Mental Health IssueMestralNCT05720429
A Psychoeducational Intervention to Prevent the Psychological Impact of COVID-19 Pandemic in Primary Care Workers
A study testing Psychoeducational program in people with Mental Health Issue and Burnout, Professional, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Burnout, Professional
- What is being tested?
- Psychoeducational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,419 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Being currently diagnosticated with a severe mental health disorder.
- Being in a litigation process due to inability to work due to a psychological disorder.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
Barcelona, Barcelona, 08007
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Mental Health Issue, Burnout, Professional
- Being tested
- Psychoeducational program
- Keywords
- mental health, health personnel, primary health care, COVID-19 pandemic, psychological support
- Medical subject headings
- Burnout, Professional, Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational programOther
Also called Programa Ventilació Emocional, Emotional Ventilation 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.
| Study group | Role | What they receive |
|---|---|---|
| Primary care workers | Experimental | 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. Receives: Other: Psychoeducational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (before the intervention) to immediately after the intervention
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.
Measured: Change from baseline (before the intervention) to 3 months following the intervention
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.
Measured: Change from baseline (before the intervention) to 6 months following the intervention
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).
Measured: Change from baseline (before the intervention) to immediately after the intervention
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).
Measured: Change from baseline (before the intervention) to 3 months following the intervention
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).
Measured: Change from baseline (before the intervention) to 6 months following the intervention
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").
Measured: Change from baseline (before the intervention) to immediately after the intervention
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").
Measured: Change from baseline (before the intervention) to 3 months following the intervention
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").
Measured: Change from baseline (before the intervention) to 6 months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Sep 2022
- Primary completion28 Feb 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Galatea, Institut Català de la Salut
- Responsible party
- Principal investigator, Enric Aragonès, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Enric Aragonès Benaiges, MD, PhD, Principal investigator, IDIAPJgolJosep Basora Gallisà, MD, PhD, Study chair, IDIAPJgolFrancisco M Martín Luján, MD, PhD, Study chair, IDIAPJgolAnna Berenguera Ossó, DrPH, Study chair, IDIAPJgolAriadna Mas Casals, MD, Study chair, Institut Català de la SalutSara Rodoreda Noguerola, MD, Study chair, Institut Català de la SalutAntoni Calvo López, Study chair, Fundació Galatea, Fundació PrivadaConcepción Rambla Vidal, MD, Study chair, IDIAPJgol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720429
- Sponsor's protocol ID
- SLT021/21/000028
- Other IDs
- 4R22/033
- Acronym
- Mestral
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Llor C, Moragas A. [Coronavirus and primary care]. Aten Primaria. 2020 May;52(5):294-296. doi: 10.1016/j.aprim.2020.03.002. Epub 2020 Apr 6. No abstract available. Spanish.
PubMed 32284192Garcia-Alegria J, Gomez-Huelgas R. COVID-19 disease: the hospital of the future is already here. Rev Clin Esp (Barc). 2020 Oct;220(7):439-441. doi: 10.1016/j.rce.2020.05.010. Epub 2020 Jun 3. No abstract available.
PubMed 32560916Barba R. [Healthcare management during COVID-19 pandemia.]. Arch Esp Urol. 2020 Jun;73(5):330-335. Spanish.
PubMed 32538801Alonso J, Vilagut G, Mortier P, Ferrer M, Alayo I, Aragon-Pena A, Aragones E, Campos M, Cura-Gonzalez ID, Emparanza JI, Espuga M, Forjaz MJ, Gonzalez-Pinto A, Haro JM, Lopez-Fresnena N, Salazar ADM, Molina JD, Orti-Lucas RM, Parellada M, Pelayo-Teran JM, Perez-Zapata A, Pijoan JI, Plana N, Puig MT, Rius C, Rodriguez-Blazquez C, Sanz F, Serra C, Kessler RC, Bruffaerts R, Vieta E, Perez-Sola V; MINDCOVID Working group. Mental health impact of the first wave of COVID-19 pandemic on Spanish healthcare workers: A large cross-sectional survey. Rev Psiquiatr Salud Ment (Engl Ed). 2021 Apr-Jun;14(2):90-105. doi: 10.1016/j.rpsm.2020.12.001. Epub 2020 Dec 10.
PubMed 33309957Martinez-Lopez JA, Lazaro-Perez C, Gomez-Galan J, Fernandez-Martinez MDM. Psychological Impact of COVID-19 Emergency on Health Professionals: Burnout Incidence at the Most Critical Period in Spain. J Clin Med. 2020 Sep 20;9(9):3029. doi: 10.3390/jcm9093029.
PubMed 32962258Aragones E, Fernandez-San-Martin M, Rodriguez-Barragan M, Martin-Lujan F, Solanes M, Berenguera A, Siso A, Basora J. Gender differences in GPs' strategies for coping with the stress of the COVID-19 pandemic in Catalonia: A cross-sectional study. Eur J Gen Pract. 2023 Dec;29(2):2155135. doi: 10.1080/13814788.2022.2155135. Epub 2022 Dec 19.
PubMed 36533663Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.
PubMed 17326946Pollock A, Campbell P, Cheyne J, Cowie J, Davis B, McCallum J, McGill K, Elders A, Hagen S, McClurg D, Torrens C, Maxwell M. Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review. Cochrane Database Syst Rev. 2020 Nov 5;11(11):CD013779. doi: 10.1002/14651858.CD013779.
PubMed 33150970Jimenez-Gimenez M, Sanchez-Escribano A, Figuero-Oltra MM, Bonilla-Rodriguez J, Garcia-Sanchez B, Rojo-Tejero N, Sanchez-Gonzalez MA, Munoz-Lorenzo L. Taking Care of Those Who Care: Attending Psychological Needs of Health Workers in a Hospital in Madrid (Spain) During the COVID-19 Pandemic. Curr Psychiatry Rep. 2021 Jun 19;23(7):44. doi: 10.1007/s11920-021-01253-9.
PubMed 34152465Galiana L, Arena F, Oliver A, Sanso N, Benito E. Compassion Satisfaction, Compassion Fatigue, and Burnout in Spain and Brazil: ProQOL Validation and Cross-cultural Diagnosis. J Pain Symptom Manage. 2017 Mar;53(3):598-604. doi: 10.1016/j.jpainsymman.2016.09.014. Epub 2017 Jan 3.
PubMed 28062348Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99.
PubMed 21878092Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Novy DM, Stanley MA, Averill P, Daza P. Psychometric comparability of English- and Spanish-language measures of anxiety and related affective symptoms. Psychol Assess. 2001 Sep;13(3):347-55. doi: 10.1037//1040-3590.13.3.347.
PubMed 11556271Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
PubMed 26978655
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05720429
- Acronym / sponsor ID
- Mestral / SLT021/21/000028
- Conditions
- Mental Health Issue, Burnout, Professional
- Keywords
- mental health, health personnel, primary health care, COVID-19 pandemic, psychological support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,419 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Fundació Galatea, Institut Català de la Salut
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Primary care workers | Experimental | Other: Psychoeducational programPrimary 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Being currently diagnosticated with a severe mental health disorder.
- Being in a litigation process due to inability to work due to a psychological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational programAlso: Programa Ventilació Emocional, Emotional Ventilation ProgramA 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 | Primary care workers |
Primary outcome
ProQOL Health Care Workers version
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 32284192Llor C, Moragas A. [Coronavirus and primary care]. Aten Primaria. 2020 May;52(5):294-296. doi: 10.1016/j.aprim.2020.03.002. Epub 2020 Apr 6. No abstract available. Spanish.
- Background: PubMed 32560916Garcia-Alegria J, Gomez-Huelgas R. COVID-19 disease: the hospital of the future is already here. Rev Clin Esp (Barc). 2020 Oct;220(7):439-441. doi: 10.1016/j.rce.2020.05.010. Epub 2020 Jun 3. No abstract available.
- Background: PubMed 32538801Barba R. [Healthcare management during COVID-19 pandemia.]. Arch Esp Urol. 2020 Jun;73(5):330-335. Spanish.
- Background: PubMed 33309957Alonso J, Vilagut G, Mortier P, Ferrer M, Alayo I, Aragon-Pena A, Aragones E, Campos M, Cura-Gonzalez ID, Emparanza JI, Espuga M, Forjaz MJ, Gonzalez-Pinto A, Haro JM, Lopez-Fresnena N, Salazar ADM, Molina JD, Orti-Lucas RM, Parellada M, Pelayo-Teran JM, Perez-Zapata A, Pijoan JI, Plana N, Puig MT, Rius C, Rodriguez-Blazquez C, Sanz F, Serra C, Kessler RC, Bruffaerts R, Vieta E, Perez-Sola V; MINDCOVID Working group. Mental health impact of the first wave of COVID-19 pandemic on Spanish healthcare workers: A large cross-sectional survey. Rev Psiquiatr Salud Ment (Engl Ed). 2021 Apr-Jun;14(2):90-105. doi: 10.1016/j.rpsm.2020.12.001. Epub 2020 Dec 10.
- Background: PubMed 32962258Martinez-Lopez JA, Lazaro-Perez C, Gomez-Galan J, Fernandez-Martinez MDM. Psychological Impact of COVID-19 Emergency on Health Professionals: Burnout Incidence at the Most Critical Period in Spain. J Clin Med. 2020 Sep 20;9(9):3029. doi: 10.3390/jcm9093029.
- Background: PubMed 36533663Aragones E, Fernandez-San-Martin M, Rodriguez-Barragan M, Martin-Lujan F, Solanes M, Berenguera A, Siso A, Basora J. Gender differences in GPs' strategies for coping with the stress of the COVID-19 pandemic in Catalonia: A cross-sectional study. Eur J Gen Pract. 2023 Dec;29(2):2155135. doi: 10.1080/13814788.2022.2155135. Epub 2022 Dec 19.
- Background: PubMed 17326946Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.
- Background: PubMed 33150970Pollock A, Campbell P, Cheyne J, Cowie J, Davis B, McCallum J, McGill K, Elders A, Hagen S, McClurg D, Torrens C, Maxwell M. Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review. Cochrane Database Syst Rev. 2020 Nov 5;11(11):CD013779. doi: 10.1002/14651858.CD013779.
- Background: PubMed 34152465Jimenez-Gimenez M, Sanchez-Escribano A, Figuero-Oltra MM, Bonilla-Rodriguez J, Garcia-Sanchez B, Rojo-Tejero N, Sanchez-Gonzalez MA, Munoz-Lorenzo L. Taking Care of Those Who Care: Attending Psychological Needs of Health Workers in a Hospital in Madrid (Spain) During the COVID-19 Pandemic. Curr Psychiatry Rep. 2021 Jun 19;23(7):44. doi: 10.1007/s11920-021-01253-9.
- Background: PubMed 28062348Galiana L, Arena F, Oliver A, Sanso N, Benito E. Compassion Satisfaction, Compassion Fatigue, and Burnout in Spain and Brazil: ProQOL Validation and Cross-cultural Diagnosis. J Pain Symptom Manage. 2017 Mar;53(3):598-604. doi: 10.1016/j.jpainsymman.2016.09.014. Epub 2017 Jan 3.
- Background: PubMed 21878092Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Intervention ManualLink provided by the sponsor.
- Online course for training implementers. user: ventilacioemocional password: convidat123Link provided by the sponsor.
- Online course videosLink provided by the sponsor.
- Procedure for RBEC implementersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enric Aragonès Benaiges, MD, PhD principal investigator
IDIAPJgol
Josep Basora Gallisà, MD, PhD study chair
IDIAPJgol
Francisco M Martín Luján, MD, PhD study chair
IDIAPJgol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational program in people with Mental Health Issue and Burnout, Professional, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ProQOL Health Care Workers version (time frame: Change from baseline (before the intervention) to immediately after the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720429, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.