NCT04715477

Brief Summary

It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

First Submitted

Initial submission to the registry

January 15, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 15, 2021

Last Update Submit

January 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • intensive care Anxiety

    Hospital Anxiety Depression scale

    3 month

Study Arms (1)

Hospital Anxiety Depression Measure

Hospital Anxiety Depression Measure

Behavioral: Hospital Anxiety Depression Measure

Interventions

Hospital Anxiety Depression Measure

Hospital Anxiety Depression Measure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Co-operative patients over 18 years of age, with COVID PCR + admission to intensive care unit, will be included in the study.

You may qualify if:

  • Above 18 years old
  • COVID PCR +,
  • admitted to intensive care,
  • conscious, cooperative patients

You may not qualify if:

  • Having hearing and speaking problems,
  • Can't speak Turkish or English,
  • who do not have the cognitive level to understand and answer the questions,
  • Communication problems such as dementia and Alzheimer's,
  • patients receiving sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlke Küpeli

İzmit, Kocaeli̇, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90-111. doi: 10.1111/nyas.14506. Epub 2020 Oct 2.

  • Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, Zandi MS, Lewis G, David AS. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry. 2020 Jul;7(7):611-627. doi: 10.1016/S2215-0366(20)30203-0. Epub 2020 May 18.

  • 3. Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlik Güvenilirlik Çalışması. Türk Psikiyatri Dergisi 1997;8:280-287.

    RESULT
  • Kupeli I, Kara MY, Yakin I, Caglayan AC. Anxiety and depression in the first 24 h in COVID-19 patients who underwent non-invasive mechanical ventilation in the intensive care unit. Ir J Med Sci. 2022 Oct;191(5):2291-2295. doi: 10.1007/s11845-021-02808-8. Epub 2021 Oct 19.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • ilke kupeli

    Derince Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof.

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

January 17, 2021

Primary Completion

April 1, 2021

Study Completion

April 15, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations