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CTRI Number  CTRI/2024/08/072748 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Behavioral 
Study Design  Other 
Public Title of Study   A multicentric implementation research study for integration of screening and management of mental and substance use disorders with non communicable diseases.  
Scientific Title of Study   ICMRs Multistate Implementation Research Study on Integration of Screening and Management of Mental and Substance Use Disorders with other Non Communicable Diseases  
Trial Acronym  ICMR MINDS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Dahiya 
Designation  Program Officer 
Affiliation  Indian Council of Medical Research 
Address  Division of Delivery Research, Indian Council of Medical Research Headquarters, Government of India, New Delhi

South
DELHI
110029
India 
Phone  9968910438  
Fax    
Email  neha.dahiya@icmr.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Dahiya 
Designation  Program Officer 
Affiliation  Indian Council of Medical Research 
Address  Division of Delivery Research, Indian Council of Medical Research Headquarters, Government of India, New Delhi

South
DELHI
110029
India 
Phone  9968910438  
Fax    
Email  neha.dahiya@icmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Neha Dahiya 
Designation  Program Officer 
Affiliation  Indian Council of Medical Research 
Address  Division of Delivery Research, Indian Council of Medical Research Headquarters, Government of India, New Delhi

South
DELHI
110029
India 
Phone  9968910438  
Fax    
Email  neha.dahiya@icmr.gov.in  
 
Source of Monetary or Material Support  
Monetary Support - Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V.Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anindo Majumdar  All India Institute of Medical Sciences (AIIMS)  Saket Nagar Bhopal Madhya Pradesh 462020
Bhopal
MADHYA PRADESH 		 9487635186

anindo.cfm@aiimsbhopal.edu.in 
Dr Arpit Parmar  All India Institute of Medical Sciences (AIIMS)  Room 125, 1st floor, Department of Psychiatry, AIIMS Bhubaneswar, Bhubaneswar 751019
Khordha
ORISSA 		 9868410675

dr.arpitparmar@gmail.com 
Dr Limalemla Jamir  All India Institute of Medical Sciences (AIIMS)  2nd floor, Department of Community and Family Medicine, Medical College Building, AIIMS Guwahati, Changsari Guwahati 781101
Kamrup
ASSAM 		 9914104152

limajamir@aiimsguwahati.ac.in 
Dr Yatan Pal Singh Balhara  All India Institute of Medical Sciences (AIIMS)  4080 C, 4th floor, Department of Psychiatry, AIIMS Teaching Block, Ansari Nagar, New Delhi 110029
South
DELHI 		 9868976365

ypsbalhara@gmail.com 
Dr Ajay Chauhan  Gujarat Institute of Mental Health  Superintendent Office, 1st floor, OPD Building, Hospital for Mental Health, Shahibag Ahmedabad Gujarat 380004
Ahmadabad
GUJARAT 		 9825611889

drajaypc@gmail.com 
Dr Debashish Basu  Post Graduate Institute of Medical Education and Research (PGIMER)  Department of Psychiatry, 3rd floor, Cobalt Block, Nehru Hospital, PGIMER, Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 9876826618

db_sm2002@yahoo.com 
Dr Johnson Pradeep R  St. Johns Medical College Hospital  Dr Johnson Pradeep Cubicle, 2nd floor, B-Block, St Johns Medical College Hospital, Bengaluru, Karnataka- 560034
Bangalore
KARNATAKA 		 7892673938

johnson.pr@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee Hospital for Mental Health Ahmedabad  Approved 
IEC AIIMS Guwahati  Approved 
Institute Ethics Committee for Biomedical and Health Research AIIMS Delhi  Approved 
Institutional Ethics Committee AIIMS Bhubaneswar  Approved 
Institutional Ethics Committee for Biomedical and Health Research PGIMER Chandigarh  Approved 
Institutional Ethics Committee St Johns Medical College Hospital Bengaluru  Approved 
The Institutional Human Ethics Committee of AIIMS Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Development of a Digital platform/ App  This intervention focuses on digitizing screening tools and developing referral and management protocols. 
Intervention  Integrated screening tools for mental health conditions (depression, anxiety, psychosis, alcohol use disorders and tobacco use disorders)  Integrated screening tools for mental health conditions are a targeted intervention designed to identify a range of mental health issues, including depression, anxiety, psychosis, alcohol use disorders, and tobacco use disorders. This approach utilizes specific screening tools (workflow) to be administered by Community Health Officers (CHOs). 
Comparator Agent  NIL  NIL 
Intervention  Patient education and engagement to raise awareness and promote shared decision-making.  This intervention aims to educate patients and engage them in their care process.  
Intervention  Training programs for healthcare providers on integrated care practices.  This intervention includes training programs for various healthcare providers. 
Intervention  Treatment guidelines and pathways that integrate mental health interventions within NCD care.  This intervention focuses on capacity building and use of workflows developed by the Indian Council of Medical Research (ICMR). These evidence-based workflows are designed for the screening/diagnosis and treatment of mental health conditions within the NCD care framework. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Persons of age 18 years and above, being screened for Non-communicable diseases (NCDs) or diagnosed with NCD.
2. Patients coming for screening or continued treatment of NCD at Health and Wellness Centers (HWC), Primary Health Care Centers (PHCs), Community Health Centers (CHCs), district hospitals, and tertiary care hospitals.
 
 
ExclusionCriteria 
Details  Patients with communicable diseases and age group lesser than 18 years. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients screened for mental health disorders among those screened/confirmed NCD (N+M)
2. Proportion of screened positive/confirmed for mental health disorders managed appropriately and effectively, are under follow up, complied with referral, compliance with treatment
 		 Three years 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessing the proportion of facilities who started integrating the model.
2. Estimation of incremental cost of the implementation of the model.
 		 Three years 
 
Target Sample Size   Total Sample Size="560"
Sample Size from India="560" 
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)   25/08/2024 
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)   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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  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 [neha.dahiya@icmr.gov.in].

  6. For how long will this data be available start date provided 10-08-2024 and end date provided 10-08-2029?
    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 - As it is a multicentric trial, additional information plan/policy for sharing IPD will be taken care by ICMR office bearers
Brief Summary   The aim of the study is to develop and implement a service delivery model that ensures at least 70% coverage for screening, care linkage, and management of priority mental disorders among NCD patients in public health facilities. The study will use a multi-site, quasi-experimental design with mixed methods, incorporating iterative improvement cycles. The implementation model based on the findings of the formative research work will be optimized using the Consolidated Framework for Implementation Research (CFIR), will integrate mental health services into NCD care. 
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