NCT04369300

Brief Summary

  1. 1.To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India
  2. 2.To understand correlation between COVID-19 related factors and mental health symptomology in the general population in India
  3. 3.Demographic Information Demographic variables included Gender, Age, Place of Stay, Marital Status, Highest Level ofEducation, current living arrangement (e.g. staying alone or with family) and Occupation. It further includesregular employment status and current employment status(e.g, Work from home, temporary leave, termination etc)
  4. 4.History of illness (Present or past) History of physical ailment specified (diabetes, hypertension, heart ailment or being on any steroid or any other chronic ailment) Previous history of H1N1/ Influenza like illness
  5. 5.COVID-19 Information This section includes time spent focusing on COVID related information, current stressors with respect to COVID-19 and coping mechanisms used. This further includesinformation on resources available to participants near their place of stay and information of any known diagnosed case of COVID-19.
  6. 6.Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9) Powered by

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

April 28, 2020

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence (magnitude) of anxiety of general adult population during COVID-19

    To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Generalized Anxiety Disorder Scale (GAD-7)

    1 YEAR

  • prevalence (magnitude) of depression and anxiety of general adult population during COVID 19

    To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Patient Health Questionnaire (PHQ-9).

    1 Year

Interventions

Observational Data Collection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants of the age of 18 years and above Participants residing in India Participants with minimum 10 years of education with basic knowledge of English

You may qualify if:

  • Participants of the age of 18 years and above
  • Participants residing in India
  • Participants with minimum 10 years of education with basic knowledge of English

You may not qualify if:

  • Participants under the age of 18 years
  • Participants residing outside of India
  • Participants with previous history of any major psychiatric illness, psychiatric hospitalization or currently on any psychiatric medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Super Speciality hospital

New Delhi, National Capital Territory of Delhi, 110017, India

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sameer Malhotra

    max healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 30, 2020

Study Start

April 24, 2020

Primary Completion

November 24, 2020

Study Completion

February 24, 2021

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations