A Psychoeducational Intervention to Prevent the Psychological Impact of COVID-19 Pandemic in Primary Care Workers

Sponsor

Jordi Gol i Gurina Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT05720429

Collaborator

Fundació Galatea (Other), Institut Català de la Salut (Other), Department of Health, Generalitat de Catalunya (Other)

2,500

Enrollment

Location

Arm

Anticipated Duration (Months)

75.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Issue Burnout, Professional	Other: Psychoeducational program	N/A

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:

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.).
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary care workers Primary care health personnel who will voluntarily join the psychoeducational program of their center. All professional profiles working in primary care centers are eligible (ie primary care nurses, physiotherapists, family doctors, pediatricians, dentists, administrative staff, etc.). Groups of 10-15 people. Several groups can be established in the same center if the demand is high enough.	Other: Psychoeducational program A psychoeducational program consisting of 11 one-hour sessions, with a weekly or biweekly frequency, each one regarding specific tools and skills to promote emotional well-being, self-care, and the ability to deal with stressful situations. They are conducted by community psychologists, who will give a brief theoretical introduction and then conduct practical group exercises that apply the concepts introduced. Every session ends with a relaxation exercise and some habits that the participants can incorporate into their daily life. Session Index: (1) Emotional management;(2) Thought management; (3) Stress management; (4) Communication skills, active listening, and empathy; (5) Self-care; (6) Individual/group self-esteem; (7) Anxiety/coping with panic. Mindfulness; (8) Activating motivation; (9) Problem-Solving; (10) Positive psychology and emotional intelligence; (11) Emotional expression through art. Other Names: Programa Ventilació Emocional

Arm

Intervention/Treatment

Experimental: Primary care workers

Primary care health personnel who will voluntarily join the psychoeducational program of their center. All professional profiles working in primary care centers are eligible (ie primary care nurses, physiotherapists, family doctors, pediatricians, dentists, administrative staff, etc.). Groups of 10-15 people. Several groups can be established in the same center if the demand is high enough.

Other: Psychoeducational program

A psychoeducational program consisting of 11 one-hour sessions, with a weekly or biweekly frequency, each one regarding specific tools and skills to promote emotional well-being, self-care, and the ability to deal with stressful situations. They are conducted by community psychologists, who will give a brief theoretical introduction and then conduct practical group exercises that apply the concepts introduced. Every session ends with a relaxation exercise and some habits that the participants can incorporate into their daily life. Session Index: (1) Emotional management;(2) Thought management; (3) Stress management; (4) Communication skills, active listening, and empathy; (5) Self-care; (6) Individual/group self-esteem; (7) Anxiety/coping with panic. Mindfulness; (8) Activating motivation; (9) Problem-Solving; (10) Positive psychology and emotional intelligence; (11) Emotional expression through art.

Other Names:

Programa Ventilació Emocional

Outcome Measures

Primary Outcome Measures

ProQOL Health Care Workers version [Change from baseline (before the intervention) to immediately after 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.
ProQOL Health Care Workers version [Change from baseline (before the intervention) to 3 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.
ProQOL Health Care Workers version [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 [Change from baseline (before the intervention) to immediately after 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).
CD-RISC10 [Change from baseline (before the intervention) to 3 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).
CD-RISC10 [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).
DASS-21 [Change from baseline (before the intervention) to immediately after 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").
DASS-21 [Change from baseline (before the intervention) to 3 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").
DASS-21 [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").

Other Outcome Measures

Qualitative research: facilitators [Up to six months after the intervention completion]
Facilitators of program implementation assessed using qualitative research methods
Qualitative research: barriers [Up to six months after the intervention completion]
Barriers of program implementation assessed using qualitative research methods
Qualitative research: proposals for improvement [Up to six months after the intervention completion]
Proposals for improvement of the psychoeducational program assessed using qualitative research methods

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.