Online Multi-component Psychological Intervention for Healthcare Workers During COVID-19 Pandemic

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    42
  • sponsor
    Universidad Internacional de Valencia
Updated on 10 October 2021
depression
anxiety
behavior therapy
fatigue
behavioral therapy
depressed mood
Accepts healthy volunteers

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.

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

Details
Condition Depression (Major/Severe), Sleep Disorders (Pediatric), quality-of-life, Depressed, miserable, Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), depressive disorder, sleep disturbance, anxious, disturbed sleep, Burnout, Professional, Depression (Pediatric), trouble sleeping, sleep disorder, Sleep Disorders, Stress, problems with sleeping, Anxiety Disorders (Pediatric), Anxiety Symptoms, ANXIETY NEUROSIS, sleep dysfunction, sleep problem, Fatigue, Compassion, Depression (Treatment-Resistant), Quality of life, sleep disturbances, dyssomnia, depressive disorders, Endogenous depression, anxiety disorder, Depression (Adult and Geriatric), Anxiety Disorders, Depression, difficulty sleeping, Depression (Adolescent), depressed mood, Anxiety
Treatment Online psychological intervention for healthcare workers
Clinical Study IdentifierNCT04890665
SponsorUniversidad Internacional de Valencia
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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