| CTRI Number |
CTRI/2021/04/032873 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Feasibility Study |
| Study Design |
Other |
|
Public Title of Study
|
Global Mental Health Databank |
|
Scientific Title of Study
|
Global Mental Health Database (GMHD)- A Feasibility Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumitra Pathare |
| Designation |
Director |
| Affiliation |
Centre for Mental Health Law & Policy, Indian Law Society |
| Address |
Centre for Mental health, law and policy, ILS Law College, Law College Road, Erandawane, Pune, Maharashtra 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
spathare@cmhlp.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumitra Pathare |
| Designation |
Director |
| Affiliation |
Centre for Mental Health Law & Policy, Indian Law Society |
| Address |
Centre for Mental health, law and policy, ILS Law College, Law College Road, Erandawane, Pune, Maharashtra 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
spathare@cmhlp.org |
|
Details of Contact Person
Public Query
|
| Name |
Soumitra Pathare |
| Designation |
Director |
| Affiliation |
Centre for Mental Health Law & Policy, Indian Law Society |
| Address |
Centre for Mental health, law and policy, ILS Law College, Law College Road, Erandawane, Pune, Maharashtra 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
spathare@cmhlp.org |
|
|
Source of Monetary or Material Support
|
| The Wellcome Trust Limited- Funding Agency |
|
|
Primary Sponsor
|
| Name |
THE WELLCOME TRUST LIMITED |
| Address |
215 Euston Road, London NW1 2BE. (Wellcome) |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
South Africa
United Kingdom |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumitra Pathare |
India |
Centre for Mental Health Law and Policy, ILS Law College, Law College Road, Shivaji Nagar, Pune, Maharashtra 411004
Pune
MAHARASHTRA |
09370666191
spathare@cmhlp.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Law Society - Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
none |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Quantitative Arm:
1) Currently resides in India (/UK/South Africa-depending on the site)
2) Access to an Android phone
3) Reads and understands English
4) Decisional capacity to consent
Qualitative Arm:
1) Currently resides in India (/UK/South Africa-depending on the site)
2) Decisional capacity to consent
3) Lived experience of and/or interest in anxiety or depression as ascertained by an affirmative answer to any of the eligibility questions: a)Have you ever felt you could have benefited/did benefit from access to support for anxiety or depression? b)Have you witnessed or experienced anxiety or depression within your family or close friends? c)Do you have a strong interest in anxiety and/or depression? |
|
| ExclusionCriteria |
| Details |
Both Quantitative and Qualitative
1) Prisoners at the time of enrollment
2) Unable to follow study instructions
3) This study focuses on young adults. Adults 25 years and older will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the governance preference and governance acceptability of youth participating in a mental health databank. |
12 weeks survey journey for Quantitative arm; 1 time focus group session for Qualitative arm |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="4500"
Sample Size from India="1500"
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)
|
16/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Global Mental Health Database (GMHD) study is a collaborative effort of Sage Bionetworks, the Wellcome Trust and researchers from UK, India and South Africa. This is an observational, cross sectional, randomized, parallel group multiple arm trial, designed to evaluate the governance, technical, and scientific feasibility of developing a global mental health database of digital data collected from young adults (n=4500) using smart phones in three countries (India, South Africa, and the UK). This project aims to understand whether young adults are willing to share data regarding their mental health status and management with researchers. The overarching goals of the project are to, a) prototype and test mechanisms to successfully empower youth to be involved in data management, b) enable rapid and convenient data collection, c) identify the governance model that youth support to share their data with mental health scientists, and d) understand the factors affecting participation in the databank. To this end, the study has two arms, a quantitative arm and a qualitative arm. In the quantitative arm, participants will be recruited to pilot the GMHD mobile application, which is designed to collect mental health data for a global databank. Thus, through this arm, we will evaluate the technical, regulatory, and scientific feasibility of the databank approach. While, the qualitative arm explores, through deliberative democracy methodology, the attitudes of young adults with regard to data collection and other implementation issues for a databank. |