Online Multi-component Psychological Intervention for Healthcare Workers During COVID-19 Pandemic
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
研究概览
地位
详细说明
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
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Alejandro Dominguez Rodriguez, PhD
- 电话号码:+521 664 471 3277
- 邮箱:alejandro.dominguez.r@campusviu.es
研究联系人备份
- 姓名:Reyna Jazmin Martinez Arriaga, PhD
- 电话号码:+52 1 33 1197 9082
- 邮箱:reyna.martinez@academicos.udg.mx
学习地点
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Mexico、墨西哥、54090
- 尚未招聘
- Universidad Nacional Autonoma de Mexico
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接触:
- Anabel De la Rosa Gómez, PhD
- 邮箱:anabel.delarosa@iztacala.unam.mx
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Chihuahua
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Juarez、Chihuahua、墨西哥、32315
- 招聘中
- Universidad Autonoma de Ciudad Juarez
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接触:
- Flor Rocío Ramírez Martínez, PhD
- 邮箱:rocio.ramirez@uacj.mx
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接触:
- Rosa Olimpia Castellanos Vargas, MD
- 电话号码:+52 1 33 1358 3137
- 邮箱:rosa.castellanos@uacj.mx
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Jalisco
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Guadalajara、Jalisco、墨西哥、44160
- 尚未招聘
- Universidad de Guadalajara
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接触:
- Reyna Jazmin Martínez Arriaga, PhD
- 邮箱:reyna.martinez@academicos.udg.mx
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Experimental: Self-applied psychological intervention for healthcare workers
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.
|
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. |
有源比较器:Control: Self-applied psychological intervention for healthcare workers
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.
|
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
大体时间: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.
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Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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Decrease in the symptoms of General Anxiety Disorder (GAD-7)
大体时间:Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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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.
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Decrease in the score of The Pittsburgh Sleep Quality Index (PSQI).
大体时间: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.
|
Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
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Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale (PSS)
大体时间: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.
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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)
大体时间: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.
|
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)
大体时间: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.
|
Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Decrease in the Plutchik Suicide Risk Scale (BSI)
大体时间:Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
|
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.
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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)
大体时间:Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
|
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
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Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.
|
合作者和调查者
合作者
调查人员
- 学习椅:Anabel de la Rosa Gómez, PhD、Universidad Nacional Autonoma de Mexico
- 学习椅:Paulina Erika Herdoiza Arroyo, PhD、Universidad Internacional del Ecuador
- 学习椅:Joaquín Mateu Molla, PhD、Valencian International University
- 学习椅:Eduardo Bautista Valerio, BD、Universidad Nacional Autonoma de Mexico
出版物和有用的链接
一般刊物
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- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
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- Koslowsky M, Bleich A, Greenspoon A, Wagner B, Apter A, Solomon Z. Assessing the validity of the Plutchik Suicide Risk Scale. J Psychiatr Res. 1991;25(4):155-8. doi: 10.1016/0022-3956(91)90019-7.
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- Williamson V, Stevelink SAM, Greenberg N. Occupational moral injury and mental health: systematic review and meta-analysis. Br J Psychiatry. 2018 Jun;212(6):339-346. doi: 10.1192/bjp.2018.55.
- Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Paul V, Patel S, Royse M, Odish M, Malhotra A, Koenig S. Proning in Non-Intubated (PINI) in Times of COVID-19: Case Series and a Review. J Intensive Care Med. 2020 Aug;35(8):818-824. doi: 10.1177/0885066620934801.
- Allan SM, Bealey R, Birch J, Cushing T, Parke S, Sergi G, Bloomfield M, Meiser-Stedman R. The prevalence of common and stress-related mental health disorders in healthcare workers based in pandemic-affected hospitals: a rapid systematic review and meta-analysis. Eur J Psychotraumatol. 2020 Oct 16;11(1):1810903. doi: 10.1080/20008198.2020.1810903.
- Pappa S, Ntella V, Giannakas T, Giannakoulis VG, Papoutsi E, Katsaounou P. Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19 pandemic: A systematic review and meta-analysis. Brain Behav Immun. 2020 Aug;88:901-907. doi: 10.1016/j.bbi.2020.05.026. Epub 2020 May 8. Erratum In: Brain Behav Immun. 2021 Feb;92:247.
- Luo M, Guo L, Yu M, Jiang W, Wang H. The psychological and mental impact of coronavirus disease 2019 (COVID-19) on medical staff and general public - A systematic review and meta-analysis. Psychiatry Res. 2020 Sep;291:113190. doi: 10.1016/j.psychres.2020.113190. Epub 2020 Jun 7.
- Smith GD, Ng F, Ho Cheung Li W. COVID-19: Emerging compassion, courage and resilience in the face of misinformation and adversity. J Clin Nurs. 2020 May;29(9-10):1425-1428. doi: 10.1111/jocn.15231. Epub 2020 Mar 10. No abstract available.
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- Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.
- Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- VIU-Health_care_workers_COVID
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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