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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patients are not aware that there is an experimental group and a control group, the participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Research Ethics Committee of the Universidad Autónoma de Ciudad Juárez.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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.
Increase in the score of the Appraisal of Self-care Agency (ASA)
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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.
Decrease in the score of The Pittsburgh Sleep Quality Index (PSQI).
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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.
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale (PSS)
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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.
Increase in the score of the Professional Quality of Life Measure (ProQOL)
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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.
Decrease in the symptoms of General Anxiety Disorder (GAD-7)
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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.
次要结局
- Decrease in the Plutchik Suicide Risk Scale (BSI)(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)(Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.)