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

Primary Purpose

Mental Health Issue, Burnout, Professional

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychoeducational program
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health Issue focused on measuring mental health, health personnel, primary health care, COVID-19 pandemic, psychological support

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi GolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary care workers

Arm Description

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.

Outcomes

Primary Outcome Measures

ProQOL Health Care Workers version
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
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
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
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
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
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
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
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
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").

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
February 8, 2023
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Fundació Galatea, Institut Català de la Salut, Department of Health, Generalitat de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05720429
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Fundació Galatea, Institut Català de la Salut, Department of Health, Generalitat de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Burnout, Professional
Keywords
mental health, health personnel, primary health care, COVID-19 pandemic, psychological support

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary care workers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Psychoeducational program
Other Intervention Name(s)
Programa Ventilació Emocional
Intervention Description
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.
Primary Outcome Measure Information:
Title
ProQOL Health Care Workers version
Description
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.
Time Frame
Change from baseline (before the intervention) to immediately after the intervention
Title
ProQOL Health Care Workers version
Description
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.
Time Frame
Change from baseline (before the intervention) to 3 months following the intervention
Title
ProQOL Health Care Workers version
Description
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.
Time Frame
Change from baseline (before the intervention) to 6 months following the intervention
Title
CD-RISC10
Description
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).
Time Frame
Change from baseline (before the intervention) to immediately after the intervention
Title
CD-RISC10
Description
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).
Time Frame
Change from baseline (before the intervention) to 3 months following the intervention
Title
CD-RISC10
Description
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).
Time Frame
Change from baseline (before the intervention) to 6 months following the intervention
Title
DASS-21
Description
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").
Time Frame
Change from baseline (before the intervention) to immediately after the intervention
Title
DASS-21
Description
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").
Time Frame
Change from baseline (before the intervention) to 3 months following the intervention
Title
DASS-21
Description
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").
Time Frame
Change from baseline (before the intervention) to 6 months following the intervention
Other Pre-specified Outcome Measures:
Title
Qualitative research: facilitators
Description
Facilitators of program implementation assessed using qualitative research methods
Time Frame
Up to six months after the intervention completion
Title
Qualitative research: barriers
Description
Barriers of program implementation assessed using qualitative research methods
Time Frame
Up to six months after the intervention completion
Title
Qualitative research: proposals for improvement
Description
Proposals for improvement of the psychoeducational program assessed using qualitative research methods
Time Frame
Up to six months after the intervention completion

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillem Aragonès Jové, PPE
Phone
+34934824124
Email
garagones@idiapjgol.info
First Name & Middle Initial & Last Name or Official Title & Degree
Enric Aragonès Benaiges, MD, PhD
Phone
+34977778518
Email
earagones.tgn.ics@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enric Aragonès Benaiges, MD, PhD
Organizational Affiliation
IDIAPJGol
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josep Basora Gallisà, MD, PhD
Organizational Affiliation
IDIAPJGol
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francisco M Martín Luján, MD, PhD
Organizational Affiliation
IDIAPJGol
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna Berenguera Ossó, DrPH
Organizational Affiliation
IDIAPJGol
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ariadna Mas Casals, MD
Organizational Affiliation
Institut Català de la Salut
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara Rodoreda Noguerola, MD
Organizational Affiliation
Institut Català de la Salut
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antoni Calvo López
Organizational Affiliation
Fundació Galatea, Fundació Privada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Concepción Rambla Vidal, MD
Organizational Affiliation
IDIAPJGol
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meritxell Guitart Peces
Organizational Affiliation
ICS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eva García Cots
Organizational Affiliation
ICS
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
City
Barcelona
ZIP/Postal Code
08007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillem Aragonès Jové
Phone
+34934824124
Email
ventilacioemocional@idiapjgol.info

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Links:
URL
http://www.projectemestral.cat
Description
(in construction)
URL
https://drive.google.com/file/d/1lz-9nC1AlN7AyW1c4jtA531fkRkQGHPt/view?usp=share_link
Description
Intervention Manual
URL
https://campus.idiapjgol.org/course/view.php?id=48
Description
Online course for training implementers. user: ventilacioemocional password: convidat123
URL
https://www.youtube.com/playlist?list=PLcUX3bp5a6GTacx-I7onAb3GKtDasJwZc
Description
Online course videos
URL
https://docs.google.com/document/d/1S1B5HMFK2Y87VCRJPHEC8_yQAT9qxYQ10G9uxJyl7d0/edit#heading=h.dkwk82s5y2zh
Description
Procedure for RBEC implementers

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

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