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Evaluation of the Psychosocial Impact on Health Professionals Exposed During COVID 19 Coronavirus Pandemic

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ClinicalTrials.gov Identifier: NCT04752839
Recruitment Status : Not yet recruiting
First Posted : February 12, 2021
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
Application of a survey in electronic support to hospital professionals. This survey will include different demographics as well as questions from own elaboration about the different aspects related to the development of work during the health emergency. A third part will be included different validated scales for screening / diagnosis of different problems that can present those who are working in the Current situation. The different scales are the PHQ-9, GAD 7, ISI, and EIE-R. These scales address the different problems that have been seen that can introduce professionals, Depression, Anxiety, Insomnia and adaptation to stressors.

Condition or disease
Psychological Stress Psychosocial Impairment Anxiety Depression Post Traumatic Stress Disorder Coronavirus Infection COVID

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Evaluation of the Psychosocial Impact on Health Professionals Exposed During the COVID 19 Coronavirus Pandemic
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Exposed Workers
Workers who have been exposed during COVID 19 pandemic.



Primary Outcome Measures :
  1. General Anxiety Disorder (GAD7) score. [ Time Frame: Through study completion, an average of 1 year. ]

    This instrument has been created to serve as a screening in anxiety disorder widespread. It is composed of 7 Likert-type response items from 0 to 3 that include the symptoms and the disability associated with the disorder.7 For its correction, a total score is obtained from the sum of scores of all the items, which can range from 0 to 21.

    There are no established cut-off points for the Spanish version. In the original version, the authors propose a cut-off point of greater than or equal to 10. The version validated for the Spanish population will be used.


  2. Insomnia severity Index (ISI) [ Time Frame: Through study completion, an average of 1 year. ]

    The investigators will use the adaptation of Fernández Mendoza et al. It is made up of 7 items that evaluate the nature, severity and impact of insomnia. It is answered with a Likert-type scale that goes from 0 to 4, taking into account the last month.

    For its correction, a total score is obtained that ranges between 0 and 28. The proposed cut-off points of the original version are:

    • 0-7: no insomnia
    • 8-14: insomnia below the threshold
    • 15-21: clinical insomnia of moderate severity
    • 22-28: severe clinical insomnia

  3. Patient Health Questionaire (PHQ-9) [ Time Frame: Through study completion, an average of 1 year. ]

    This instrument is intended to aid the diagnosis of depression through the DSM-IV criteria, and to determine the severity of said disorder. It can also be used to observe the changes experienced by patients over time.

    It is made up of 9 items with Likert-type responses with values between 0 and 3 that refer to the last two weeks.

    For its correction, a total score is obtained that ranges between 0 and 27. The proposed cut-off points are:

    • 1-4: minimal depression
    • 5-9: mild depression
    • 10-14: moderate depression
    • 15-19: moderately severe depression
    • 20-27: severe depression The version validated for the Spanish population will be used

  4. Perceived Stress Scale [ Time Frame: Through study completion, an average of 1 year. ]

    The Perceived Stress Scale provides an overall measure of perceived stress in the last month evaluating the degree to which life situations are valued as stressful by people. 12 Specifically: the degree of subjective control over unpredictable or unexpected situations and the discomfort that accompanies the perceived lack of control. Originally it consists of 14 items (some of which are formulated in negative).

    Two dimensions have been considered (control and loss of control) although more restrictive criteria would require considering the one-dimensionality of the scale.

    The validated Spanish version will be used.


  5. Impact of Event Scale Revised (IES-R) [ Time Frame: Through study completion, an average of 1 year. ]
    This scale is conceptually based on Horowitz's two-factor theory and assesses the subjective discomfort that accompanies traumatic experiences. It is a self-administered scale, and consists of 22 items in the revised version. 7 items value intrusion 8 avoidance and 7 hyperactivation. The investigators will evaluate the post-traumatic stress symptomatology, and for that, the revised version in Spanish will be used.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is made up of workers from the Hospital de la Santa Creu i Sant Pau.
Criteria

Inclusion Criteria:

  • Workers during COVID 19 pandemic at Hospital de la Creu i Sant Pau

Exclusion Criteria:

  • No Exclusion Criteria, only the negative to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752839


Contacts
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Contact: Sergio P Pérez, MD 678223410 sperezga@santpau.cat
Contact: Carla Domínguez, MD cdominguezg@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications:
Báguena M, Villarroya E, Beleña Á, Díaz A, Roldán C, Reig R. Propiedades Psycometricas de la Version Española de la Escala Revisionada de Impacto del Estresor (EIE-R). Anal y Modif Conduct. 2001;27(1997):581-604.

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT04752839    
Other Study ID Numbers: IIBSP-COV-2020-40
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Covid 19
Healthcare workers
Mental health
Additional relevant MeSH terms:
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Coronavirus Infections
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress, Psychological
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases