A Psychoeducational Intervention to Prevent the Psychological Impact of COVID-19 Pandemic in Primary Care Workers
NCT ID: NCT05720429
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2500 participants
INTERVENTIONAL
2022-04-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants in group psychoeducational programs organized by community psychologists in their centers.
Exclusion Criteria
* Being in a litigation process due to inability to work due to a psychological disorder.
ALL
Yes
Sponsors
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Fundació Galatea
UNKNOWN
Institut Català de la Salut
OTHER
Department of Health, Generalitat de Catalunya
OTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Enric Aragonès
Senior Investigator
Principal Investigators
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Enric Aragonès Benaiges, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IDIAPJgol
Josep Basora Gallisà, MD, PhD
Role: STUDY_CHAIR
IDIAPJgol
Francisco M Martín Luján, MD, PhD
Role: STUDY_CHAIR
IDIAPJgol
Anna Berenguera Ossó, DrPH
Role: STUDY_CHAIR
IDIAPJgol
Ariadna Mas Casals, MD
Role: STUDY_CHAIR
Institut Català de la Salut
Sara Rodoreda Noguerola, MD
Role: STUDY_CHAIR
Institut Català de la Salut
Antoni Calvo López
Role: STUDY_CHAIR
Fundació Galatea, Fundació Privada
Concepción Rambla Vidal, MD
Role: STUDY_CHAIR
IDIAPJgol
Meritxell Guitart Peces
Role: STUDY_CHAIR
ICS
Eva García Cots
Role: STUDY_CHAIR
ICS
Locations
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Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Garcia-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.
Barba R. [Healthcare management during COVID-19 pandemia.]. Arch Esp Urol. 2020 Jun;73(5):330-335. Spanish.
Alonso 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.
Martinez-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.
Aragones 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.
Maunder 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.
Pollock 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.
Jimenez-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.
Galiana 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.
Stetler 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.
Lovibond 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.
Novy 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.
Ware 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.
Eldridge 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.
Aragones E, Rodoreda S, Guitart M, Garcia E, Berenguera A, Martin F, Rambla C, Aragones G, Calvo A, Mas A, Basora J. Study protocol: assessment of the usefulness and practicability of a psychoeducational intervention to prevent the negative psychological impact of the COVID-19 pandemic on primary care health workers. BMC Prim Care. 2023 Nov 4;24(1):231. doi: 10.1186/s12875-023-02187-2.
Related Links
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Intervention Manual
Online course for training implementers. user: ventilacioemocional password: convidat123
Online course videos
Procedure for RBEC implementers
Other Identifiers
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4R22/033
Identifier Type: OTHER
Identifier Source: secondary_id
SLT021/21/000028
Identifier Type: -
Identifier Source: org_study_id
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