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CTRI Number  CTRI/2025/09/094217 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Feasibility and efficacy of concentrated ERP in patients with OCD 
Scientific Title of Study   Feasibility and efficacy of concentrated Exposure and Response Prevention therapy in patients with OCD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ridhima Bassi 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology, Dr MV Govindswammy building, National Institute of Mental Health and Neurosciences, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9479388640  
Fax    
Email  ridhimabassi19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ajay Kumar 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology, Dr MV Govindswammy building, 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  Ridhima Bassi 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology, Dr MV Govindswammy building, National Institute of Mental Health and Neurosciences, Bengaluru


KARNATAKA
560029
India 
Phone  9479388640  
Fax    
Email  ridhimabassi19@gmail.com  
 
Source of Monetary or Material Support  
Junior Research Fellowship, UGC, Bahadur Shah Zafar Marg, New Delhi, India, Pin code: 110002 
 
Primary Sponsor  
Name  University Grants Commission 
Address  Bahadur Shah Zafar Marg, New Delhi, 110002 
Type of Sponsor  Government funding agency 
 
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 Ajay Kumar  National Institute of Mental Health and Neurosciences, Bengaluru  Outpatient and inpatient services of department of Psychiatry, Behavior Medicine Unit, NIMHANS, Hosur Road, Bengaluru, Karnataka, 560029
Bangalore
KARNATAKA 		 9886426548

ajaycog2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC (Behavioral Science Division), NIMHANS  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Concentrated Exposure and Response Prevention Therapy  Psychological intervention for Obsessive-Compulsive Disorder (OCD) and other anxiety disorders, where treatment is delivered in an intensive, condensed format over a short period, often several consecutive days, rather than weekly sessions. This Concentrated Exposure Therapy allows patients to confront fears and resist compulsions for prolonged periods with therapist-assisted guidance, leading to demonstrated effectiveness and patient acceptance for treating OCD. The total duration of the intervention is one month including 4 consecutive therapist assisted exposures followed by 3 sessions per week for monitoring self-assisted exposures. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients meeting the primary diagnosis of Obsessive Compulsive Disorder as per the diagnostic criteria of ICD-11. Y-BOCS score ranging from 16-31 (moderate-severe range) and a CGI score of 4 to 6 (moderately ill to severely ill). Able to comprehend and understand spoken English and Hindi. Patients that are drug-naive or stabilized on medication for 8 weeks prior to the inclusion in the study.
 
 
ExclusionCriteria 
Details  Severe comorbid psychiatric conditions such as high suicide risk (as determined by FLII-11), severe major depression with psychotic features, psychosis, bipolar disorder, substance dependence (other than tobacco), severe personality disorder;
Clinically determined Intellectual or other developmental disability (autism) that may compromise the ability to consent and participate in CBT; Patients with any past medical history of cardiac or pulmonary issues or hypertension. Women who are pregnant will also be excluded.
Patients who have received more than three sessions of CBT for OCD in the previous year.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in severity of OCD symptoms   Reduction in severity of OCD symptoms across 4 time points i.e. at baseline, 1 week, 3 weeks and 3 months post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in anxiety & depressive symptoms   3 time points i.e. at baseline, 3 weeks & 3 months post intervention 
cost-effectiveness of concentrated Exposure & Response Prevention Therapy  3 time points i.e. at baseline, 3 weeks & 3 months post intervention 
The role of distress tolerance, self-efficacy, & patient’s adherence to homework as predictors of outcome in concentrated ERP.  3 time points i.e. at baseline, 3 weeks & 3 months post intervention 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   15/09/2025 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ridhimabassi19@gmail.com].

  6. For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Feasibility and efficacy of concentrated Exposure and Response Prevention Therapy in patients with Obsessive Compulsive Disorder

Single-group repeated measures design with four assessments for the primary outcome variable  (baseline, 1-week, 4-weeks post-treatment, and 3-month follow-up). Participants will be recruited from the outpatient and inpatient services of NIMHANS, Bengaluru (Behavioral Medicine Unit, OCD Clinic, NCWB). The sample size estimated is 26 patients with moderate-to-severe OCD.

Intervention
Concentrated Exposure and Response Prevention Therapy (ERP) to be delivered in an intensive short-term format over a period of one month.

Primary Objective

Assess the feasibility of concentrated ERP in patients with OCD and to evaluate the efficacy of concentrated ERP in reducing OCD symptom severity (Y-BOCS assessed by independent rater).

Secondary Objectives

Compare cost-effectiveness with published data on standard ERP.

Assess impact on anxiety, depression, and quality of life (HAM-A, HAM-D, EQ-5D).

Examine predictors of treatment outcome (distress tolerance, self-efficacy, homework adherence).

Procedure

The study will be conducted in two phases

1. Pilot phase

The researcher will finalize tools and receive permissions from the respective authors. She will receive training to handle any exacerbation of OCD symptoms while doing intensive ERP. Pilot testing will be done for 3 patients with OCD. Based on the outcome, the intervention will be revised, and the frequency and duration of sessions will be finalized.

2. Main phase

Potential participants will be approached for their participation in the study. Those meeting the inclusion criteria and giving informed consent will be assessed on baseline assessments. The content and format of intensive ERP will be thoroughly described to patients prior to inclusion in the study; they will be informed that the treatment will need their full attention and commitment. The finalized therapy module will be delivered. Assessments will be done pre, 1 week, and 4 weeks post-intervention and at a 3-month follow-up. YBOCS, PEAS/HCS measures will be repeated weekly.

Statistical Analysis Plan
Repeated measures ANOVA, Reliable Change Index for clinical significance, cost-effectiveness using Incremental Cost-Effectiveness Ratio (ICER).


 
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