Clinical trial NCT05720429: A Psychoeducational Intervention to Prevent the Psychological Impact of COVID-19 Pandemic in Primary Care Workers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Burnout, Professional
Keywords: mental health
health personnel
primary health care
COVID-19 pandemic
psychological support
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Fundació Galatea
name: Institut Català de la Salut
name: Department of Health, Generalitat de Catalunya
First posted: 2023-02-09
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental pragmatic study in a real clinical practice environment with a design before after with mixed quantitative-qualitative methodology. The intervention will be carried out in a decentralized way through the primary care centres of the Catalan Health Institute (over 250). All of the groups are supposed to receive the same intervention, although the diverse range of experiences will be described and measured as part of the program's implementation feasibility evaluation.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Design: Quasi-experimental pragmatic study in a real clinical practice environment with a design before-after with mixed quantitative-qualitative methodology.

Intervention: A psychoeducational program aimed at all professional roles of primary care workers, designed by an expert group and implemented by the community psychologists from the Primary Care Emotional Well-Being Program. It consists of eleven sessions about different tools and skills to promote emotional well-being and improve the ability to deal with stressful situations, developed with an eminently practical approach.

The strategy for the implementation and deployment of the intervention includes facilitators such as an intervention manual and an online training course for the psychologists who will apply it.

Measurements:

1. On the procedure of implementation: a set of quantitatively measurable indicators that cover different aspects of quality and performance of the implementation process (number of editions of the intervention, number of participants, adherence of participants, etc.).
2. On the clinical effect on participants: through standardized questionnaires that participants must fill out autonomously. A prospective evaluation of the main outcome variables (quality of working life, burnout, psychological state) will be carried out with basal evaluation points, before starting the intervention, at the end of the intervention, at 3 and 6 months.

Sub-study of qualitative methodology. Design: Study with a phenomenological approach to know the perceptions and assessments of the participants regarding the applied psychoeducational intervention. Collection of information: individual in-depth interviews and online group interviews, aimed at (a) health workers participating in psychoeducational groups, and (b) community psychologists who apply the intervention.

Scope. This experience will be carried out in the primary care centers of the Catalan Health Institute. Over 18 months, editions of psychoeducational activity will be carried out in a decentralized way.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: ProQOL Health Care Workers version
timeFrame: Change from baseline (before the intervention) to immediately after the intervention
measure: ProQOL Health Care Workers version
timeFrame: Change from baseline (before the intervention) to 3 months following the intervention
measure: ProQOL Health Care Workers version
timeFrame: Change from baseline (before the intervention) to 6 months following the intervention
measure: CD-RISC10
timeFrame: Change from baseline (before the intervention) to immediately after the intervention
measure: CD-RISC10
timeFrame: Change from baseline (before the intervention) to 3 months following the intervention
measure: CD-RISC10
timeFrame: Change from baseline (before the intervention) to 6 months following the intervention
measure: DASS-21
timeFrame: Change from baseline (before the intervention) to immediately after the intervention
measure: DASS-21
timeFrame: Change from baseline (before the intervention) to 3 months following the intervention
measure: DASS-21
timeFrame: Change from baseline (before the intervention) to 6 months following the intervention
Secondary outcomes:
Other outcomes:
measure: Qualitative research: facilitators
timeFrame: Up to six months after the intervention completion
measure: Qualitative research: barriers
timeFrame: Up to six months after the intervention completion
measure: Qualitative research: proposals for improvement
timeFrame: Up to six months after the intervention completion
Locations:
city: Barcelona
country: Spain
facility: Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
Study officials:
affiliation: IDIAPJgol
name: Enric Aragonès Benaiges, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IDIAPJgol
name: Josep Basora Gallisà, MD, PhD
role: STUDY_CHAIR
affiliation: IDIAPJgol
name: Francisco M Martín Luján, MD, PhD
role: STUDY_CHAIR
affiliation: IDIAPJgol
name: Anna Berenguera Ossó, DrPH
role: STUDY_CHAIR
affiliation: Institut Català de la Salut
name: Ariadna Mas Casals, MD
role: STUDY_CHAIR
affiliation: Institut Català de la Salut
name: Sara Rodoreda Noguerola, MD
role: STUDY_CHAIR
affiliation: Fundació Galatea, Fundació Privada
name: Antoni Calvo López
role: STUDY_CHAIR
affiliation: IDIAPJgol
name: Concepción Rambla Vidal, MD
role: STUDY_CHAIR
affiliation: ICS
name: Meritxell Guitart Peces
role: STUDY_CHAIR
affiliation: ICS
name: Eva García Cots
role: STUDY_CHAIR
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