跳至主要内容
临床试验/NCT05720429
NCT05720429招募中不适用

Evaluation of the Usefulness and Feasibility of a Psychoeducational Intervention to Prevent the Negative Psychological Impact of the COVID-19 Pandemic on Primary Health Care Professionals

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
2
主要终点
DASS-21

研究概览

简要总结

The goal of this quasi-experimental pragmatic study is to design, implement and evaluate a psychoeducational group intervention aimed at preventing the negative consequences of the COVID-19 pandemic on the psychological wellbeing and mental health of primary care healthcare workers.

The experience will be carried out in real clinical practice conditions and our purpose is to evaluate it not only in terms of clinical effectiveness but, especially, the terms of feasibility, usefulness, and possibility of this intervention being integrated into the usual practice in primary care centers.

There will be two types of participation and a mixed quantitative-qualitative methodology. On one hand, the healthcare workers that will receive the intervention and participate in the study by responding to various before and after online surveys with standardized scales. On the other hand, the community psychologists in charge of implementing the intervention, having received guidelines and training, will help gather the participants' data and will provide their perceptions, assessments, and opinions on the program through other questionnaires. After the intervention, a selection of both healthcare workers and psychologists will participate in qualitative in-depth, or group interviews to explore the nuances of their perceptions of the program.

The results will allow the investigators to know the usefulness and effectiveness of the intervention and, above all, to model and improve its design and implementation strategy, and promote its generalization beyond the framework of this project.

详细描述

The COVID-19 pandemic has constituted an extraordinarily stressful situation for healthcare professionals and has generated an impact in the form of psychological distress and the appearance of various mental health disorders. In this context, it is necessary to provide these professionals with strategies and skills to be able to manage stressful situations and prevent or minimize their negative impact.

The investigators hypothesize that the implementation of a psychoeducational group intervention framed in the Primary Care Emotional Well-Being Program (Department of Health) may be feasible, useful, and effective to prevent harmful psychological effects and increase the emotional well-being of healthcare professionals in the context of the pandemic.

General objective: To analyze the implementation of a psychological group intervention for the promotion/prevention of mental health and the improvement of the psychological distress of primary care professionals in relation to the COVID-19 pandemic.

Specific objectives:

  • Measure the clinical effects of the intervention in terms of psychological symptoms, burnout, and health-related quality of life.
  • Identify predictor factors concerning the clinical effects of the intervention
  • Identify different profiles of professionals based on their clinical response
  • To explore from a qualitative perspective the perceptions and assessments of the healthcare professionals who receive it and the community psychologists who apply it regarding barriers, facilitators, and proposals for improving the program and the implementation strategy.
  • Modeling/perfecting/individualizing the intervention

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Workers of Primary Care Healthcare Centers, from the Catalan Health Institute and other functionally dependent centers. Any professional profile.
  • Participants in group psychoeducational programs organized by community psychologists in their centers.

排除标准

  • Being currently diagnosticated with a severe mental health disorder.
  • Being in a litigation process due to inability to work due to a psychological disorder.

结局指标

主要结局

DASS-21

时间窗: Change from baseline (before the intervention) to 6 months following the intervention

Depression Anxiety and Stress Scale, 21 items. The DASS-21 contains three scales that assess the presence of symptoms or indicators of depression, anxiety, and stress. Each scale has seven items that are rated on a Likert scale from 0 points ("never happens to me") to 3 points ("almost always or always happens to me").

ProQOL Health Care Workers version

时间窗: Change from baseline (before the intervention) to 6 months following the intervention

Professional Quality of Life Scale, Health Care Workers version. A questionnaire with 30 items that reflect health workers' feelings and perceptions concerning their work. The items are answered on a Likert scale according to frequency, from 1 ("never") to 5 points ("always"). The following dimensions are evaluated: (1) Compassion satisfaction, which measures the satisfaction of being able to work well; (2) Perceived support; (3) Burnout; (4) Secondary traumatic stress, related to secondary exposure to stressful events in work; and (5) Moral distress, which reflects the conflict of facing difficult choices or in contradiction with personal values. The dimensions of compassion satisfaction and perceived support are considered health worker strengths, and burnout, traumatic stress, and moral distress are vulnerabilities.

CD-RISC10

时间窗: Change from baseline (before the intervention) to 6 months following the intervention

10-item Connor-Davidson Resilience Scale. A unidimensional self-reported scale consisting of 10 items measuring resilience. Respondents rate items on a 5-point Likert scale (0-4).

次要结局

未报告次要终点

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enric Aragonès

Senior Investigator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

研究点 (2)

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