| CTRI Number |
CTRI/2020/12/029780 [Registered on: 14/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Mental health impact of COVID-19 pandemic on PMNS cohort |
|
Scientific Title of Study
|
Explaining Resilience and Vulnerability to the impact on mental health of the Covid-19 pandemic in the Pune Maternal Nutrition Study birth cohort |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishikesh V Behere |
| Designation |
DBT-Wellcome India Alliance Intermediate fellow |
| Affiliation |
Diabetes Unit |
| Address |
6th floor, Banoo Coyaji bldg, KEM Hospital Research Center
489, Rastapeth, Sardar Moodliar Road
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
rvbehere@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rishikesh V Behere |
| Designation |
DBT-Wellcome India Alliance Intermediate fellow |
| Affiliation |
Diabetes Unit |
| Address |
6th floor, Banoo Coyaji bldg, KEM Hospital Research Center
489, Rastapeth, Sardar Moodliar Road
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
rvbehere@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishikesh V Behere |
| Designation |
DBT-Wellcome India Alliance Intermediate fellow |
| Affiliation |
Diabetes Unit |
| Address |
6th floor, Banoo Coyaji bldg, KEM Hospital Research Center
489, Rastapeth, Sardar Moodliar Road
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
rvbehere@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural funds of Diabetes unit, KEMHRC Pune |
|
|
Primary Sponsor
|
| Name |
Diabetes Unit |
| Address |
Diabetes Unit, KEM Hospital Research Center
489, Rastapeth, Sardar Moodliar Road
Pune 411011
Maharashtra
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rishikesh Behere |
KEM hospital research center |
Diabetes Unit, 6th floor, Banoo Coyaji bldg, KEM Hospital Research Center
489, Rastapeth, Sardar Moodliar Road
Pune
MAHARASHTRA |
9449519078
rvbehere@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KEM Hospital Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental health concerns |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Participants of the PMNS cohort, who have undergone pre-pandemic psychological and mental health evaluation |
|
| ExclusionCriteria |
| Details |
Only those subjects who have the capacity to be interviewed will be included in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the COVID-19 pandemic experience of the participants of the cohort and the current level and nature of distress and mental health problems. |
single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparing the current mental health status and distress during the Covid-19 pandemic among participants of the cohort. (with reference to baseline status of chosen indicators of mental health and distress)
2. Analyzing relevant variables available for the cohort to determine their role in explaining vulnerability and resilience to distress and mental health problems.
|
Single time point |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
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)
|
26/12/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 COVID-19 pandemic and lockdown are significant stressful events (adversity) which have affected our everyday lives, and have led to many changes. These changes can affect some people more than others, impacting their mental wellbeing. The psychological impact of adversity is determined by many protective or predisposing factors that develop over the life of an individual. Pune Maternal Nutrition Study birth cohort is a community based cohort with serial measurements of various aspects of growth and development over the last 24 years. Pre-pandemic baseline data of their psychological evaluation and mental health status are available. This provides us with a unique opportunity to study the mental health impact of the pandemic (compared with baseline status). We would also be able to identify the various bio-psycho-social factors associated with vulnerability or resilience to mental health impact from the serial data available on this cohort over its life course. This would help identify people at risk for mental health impact of adversity and plan early interventions to reduce the mental health burden of the pandemic. |