| CTRI Number |
CTRI/2025/02/080380 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To estimate the economic impact of suicide and suicide attempts in India |
|
Scientific Title of Study
|
Economic Burden of Suicide and Suicide Attempts in India: Estimation from a Societal Perspective |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Jain |
| Designation |
Research Fellow |
| Affiliation |
Indian Law Society |
| Address |
Centre For Mental Health Law and Policy Law College Road Pune Law College Road, Erandwane, Pune Pune MAHARASHTRA 411027 India |
| Phone |
9074770345 |
| Fax |
|
| Email |
jain2009nikhil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Animesh Patel |
| Designation |
HOD, Psychiatry Department |
| Affiliation |
Civil Hospital Mehsana |
| Address |
Civil Hospital near ISBT Mehsana
Mahesana GUJARAT 384001 Other |
| Phone |
|
| Fax |
|
| Email |
dr.animeshpatel87@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nikhil Jain |
| Designation |
Research Fellow |
| Affiliation |
Indian Law Society |
| Address |
Centre For Mental Health Law and Policy Law College Road Pune Law College Road, Erandwane, Pune Pune MAHARASHTRA 411027 India |
| Phone |
9074770345 |
| Fax |
|
| Email |
jain2009nikhil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support by Civil Hospital Mehsana and Lions Hospital, Mehsana ( Department of Psychiatry) Mehsana 384001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Nikhil Jain |
| Address |
CAPHRI Maastricht University The Netherlands |
| Type of Sponsor |
Other [University ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Animesh Patel HOD Department of Psychiatry |
Mehsana Civil hospital , Near ISBT, & Lions Hospital, Mehsana, Gujarat |
Department Of Psychiatry, Civil Hospital, Near ISBT, Mehsana, Gujarat & Lions Hospital( Department of Psychiatry Link Road Mehsana 384001 India Mahesana GUJARAT |
8238011270
dr.animeshpatel87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Law Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T148||Other injury of unspecified body region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study will involve patients admitted to the emergency department, ICU, or other hospital units following a suicide attempt. In situations where the individual who attempted suicide is too unwell to participate in the study or is a minor (below 18 years of age), a close family caregiver will be engaged to provide information about the resources consumed and utility loss (health-related quality of life) |
|
| ExclusionCriteria |
| Details |
People who cannot understand the local language |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Economic burden of suicide and suicide attempts |
Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health-related quality of life |
Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up |
|
|
Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
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)
|
27/02/2025 |
| 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="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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [n.jain@maastrichtuniversity.nl].
- For how long will this data be available start date provided 27-02-2027 and end date provided 27-02-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| This study aims to quantify the economic burden of suicide and suicide attempts in India, focusing on the societal costs associated with these events. Recognizing the limitations of existing gross costing methods, which often overlook sector-specific impacts, the study introduces a tailored Resource-Use Measure (RUM) instrument to capture granular costs across sectors such as healthcare, law enforcement, and patient and family and their productivity losses. Additionally, it incorporates a Health-Related Quality of Life (HRQoL) assessment using EuroQOL (EQ-5D-5L) to account for utility loss among suicide attempt survivors. The study adopts a retrospective, incidence-based design and employs advanced statistical approaches, including nonparametric tests for subgroup cost comparisons and Generalized Linear Mixed Models (GLMMs) for longitudinal data analysis. Bootstrapping and sensitivity analyses will ensure the robustness of the findings. By identifying major cost drivers such as displaced time and opportunity costs, this research provides a comprehensive understanding of the multifaceted economic impacts of suicide. The findings will inform data-driven policymaking and guide resource allocation for public health funding in suicide prevention efforts. Dissemination plans include peer-reviewed journal publications, with all data anonymized and stored in adherence to ethical guidelines. | |