Clinical Trials Logo

Clinical 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. 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.


Clinical Trial Description

The COVID-19 pandemic has constituted an extraordinarily stressful situation for healthcare professionals and has generated an impact in the form of psychological distress and the appearance of various mental health disorders. In this context, it is necessary to provide these professionals with strategies and skills to be able to manage stressful situations and prevent or minimize their negative impact. The investigators hypothesize that the implementation of a psychoeducational group intervention framed in the Primary Care Emotional Well-Being Program (Department of Health) may be feasible, useful, and effective to prevent harmful psychological effects and increase the emotional well-being of healthcare professionals in the context of the pandemic. General objective: To analyze the implementation of a psychological group intervention for the promotion/prevention of mental health and the improvement of the psychological distress of primary care professionals in relation to the COVID-19 pandemic. Specific objectives: - Measure the clinical effects of the intervention in terms of psychological symptoms, burnout, and health-related quality of life. - Identify predictor factors concerning the clinical effects of the intervention - Identify different profiles of professionals based on their clinical response - To explore from a qualitative perspective the perceptions and assessments of the healthcare professionals who receive it and the community psychologists who apply it regarding barriers, facilitators, and proposals for improving the program and the implementation strategy. - Modeling/perfecting/individualizing the intervention Design: Quasi-experimental pragmatic study in a real clinical practice environment with a design before-after with mixed quantitative-qualitative methodology. Intervention: A psychoeducational program aimed at all professional roles of primary care workers, designed by an expert group and implemented by the community psychologists from the Primary Care Emotional Well-Being Program. It consists of eleven sessions about different tools and skills to promote emotional well-being and improve the ability to deal with stressful situations, developed with an eminently practical approach. The strategy for the implementation and deployment of the intervention includes facilitators such as an intervention manual and an online training course for the psychologists who will apply it. Measurements: 1. On the procedure of implementation: a set of quantitatively measurable indicators that cover different aspects of quality and performance of the implementation process (number of editions of the intervention, number of participants, adherence of participants, etc.). 2. On the clinical effect on participants: through standardized questionnaires that participants must fill out autonomously. A prospective evaluation of the main outcome variables (quality of working life, burnout, psychological state) will be carried out with basal evaluation points, before starting the intervention, at the end of the intervention, at 3 and 6 months. Sub-study of qualitative methodology. Design: Study with a phenomenological approach to know the perceptions and assessments of the participants regarding the applied psychoeducational intervention. Collection of information: individual in-depth interviews and online group interviews, aimed at (a) health workers participating in psychoeducational groups, and (b) community psychologists who apply the intervention. Scope. This experience will be carried out in the primary care centers of the Catalan Health Institute. Over 18 months, editions of psychoeducational activity will be carried out in a decentralized way. The results will allow the investigators to know the usefulness and effectiveness of the intervention and, above all, to model and improve its design and implementation strategy, and promote its generalization beyond the framework of this project. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05720429
Study type Interventional
Source Jordi Gol i Gurina Foundation
Contact Guillem Aragonès Jové, PPE
Phone +34934824124
Email garagones@idiapjgol.info
Status Recruiting
Phase N/A
Start date April 1, 2022
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Not yet recruiting NCT05886595 - Being Young : My Mental Health
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Not yet recruiting NCT04030858 - The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery N/A
Recruiting NCT04926675 - Development of a Money Advice Intervention Within IAPT N/A
Recruiting NCT06105970 - Chinese Community Sample of Hierarchical Model of Psychopathology
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Completed NCT05056428 - Effects of Mindfulness Training on Emotional Care Strategies N/A
Not yet recruiting NCT04978194 - Effects of an Intervention on University Students' Mental Health and Learning During COVID-19 N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT06080685 - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Not yet recruiting NCT06266936 - Smart Life Smart Living Intercontinental - Medical Students' Cohort
Not yet recruiting NCT05979649 - An Internet-Based Intervention With Peer Support for the Mental Health of Youths N/A
Not yet recruiting NCT06006936 - Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women N/A
Recruiting NCT05492305 - Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A
Recruiting NCT05563285 - Effect of Exercise and MBI on Female Students' Emotion Regulation and Inhibitory Control of Smartphone Addiction N/A