Psychological StressNCT04752839
Evaluation of the Psychosocial Impact on Health Professionals Exposed During COVID 19 Coronavirus Pandemic
An observational study of Psychological Stress and Psychosocial Impairment, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychological Stress, Psychosocial Impairment, Anxiety
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2021to May 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is made up of workers from the Hospital de la Santa Creu i Sant Pau.
Who may be able to join
- Workers during COVID 19 pandemic at Hospital de la Creu i Sant Pau
Who cannot join
- No Exclusion Criteria, only the negative to participate
Trial locations and contacts
1 site in 1 country.
Carla Domínguez, MD contact
About this study
Official title: Evaluation of the Psychosocial Impact on Health Professionals Exposed During the COVID 19 Coronavirus Pandemic
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
- Keywords
- Covid 19, Healthcare workers, Mental health
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Coronavirus Infections, COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed Workers | Workers who have been exposed during COVID 19 pandemic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752839
- Sponsor's protocol ID
- IIBSP-COV-2020-40
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14993174Maunder 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.
PubMed 12743065Zhu 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.
PubMed 31978945Li 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.
PubMed 31995857Lai 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.
PubMed 32202646Spitzer 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.
PubMed 16717171Garcia-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.
PubMed 20089179Fernandez-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.
PubMed 22172961Bastien 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.
PubMed 11438246Diez-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.
PubMed 11485122Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Remor 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.
PubMed 16673626Báguena 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychosocial Impact on Health Professionals Exposed During the COVID 19 Coronavirus Pandemic
- ClinicalTrials.gov ID
- NCT04752839
- Acronym / sponsor ID
- IIBSP-COV-2020-40
- Conditions
- Psychological Stress, Psychosocial Impairment, Anxiety, Depression, Post Traumatic Stress Disorder, Coronavirus Infection
- Keywords
- Covid 19, Healthcare workers, Mental health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposed Workers | – | –Workers who have been exposed during COVID 19 pandemic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is made up of workers from the Hospital de la Santa Creu i Sant Pau.
Key inclusion criteria (1 listed)
- Workers during COVID 19 pandemic at Hospital de la Creu i Sant Pau
Key exclusion criteria (1 listed)
- No Exclusion Criteria, only the negative to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 14993174Nickell 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.
- Background: PubMed 12743065Maunder 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.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 31995857Li 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.
- Background: PubMed 32202646Lai 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 20089179Garcia-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.
- Background: PubMed 22172961Fernandez-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.
- Background: PubMed 11438246Bastien 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.
- Background: PubMed 11485122Diez-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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 16673626Remor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Domínguez, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress and Psychosocial Impairment, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio P Pérez, MD (678223410, sperezga@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Anxiety Disorder (GAD7) score. (time frame: Through study completion, an average of 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752839, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.