NCT04689464

Brief Summary

The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety. To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

December 26, 2020

Last Update Submit

June 6, 2021

Conditions

Keywords

COVID19AnxietyDepression

Outcome Measures

Primary Outcomes (2)

  • depression

    Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; \>20 severe. Minimum 0 maximum 27 points

    at the time of acute infection, average of 1 month

  • anxiety

    Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; \>15 severe. Minimum 0, maximum 21 points

    at the time of acute infection, average of 1 month

Study Arms (3)

mild covid

moderate covid

severe covid

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with covid19 diagnosed by their healthcare providers

You may qualify if:

  • \- patients with COVID19 willing to participate in the study

You may not qualify if:

  • unwilling unable to read or interact with standardized questionnaire unconscious

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlFayhaa Teaching hospital

Basra, 99999, Iraq

Location

MeSH Terms

Conditions

COVID-19Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Zainab N Abdul-nabi, M.Sc.

    University of Basrah

    STUDY DIRECTOR
  • Hiba Dawood, M.Sc.

    University of Basrah

    STUDY DIRECTOR
  • Qussay N Almaliki, Ph.D.

    AlFayhaa teaching hospital

    STUDY DIRECTOR
  • Nadheera F Neamah

    University of Basrah

    STUDY DIRECTOR
  • Dania Zydoon

    Al-Sader teaching hospital

    PRINCIPAL INVESTIGATOR
  • Zainab Mahdi

    Al-Mawani general hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Pharmacy Specialist

Study Record Dates

First Submitted

December 26, 2020

First Posted

December 30, 2020

Study Start

December 1, 2020

Primary Completion

May 28, 2021

Study Completion

June 1, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations