NCT04552392

Brief Summary

Quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. However, it may create psychological, emotional, and financial problems for some persons. The experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched. In view of the increasing cases of COVID-19 in India and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. In India, no such study had been undertaken and our study thus filled the research gap. The cross-sectional observational study aims at assessing the psychological impact of quarantine on Indian BSF jawans (n=100). They would be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Scale, and Impact of Events Scale-Revised. A qualitative interview schedule will also be carried out. Data would be analysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

September 15, 2020

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • depression

    Beck Depression Inventory

    Baseline

  • anxiety

    State Trait Anxiety Inventory

    Baseline

  • perceived stress

    Perceived Stress Scale

    Baseline

  • impact of life events

    Impact of Events Scale-Revised

    Baseline

Interventions

No intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Jawana quarantined at Border Security Force Facility as a precautionary measure for COVID-19

You may qualify if:

  • Indian-origin adults between the age of 18-60 yrs quarantined at border security force facility
  • Both genders would be included

You may not qualify if:

  • Any chronic co-morbid medical condition
  • Current Diagnosis of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ITBP Chawala

Delhi, India

Location

Study Officials

  • Pragya Sharma, PhD

    Ram Manohar Lohia Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 17, 2020

Study Start

September 20, 2020

Primary Completion

October 20, 2020

Study Completion

October 20, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations