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
|Condition or disease|
|Psychological Stress Psychosocial Impairment Anxiety Depression Post Traumatic Stress Disorder Coronavirus Infection COVID|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|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|
Workers who have been exposed during COVID 19 pandemic.
- 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.
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
|Contact: Sergio P Pérez, MDfirstname.lastname@example.org|
|Contact: Carla Domínguez, MDemail@example.com|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|