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CTRI Number  CTRI/2025/02/080707 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Process of Care Changes
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Community Based Intervention to support mental health disorders among elderly 
Scientific Title of Study   Community Based Intervention for Common Mental Disorders (CMDs) among Slum-dwelling Urban Elderly to Promote Healthy Ageing 
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 Anushka Ghosh 
Designation  Post-Doctoral Research Fellow 
Affiliation  ICMR -Centre for Ageing and Mental Health 
Address  Block DP1, Sector V, Bidhannagar, Kolkata, West Bengal 700091

Kolkata
WEST BENGAL
91
India 
Phone  9836227184  
Fax    
Email  anushka.92428@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indranil Saha 
Designation  Scientist E (Medical) 
Affiliation  ICMR -Centre for Ageing and Mental Health 
Address  Block DP1, Sector V, Bidhannagar, Kolkata, West Bengal 700091

Kolkata
WEST BENGAL
91
India 
Phone  9830019016  
Fax    
Email  saha.indranil@icmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Anushka Ghosh 
Designation  Post-Doctoral Research Fellow 
Affiliation  ICMR -Centre for Ageing and Mental Health 
Address  Block DP1, Sector V, Bidhannagar, Kolkata, West Bengal 700091


WEST BENGAL
91
India 
Phone  9836227184  
Fax    
Email  anushka.92428@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Headquarters, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
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 
Anushka Ghosh  Kolkata Municipal Corporation Wards   Slum areas of KMC Wards
Kolkata
WEST BENGAL 		 9836227184

anushka.92428@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  depression, anxiety, post traumatic stress, quality of life, substance abuse 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community Based Intervention  The intervention will develop a culturally sensitive and contextually relevant strategy for improving mental health care among urban slum-dwelling elderly, using a co-design approach that involves health workers, community health volunteers (CHVs), caregivers, and elderly participants. It consists of two key components: first, modular training for CHWs and community support groups, including training sessions with a follow-ups, focusing on mental well-being, early screening for common mental disorders (CMDs), assessment skills, basic mental health support, medication management, and collaboration with mental health professionals. Second, training for beneficiaries and caregivers incorporating awareness campaigns, psychoeducation, communication skills training, and home-based care guidance to foster stigma reduction, encourage open dialogue, and enhance the caregiving abilities of family members. Additionally, the intervention will ensure accessibility through culturally tailored information, resources in local languages, and community engagement with volunteers and influential local figures to enhance responsiveness and inclusivity for elderly individuals with varying abilities. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Permanent resident of selected slum areas 
 
ExclusionCriteria 
Details  Individuals with any physical and/or mental disability 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Geriatric Depression, Geriatric Anxiety, Quality of Life  baseline, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Healthy Ageing  6 months 
 
Target Sample Size   Total Sample Size="372"
Sample Size from India="372" 
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)   17/03/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - NO
Brief Summary  

Background:

The rapid ageing of population presents unique challenges for the elderly individuals residing in financially strained areas such as urban slums, particularly in addressing CMDs. The combined effect of limited healthcare access, socioeconomic inequalities and environmental stressors exacerbates the mental health struggles faced by elderly residents of slums. Recognizing this, a community-based intervention becomes imperative to promote healthy ageing and address the specific needs of this vulnerable group.

Objective:

The primary aim of this research is to develop, implement and evaluate a community-based intervention targeting CMDs (includes depression and anxiety disorders) among urban elderly individuals residing in slums. The objective is to assess the burden and needs of CMDs, subsequently enhancing awareness, providing psychoeducation and building skills through modular training tailored to the unique socio-cultural context of slum settings, thereby fostering healthy aging. Additionally, the study aims to monitor the effectiveness of the intervention in mitigating mental health challenges.

Methods:

The research design will employ an embedded mixed-methods approach, combining quantitative assessments of CMDs prevalence with qualitative evaluations to identify specific mental health needs. The intervention development phase will include modular trainings for both elderly individuals and their community support groups. The study will be conducted using convenient sampling for slum settlement selection, cluster random sampling for intervention effectiveness assessment; and encompasses comprehensive data collection tools, including surveys, interviews and focus group discussions.

Expected Outcome:

Anticipated outcomes of the research encompass a tailored community-based intervention addressing CMDs among slum-dwelling urban elderly, improved mental health awareness, reduced stigma and enhanced overall well-being. The research aims to contribute evidence-based insights for effective mental health interventions in similar settings, ultimately fostering healthy ageing. 
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