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

Study Overview
=================
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: Post-traumatic diagnostic scale Plutchik Suicide Risk Scale Generalized Anxiety Scale. The Center for Epidemiological Studies Depression Scale-Revised Professional Quality of Life Measure Pittsburgh Sleep Quality Index Scale for measuring resilience with Mexicans Appraisal of Self-care Agency The Fear of COVID-19 Scale Opinion on the treatment. System usability scale

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

Conditions
-----------------
Anxiety, Depression, Sleep Disturbance, Quality of Life, Burnout, Professional, Stress, Fatigue, Compassion

Intervention / Treatment
-----------------
* Behavioral: Online psychological intervention for healthcare workers


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Self-applied psychological intervention for healthcare workers<br>Participants in this group will receive 9 sessions of a multi-component psychological intervention focused on the reduction of symptoms of anxiety, depression, stress, burnout, fatigue compassion, and post-traumatic stress, and the increase of the quality of sleep and perception of the quality of life. The participants will have the option to do 3 extra modules that are complimentary for the intervention. | Behavioral: Online psychological intervention for healthcare workers<br>* The intervention is based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation Therapy, Acceptance and Commitment Therapy and Positive Psychology, aimed at the Psychoeducation regarding the manifestations of anxiety, depression, burnout, fatigue compassion, posttraumatic stress disorder, and affectations in sleep quality and perception of life quality in healthcare workers. And 3 complementary modules that according to the scientific literature could affect the mental health of healthcare workers related to how to deliver bad health news, Psychological first aid and how beliefs could influence physical and emotional self-care in the face of the COVID-19 pandemic.<br>|
| Active Comparator: Control: Self-applied psychological intervention for healthcare workers<br>The participants in this group will receive exactly the same intervention but delivered through a therapist in a weekly session through an online video call. The participants will be informed also about the 3 extra modules and briefly what it is the contents of these modules so they can accept or not receive these extra contents. | Behavioral: Online psychological intervention for healthcare workers<br>* The intervention is based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation Therapy, Acceptance and Commitment Therapy and Positive Psychology, aimed at the Psychoeducation regarding the manifestations of anxiety, depression, burnout, fatigue compassion, posttraumatic stress disorder, and affectations in sleep quality and perception of life quality in healthcare workers. And 3 complementary modules that according to the scientific literature could affect the mental health of healthcare workers related to how to deliver bad health news, Psychological first aid and how beliefs could influence physical and emotional self-care in the face of the COVID-19 pandemic.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) | The CESD-R is an updated version of the CES-D. The CESD-R consists of 20. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where ^16 is the cut-off point for this scale, and higher scores indicate more symptoms of depression. It is expected a statistically significant decrease (P < 0.05) in depression symptoms. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 
| Decrease in the symptoms of General Anxiety Disorder (GAD-7) | On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are not at all, several days, more than half the days, and nearly every day, scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. Is expected a statistically significant decrease (P < 0.05) in the General Anxiety symptoms. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 
| Decrease in the score of The Pittsburgh Sleep Quality Index (PSQI). | This instrument assesses the quality patterns of sleep. It differentiates the poor and good sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is 5 that indicates a poor sleep quality. It is expected a statistically significant decrease (P < 0.05) in the Sleep Quality measure. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 
| Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale (PSS) | The Post-Traumatic Stress Disorder Symptom Scale is a 17-item structured interview. The severity over the last 2 weeks of each item on the PSS is rated by the interviewer using a 4-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, and 3 = very much. The maximum possible score is 51 (severely affected) and the minimum possible score is 0 (total absence of the symptoms). The total severity score is calculated as the sum of the severity ratings for the 17 items. The diagnosis of the Post-Traumatic Stress Disorder Symptom Scale is made when at least 1 re-experiencing, 3 avoidance, and 2 arousal symptoms are endorsed on the scale by individuals who were traumatized at least one month prior to the assessment. It is expected a statistically significant decrease (P < 0.05) in the symptoms of Post-Traumatic Stress Disorder in the patients suffering from this disorder. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 
| Increase in the score of the Professional Quality of Life Measure (ProQOL) | The professional quality of life will be evaluated with the ProQOL scale (Professional Quality of Life Measure). This scale measures the sections of Satisfaction by empathy, compassion fatigue, and Burnout. The scale is composed of 30 Likert-type questions with five possible answers, being: Never = 1, Rarely = 2, Sometimes = 3, Often = 4 and Often = 5. A score of 17 could indicate affect action in the measured dimensions. It is expected a statistically significant decrease (P < 0.05) in the perception of Professional Quality of Life of the patients. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 
| Increase in the score of the Appraisal of Self-care Agency (ASA) | This scale is made up of 24 Likert-type reagents with four types of response, which have a score of one to four points, which when performing the final sum may result in the range of 24-96. The higher the resulting score, the greater the person's self-care capabilities. Maximum ability of self-care is reflected with a score of 96 and a minimum with 24, where high scores of self-care are with scores equal or higher to 76, for a medium ability with equal or higher to 70 but equal or lower than 75 and a low ability any score of 69 or lower. It is expected a statistically significant increase (P < 0.05) in the in the score of the Appraisal of Self-care Agency. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the Plutchik Suicide Risk Scale (BSI) | The Plutchik Suicide Risk Scale is a structured self-report questionnaire for evaluating Suicide Risk. It consists of 15 items that assess the history of suicide attempts, ideation, and suicide plans. It differentiates patients with a suicide risk from the non-suicide risk. This scale has dichotomous responses of Yes/No, and has a cut-off point of 6, where a point above the cut-off means a higher suicide risk. In this study, the suicidal patients are not considering the depression treatment although is necessary to assess depressive patients to refer to specialized treatment. | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. | 
| Increase in the Scale for measuring resilience with Mexicans (RESI-M) | The RESI-M scale is composed of 43 items, the responses are Likert type (totally disagree, disagree, agree, and totally agree). It is expected a statistically significant increase (P < 0.05) in the in the score of resilience | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules. |