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CTRI Number  CTRI/2024/08/072909 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Therapist-aided App for Exposure and Response Prevention in patients with Obsessive-Compulsive Disorder 
Scientific Title of Study   Effectiveness, efficacy, and feasibility of a therapist-aided app for Exposure and Response Prevention: A Parallel-group, Pilot Randomised Control 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  Swati Kedia Gupta 
Designation  Assistant Professor, Clinical Psychology 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 4096, 4th Floor, Department of Psychiatry, Academic Block, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810140324  
Fax    
Email  swatikedia@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Swati Kedia Gupta 
Designation  Assistant Professor, Clinical Psychology 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 4096, 4th Floor, Department of Psychiatry, Academic Block, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810140324  
Fax    
Email  swatikedia@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Swati Kedia Gupta 
Designation  Assistant Professor, Clinical Psychology 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 4096, 4th Floor, Department of Psychiatry, Academic Block, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810140324  
Fax    
Email  swatikedia@aiims.edu  
 
Source of Monetary or Material Support  
IHUB Anubhuti-IITD Foundation (IHUB)  
 
Primary Sponsor  
Name  IHUB Anubhuti-IITD Foundation (IHUB)  
Address  G B Pant Polytechnic Extension, Okhla Phase III, Delhi-110020, South Delhi, India 
Type of Sponsor  Research institution 
 
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 Swati Kedia Gupta  All India Institute of Medical Sciences  Room No. 140, Digital Psychiatry Room, Psychiatry OPD, first floor, A-wing, New Rajkumari Amrit Kaur OPD, Ansari Nagar
South
DELHI 		 9810140324

swatikedia@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences  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 
Comparator Agent  Bilingual co-therapist Exposure and Response Prevention App   In the second arm, patients with OCD will also be given access to the app along with weekly session for 4 weeks (total 4 sessions) with the therapist who would be delivering manual-based ERP. The app would act as a co-therapist and help the patient in completing homework between sessions, provide psychoeducation and reminders and track anxiety.  
Intervention  Exposure and Response Prevention (ERP)  A trained therapist would provide weekly sessions for 4 weeks (total 4 sessions) of manual-based ERP sessions to patients diagnosed with Obsessive Compulsive Disorder.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Age between 18-40 years
2.Meeting diagnostic criteria for Obsessive Compulsive Disorder and per International Classification of Diseases-tenth edition (ICD-10)
3.Duration of illness≥ 2 years
4.Having access to smartphone
5.Able to read English and Hindi 
 
ExclusionCriteria 
Details  1. OCD with predominantly obsessions (without compulsions)
2.Depressive disorder with scores on Beck Depressive Inventory (BDI-II)≥ 14
3.Current active suicidal ideations
4.Patients with comorbid or history of severe mental illness such as schizophrenia, Bipolar affective disorder, Intellectual disability or Autism spectrum disorders
5.Patients with organic brain disorder or other neurological conditions
6.Unwilling or unable to provide consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure would be considered as the change in client adherence to homework of ERP therapy as assessed by Patient EX/RP Adherence Scale (PEAS).  1 week after the first session, week 2 (2nd session), week 3 (3rd session) and 4 weeks (4th session) 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome would be measured by the change in OCD symptoms as measured by decrease in Y- BOCS score  Baseline (Day 0) and Session 4 (Day 28) 
The secondary outcome would be measured by the change in OCD symptoms as measured by decrease in Clinicial Global Impression (CGI) score  Baseline (Day 0) and Session 4 (Day 28) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/10/2024 
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)   Not Applicable 
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 - 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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swatikedia@aiims.edu].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-07-2029?
    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   It is pilot, parallel-group randomised trial to assess the efficacy, feasibility and acceptability of adding a bilingual Exposure and Response Prevention App to usual standard of care, ie, Exposure and Response Prevention for patients diagnosed with obsessive compulsive disorder (OCD). The rationale for developing the app has been the difficulty patients face in completing homework sessions between sessions, which are essential to promote recovery and decrease symptom severity. The app aims to provide psychoeducative material on OCD and ERP; give personalised reminders to complete HW everyday and track the level of anxiety. 
Patients meeting the inclusion/exclusion criteria would be randomized into one of the two groups. The first group would be TAU/Standard care, wherein a trained clinical psychologist would take ERP sessions once in a week. The second group would get access to the bilingual, therapist- enhanced ERP app, along with weekly ERP sessions by the clinical psychologist. The clinical psychologist would be regularly supervised by SKG.In both the groups, ERP would follow a module-based approach to ensure consistency. To assess treatment fidelity, 20% of the sessions in both the groups would be recorded (while ensuring confidentiality) and reviewed by either SKG or KSD and rated on a Likert scale of 0 (not matching the module) to 10 (complete fit to the module). Both groups would go through baseline assessments that would include socio-demographic and clinical profile, CGI, and Y-BOCS. After every session, the therapist would fill the Patient EX/RP Adherence Scale (PEAS). Y-BOCS would be administered again at the end of the 4th session. The assessment at the end-of-intervention would be conducted by a Clinical Psychologist/Psychiatrist blinded to the randomization. 

Participant dropouts will be managed by implementing a reminder system. In the event that a participant misses a session, a reminder will be issued via phone call. If a participant misses only one session, their latest recorded data will be carried forward, allowing them to remain enrolled in the study. However, if a participant misses two or more sessions, they will be classified as dropout from the study. This approach aims to maintain participant engagement and data continuity by accommodating occasional absences while ensuring that consistent participation is upheld for the integrity of the study results.

Adequate measures would be taken for data safety. 

 
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