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

NCT04752839 | Unknown

• 1 other identifier: IIBSP-COV-2020-40
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Psychosocial Impairment; Anxiety; Depression; Post Traumatic Stress Disorder; Coronavirus Infection; COVID

Keywords

Covid 19; Healthcare workers; Mental health

Outcome Measures

Primary Outcomes (5)

• General Anxiety Disorder (GAD7) score.

  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.

  Through study completion, an average of 1 year.

• Insomnia severity Index (ISI)

  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

  Through study completion, an average of 1 year.

• Patient Health Questionaire (PHQ-9)

  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

  Through study completion, an average of 1 year.

• Perceived Stress Scale

  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.

  Through study completion, an average of 1 year.

• Impact of Event Scale Revised (IES-R)

  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.

  Through study completion, an average of 1 year.

Study Arms (1)

Exposed Workers

Workers who have been exposed during COVID 19 pandemic.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (13)

• Nickell LA, Crighton EJ, Tracy CS, Al-Enazy H, Bolaji Y, Hanjrah S, Hussain A, Makhlouf S, Upshur RE. Psychosocial effects of SARS on hospital staff: survey of a large tertiary care institution. CMAJ. 2004 Mar 2;170(5):793-8. doi: 10.1503/cmaj.1031077.

  PMID: 14993174 BACKGROUND

• Maunder R, Hunter J, Vincent L, Bennett J, Peladeau N, Leszcz M, Sadavoy J, Verhaeghe LM, Steinberg R, Mazzulli T. The immediate psychological and occupational impact of the 2003 SARS outbreak in a teaching hospital. CMAJ. 2003 May 13;168(10):1245-51.

  PMID: 12743065 BACKGROUND

• Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

  PMID: 31978945 BACKGROUND

• Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

  PMID: 31995857 BACKGROUND

• Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

  PMID: 32202646 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.

  PMID: 20089179 BACKGROUND

• Fernandez-Mendoza J, Rodriguez-Munoz A, Vela-Bueno A, Olavarrieta-Bernardino S, Calhoun SL, Bixler EO, Vgontzas AN. The Spanish version of the Insomnia Severity Index: a confirmatory factor analysis. Sleep Med. 2012 Feb;13(2):207-10. doi: 10.1016/j.sleep.2011.06.019. Epub 2011 Dec 14.

  PMID: 22172961 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.

  PMID: 11485122 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.

  PMID: 16673626 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Coronavirus Infections; COVID-19; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction

Central Study Contacts

Sergio P Pérez, MD

CONTACT

678223410; sperezga@santpau.cat

Carla Domínguez, MD

CONTACT

cdominguezg@santpau.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)