempt to fill this void by seeing the progression of symptoms and functional abilities in the follow up patients of DS who are treated with such a short term combination of psychotherapy and pharmacotherapy. 
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