Clinical trial NCT04890665: Online Multi-component Psychological Intervention for Healthcare Workers During COVID-19 Pandemic
Official title: Effectiveness of a Self-applied Multi-component Psychological Online Intervention Based on User Experience, for Anxiety, Depression, Burnout, Fatigue Compassion on Healthcare Workers During the COVID-19 Outbreak: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Sleep Disturbance
Quality of Life
Burnout, Professional
Stress
Fatigue, Compassion
Lead sponsor: Universidad Internacional de Valencia
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Ciudad Juarez
name: University of Guadalajara
name: Universidad Nacional Autonoma de Mexico
name: Universidad Internacional del Ecuador
name: University of Buenos Aires
name: University of Valencia
First posted: 2021-05-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms, one is the experimental group that receives the treatment solely through the online platform, and the other is the comparison group that will receive treatment delivered through a therapist through video calls. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to carry out a randomized clinical trial with healthcare workers in Mexico through a web platform. The intervention aims to reduce anxiety, depressive symptoms, burnout, stress, compassion fatigue, and increase the quality of life and sleep and self-care, as well as improve skills in providing bad news to patients and their families. A self-applied intervention will be compared with an intervention delivered by therapists providing the same intervention implemented through Zoom, Skype, or Microsoft Teams, to ensure sanitary protection measures.

Detailed description: Recent studies indicate that a lack of personal protective equipment, an unreasonable amount of work, inadequate medications, fear of contracting the disease, spreading the disease to co-workers and family, and lack of qualified training, have put front-line healthcare workers with unimaginable stress. There are various psycho social stressors to which the person who is working in this line of action is exposed. Nurses have been found to be one of the most affected groups because they have manifested various psychological consequences, including anxiety, depression, and stress. Likewise, multiple studies have reported psychological discomfort in health workers, especially those who are in areas of care for patients infected by COVID-19, among the most frequent psychological consequences that have been found, high prevalence of anxiety, depression, stress, insomnia, and high levels of distress are observed. Some of the challenges faced by health personnel who are in contact with patients infected by the virus are having a higher risk of contagion, not having the necessary personal equipment to prevent contagion, excessive workload, and even neglecting activities basic. In addition to these unfavorable working conditions faced by COVID-19 front line care staff, there is a need to make complex decisions that can generate moral or ethical damage. Consequently, this situation can trigger a series of negative emotional alterations, such as anxiety, depression, post-traumatic stress disorder, and even suicidal ideas.

Due to the current restrictions derived from the pandemic, psychological digital interventions have been an effective option to overcome barriers in mental health care for this population. Likewise, this type of intervention can provide various benefits, such as carried out by different means and the efficacy that they have shown to treat a wide range of mental health problems.

The objective of this study is to carry out a randomized clinical trial through a web platform which will have two groups: 1) Self-applied intervention directed at health personnel from all over Mexico for the reduction of symptoms of anxiety, depression, burnout, stress, compassion fatigue and increased self-care, quality of sleep and perceived quality of life, as well as how to offer tools to acquire knowledge about how to notify bad news to patients and families. The contents of the online intervention will be implemented through a responsive web application. In order to create the most fitted intervention for the real needs of the participants will be created following the principles of User Experience, this ensuring that the design characteristics of the tool will meet the desired requirements to be perceived as easy to use, attractive and useful. The User Experience approach refers to the experience that a user has with a product, with special emphasis on human-product interaction.

2) The same intervention but implemented by a therapist via Zoom, Skype, or Teams to continue ensuring protection measures for both the therapist and the patient.

The subjective measures will include the following Psychometric instruments:

1. Post-traumatic diagnostic scale
2. Plutchik Suicide Risk Scale
3. Generalized Anxiety Scale.
4. The Center for Epidemiological Studies Depression Scale-Revised
5. Professional Quality of Life Measure
6. Pittsburgh Sleep Quality Index
7. Scale for measuring resilience with Mexicans
8. Appraisal of Self-care Agency
9. The Fear of COVID-19 Scale
10. Opinion on the treatment.
11. System usability scale

Eligibility criteria: Inclusion Criteria:

* To have access to a communication device with access to the internet (computer, tablet, and mobile)
* To have a valid email address.
* To have basic digital skills in the use of an operational system and internet browsing.
* To understand Spanish since all the contents are in this language.
* Symptoms of anxiety, depression, burnout, and fatigue compassion

Exclusion Criteria:

* To have a diagnosis of psychotic disorder
* To be receiving psychological and/or pharmacological treatment during the study
* Moderate to a high score on the suicide scale
* Recent attempt of suicide (3 months)
* To refuse to accept to participate

Primary outcomes:
measure: The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
measure: Decrease in the symptoms of General Anxiety Disorder (GAD-7)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
measure: Decrease in the score of The Pittsburgh Sleep Quality Index (PSQI).
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
measure: Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale (PSS)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
measure: Increase in the score of the Professional Quality of Life Measure (ProQOL)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
measure: Increase in the score of the Appraisal of Self-care Agency (ASA)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
Secondary outcomes:
measure: Decrease in the Plutchik Suicide Risk Scale (BSI)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
measure: Increase in the Scale for measuring resilience with Mexicans (RESI-M)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
Other outcomes:
Locations:
city: Juarez
country: Mexico
facility: Universidad Autónoma de Ciudad Juárez
state: Chihuahua
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
state: Jalisco
city: Mexico
country: Mexico
facility: Universidad Nacional Autónoma de México
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Anabel de la Rosa Gómez, PhD
role: STUDY_CHAIR
affiliation: Universidad Internacional del Ecuador
name: Paulina Erika Herdoiza Arroyo, PhD
role: STUDY_CHAIR
affiliation: Universidad Autonoma de Ciudad Juarez
name: Rosa Olimpia Castellanos Vargas, MD
role: STUDY_CHAIR
affiliation: Valencian International University
name: Joaquín Mateu Molla, PhD
role: STUDY_CHAIR
affiliation: University of Buenos Aires
name: Luis Farfallini, PhD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Eduardo Bautista Valerio, BD
role: STUDY_CHAIR
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