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CTRI Number  CTRI/2024/06/069048 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 16/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   How well does online video therapy work compared to face-to-face therapy for treating obsessive-compulsive disorder: A study with randomly assigned participants. 
Scientific Title of Study   Efficacy of video-conference based cognitive behavioural therapy (v-CBT) in comparison with in-person cognitive behaviour therapy (IP-CBT) for obsessive-compulsive disorder: A Randomised Controlled Trial 
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 Ajay Kumar 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Room number 322 Department of Clinical psychology 3rd floor Dr MVG center National Institute of Mental Health and Neurosciences Hosur Road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9886426548  
Fax    
Email  ajaycog2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Kumar 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Room number 322 Department of Clinical psychology 3rd floor Dr MVG center National Institute of Mental Health and Neurosciences Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9886426548  
Fax    
Email  ajaycog2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Kumar 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Room number 322 Department of Clinical psychology 3rd floor Dr MVG center National Institute of Mental Health and Neurosciences Hosur road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9886426548  
Fax    
Email  ajaycog2010@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences 
Address  National Institute of Mental Health and Neurosciences Hosur Road Bengaluru Karnataka India 560029 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S K Deuri  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam   Dr. Priyadarshee Abhishek Department of Clinical Psychology, Academic Building, Fifth Floor, Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, District Sonitpur (Assam)PIN 784001, Post Box No: 15
Sonitpur
ASSAM 		 03712232652

lgbrimh-asm@nic.in 
Dr Ajay kumar  NIMHANS, Bengaluru  Room no 322, Department of Clinical Psychology, Dr. MVG Center, National Institute of Mental Health and Neuro Sciences, Hosur Road, Bengaluru, Karnatak, India pin code 560029
Bangalore
KARNATAKA 		 08026995942

ajaycog2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC National Institute of Mental Health and Neuro Sciences  Approved 
IEC, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, (2) ICD-10 Condition: F429||Obsessive-compulsive disorder, unspecified, (3) ICD-10 Condition: F428||Other obsessive-compulsive disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  In-person cognitive behaviour therapy (IP-CBT)   The key component of this treatment would be in-vivo (or imaginal) therapist-assisted ERP sessions, which is the gold standard practice in CBT for OCD. Cognitive Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD) is a structured, time-limited therapy that focuses on changing the thought patterns and behaviors associated with OCD. It often involves Exposure and Response Prevention (ERP), where patients are gradually exposed to feared objects or thoughts without engaging in compulsive behaviors, helping them to build tolerance and reduce anxiety over time. The goal is to break the cycle of obsessions and compulsions by altering dysfunctional beliefs and developing healthier coping mechanisms. In this arm, CBT will be delivered in person. There would be 17 to 20 sessions of 60 minutes to 90 minutes each. The total duration of the intervention will be three months.  
Intervention  video-conference based cognitive behavioural therapy (v-CBT)  Video-conference-based cognitive behavioral therapy (v-CBT) is a form of CBT delivered remotely through video calls. It offers the same structured, evidence-based approach as traditional in-person CBT, focusing on modifying dysfunctional thoughts and behaviors. V-CBT provides flexibility and accessibility, allowing patients to receive therapy from their homes while maintaining real-time interaction with a therapist. CBT will be delivered for patients with OCD through Zoom video calls. There would be 17 to 20 sessions of 60 minutes to 90 minutes each for a total duration of three months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adults over age 18 years;
2. Primary diagnosis of DSM-5 OCD;
3. Y-BOCS total severity score between 14 - 30;
4. On stable medications for at least 8 weeks prior to inclusion.  
 
ExclusionCriteria 
Details  1. Severe comorbid psychiatric conditions such as high suicide risk (as determined by SCID-CV screening questions on suicidality), severe major depression, psychosis, bipolar disorder, substance dependence (other than tobacco);
2. Clinically determined Intellectual or other developmental disability that may compromise the ability to consent and participate in CBT;
3. Having received CBT of at least 10 sessions for OCD in the past year. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in total score of Yale-Brown Obsessive Compulsive Scale which assess Obsessive compulsive symptom severity.  Outcome assessments will be done by independent assessors who will be blind to the allocation. The primary end-point of the study will be after the intervention (Three months of intervention in both groups). The primary outcome in both groups will be assessed every two weeks during the intervention and one month and six months of follow-up. This would enable us to evaluate the rapidity and the sustainability of response.  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of total score on Montgomery-Ã…sberg Depression Rating Scale which assess severity of depression.   Baseline, post intervention, one month & 6 month follow ups will be used the time point for assessing patients level of depression by using Montgomery-Ã…sberg Depression Rating Scale. 
Reduction of total score on Hamilton Anxiety Rating Scale will be secondary outcome variable.   Baseline, post intervention, one month & six month follow ups will be considered the time point for assessing patients level of level of Anxiety using Hamilton Anxiety Rating Scale. 
Improvement in the Global Assessment of Functioning & World Health Organization Quality of Life-Brief scores will be the outcome variable.   Baseline, post-intervention, one-month, & six-month follow-up will be used as time points for the assessment of functioning & quality of life using the Global Assessment of Functioning & World Health Organization Quality of Life-Brief. 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3 
Date of First Enrollment (India)   15/07/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   Cognitive behavior therapy (CBT) is the first line of treatment for OCD. With a limited number of trained therapists and the majority working in megacities, a large chunk of the population has difficulties accessing standard first-line treatment; this gap may be bridged by using Video conference-based CBT (v-CBT). V-CBT may be a flexible, cost-effective treatment easily applicable to people far from megacities. The present study will answer whether v-CBT is non-inferior to in-person CBT for OCD. The study’s primary objective is to test the efficacy of v-CBT compared to in-person CBT in reducing the severity of OCD. 
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