Effect of Covid-19 Affliction on Psychological and Mental... | NCT04746443

Studies
Effect of Covid-19 Affliction on Psychological and Mental Health Among College Going Students: Cross-Sectional Survey

NCT04746443

Sponsor

King Khalid University

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Covid19

Interventions

NOT APPLICABLE (NA)

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2020Actual

Primary Completion Date

Mar 8, 2021Estimated

Completion Date

Mar 8, 2021Estimated

First Submitted Date

Feb 8, 2021

First Submission Date that Met QC Criteria

Feb 8, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2021

Last Update Posted Date

Feb 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).

Detailed Description

Objective : To study the impact on psychological and mental health of COVID-19 affliction among college going students

Methodology:

Study Design: Cross-sectional Mode of implementation: Online surveys Population : COVID positive College students Inclusion criteria: Students positive to corona tests Exclusion criteria: students negative to corona tests

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STUDENTS		COLLEGE STUDENTS WITH POSITIVE COVID-19 TEST	Other: NOT APPLICABLE (NA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NOT APPLICABLE (NA)	Other	THE INTERVENTION GROUP IS NOT APPLICABLE TO THE CURRENT STUDY DESIGN	STUDENTS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EVENT IMPACT SCALE - REVISED	The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. It is a revised version of the older version, the 15-item IES (Horowitz, Wilner, & Alvarez, 1979). The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 DSM-IV symptoms of PTSD	Within 1 month of the impact of COVID-19

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Students positive for COVID-19 test -

Exclusion Criteria: Students negative for COVID-19 test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

College going students

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SNEHIL DIXIT, PHD	Contact	+966559105324		snehil@kku.edu.sa

Overall Officials

Name	Affiliation	Role
SNEHIL DIXIT, PhD	King Khalid University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Khalid University	Recruiting	Abhā	'Asir Region		Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

The Data cannot be shared without the prior approval of the University

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided