This study aims to explore the implementation of a group psychological intervention to promote mental health and prevent and manage psychological distress in primary care workers with regard to the COVID-19 pandemic.
This general objective is broken down into the following specific objectives: (1) measure the clinical effects of the intervention in terms of resilience, psychological symptoms, burnout, and professional quality of life; (2) identify predictors of the clinical effects of the intervention; (3) explore, from a qualitative perspective, the experience and perceptions of the participants (including both the healthcare workers who receive the intervention and the psychologists who deliver it) regarding the feasibility, usefulness, effectiveness and integration of the skills learned into their work and personal lives, and identify facilitators, barriers and proposals to improve the program and its implementation; and lastly, (4) shape the psychoeducational program and the implementation strategy based on the results obtained from the evaluation of it.
This is a single-arm study of the implementation of a healthcare intervention with a pre and post-intervention design, using a mixed methods approach that combines both qualitative and quantitative data analysis . The design involves the implementation and evaluation of the intervention in real clinical practice.
Settings and participants
The scope of this project is the 332 primary care centers of the Catalan Institute of Health, which cover approximately 75% of the inhabitants of Catalonia (Spain) . The target population is the staff of these primary care centers, comprising all professional profiles of the primary care teams: primary care nurses, family doctors, pediatricians, dentists, physiotherapists, nutritionists, social workers and administrative staff . In Catalonia’s primary care system, administrative staff in the primary care centers, although they are non-clinical professionals are recognized as integral members of the Primary Care Team. They are responsible for tasks such as patient reception, guidance, and assistance. Furthermore, a study focusing on the emotional toll of the pandemic on primary care personnel identified administrative staff as a vulnerable group with a heightened risk of experiencing adverse mental health effects .
Having a severe mental disorder or being in the process of litigation for work disability due to a psychological disorder are exclusion criteria for the evaluation process.
The intervention consists of a group psychoeducational program aimed at primary care professionals developed at the initiative of the Directorate of Primary Care of the Catalan Institute of Health as part of the Program for Emotional Well-being and Community Health in Primary Care (Department of Health, Generalitat de Catalunya) . It was designed in collaboration with working groups formed by psychologists with expertise in the various areas included in the program. Based on a selection of psychological and psychoeducational interventions backed by scientific evidence, a toolbox was created, or rather, a set of strategies that primary care professionals can integrate into their personal and professional lives to promote psychological well-being and prevent adverse mental health. The program also aims to create safe spaces for emotional venting to reduce the emotional burden and to improve group cohesiveness and peer support.
The sessions will be delivered by the community psychologists linked to the primary care centers as part of the aforementioned Emotional Well-being Program. The psychoeducational program will be offered at all the primary care centers of the Catalan Institute of Health and will be open for participation to the personnel of these centers. It consists of 11 in-person weekly or biweekly sessions lasting 45 to 60 min, which will be held at the primary care centers during the professionals’ work hours. The content of the sessions is structured as follows: a brief introduction to the theory behind the concept to be discussed, a practical part where activities related to the topic of the session are conducted and, lastly, a brief guided meditation. Table 1 presents the session topics and contents. Although the structure and specific contents of each session are defined in the protocol, it is expected that the program may be modified or adapted based on local preferences, conditions, and needs (e.g., the number and/or order of sessions, frequency or structure of the sessions, or the addition of new topics). In a subsequent phase, it is anticipated that these group sessions will be incorporated into the regular routine of primary care centers, providing professionals with the opportunity to focus on their emotional well-being through a proactive approach to preventing and promoting mental health, which will be sustained beyond the scope of this project.
Intervention: implementation strategy
We have developed an implementation strategy based on the PARIHS model (Promoting Action on Research Implementation in Health Services) . According to this theoretical and operational framework, successful implementation is dependent on three factors: evidence that supports the proposed program, the context in which the new program is to be applied, and the facilitation factors that drive and maintain it.
The PARIHS framework recognizes evidence that supports implementation in a broad sense, including both explicit sources of evidence (i.e., published research) and implicit evidence from other sources such as the experience and knowledge of the psychologists conducting the psychoeducational program. The opinions and preferences of the healthcare workers receiving the intervention are also included as sources of evidence. There is evidence on the effectiveness of interventions to promote resilience and psychological well-being in health workers, which will be reviewed and evaluated [21, 22]. Implicit knowledge will be gathered through qualitative techniques, such as individual and group interviews with leading professionals in the fields of primary care, mental health, and occupational health.
The context, includes the characteristics of the healthcare organization (i.e., receptivity, culture of innovation, leadership, available resources) that promote implementation and the barriers that the implementation team should investigate, identify, and manage. One aspect of our context that contributes to the likelihood of successful implementation of the program is the institutional commitment of the Primary Care Division of the Catalan Institute of Health to it as a priority project.
Facilitation refers to the support provided to achieve the effective implementation of the psychoeducational program. The management positions of the health institution involved in the deployment of the program, as well as the local and regional managers of the network of community psychologists will be appointed internal facilitators (i.e., from within the health organization). Strategies will be developed to foster a sense of belonging, involvement and commitment to the project among this network of community psychologists. External facilitation will be conducted by the core implementation team (linked to the research team promoting this project). They will carry out the tasks of training, technical support, advice, evaluation, feedback, adaptation of the intervention to the local context, accreditation, and inter-institutional coordination, among others.
We will evaluate a set of quantitative indicators covering various aspects of the care process:
Number of editions of the program held during the study period.
Number of primary care centers where at least one edition of the program was held over the total number of primary care centers.
Number of editions during which at least 6 of the 11 standard program sessions were held.
Number of healthcare professionals who participated in the program over the target population, both in total and by professional profile.
Percentage of participants who attended at least 6 sessions, in total and by professional profile.
The outcomes will be prospectively assessed individually, with designated assessment points established at the baseline, i.e., before starting the psychoeducational intervention, immediately following the intervention, at 3 months and 6 months after the intervention (Table 2). Data will be collected through standardized online questionnaires that participants will complete independently.
Outcomes: baseline measurements and prospective follow-up
Professional quality of life in the psychological area: This will be measured with the ProQOL [23, 24], a questionnaire with 30 items that explore the feelings and perceptions of health professionals regarding their work and which are answered on a Likert scale for frequency, from 1 (“never”) to 5 points (“always”). The following dimensions are evaluated: compassion satisfaction, which measures the satisfaction derived from being able to do work well and care for patients well; burnout, associated with feelings of hopelessness, exhaustion and difficulty meeting the demands of the job; and secondary traumatic stress, which is related to secondary exposure to stressful events in the workplace. The ProQOL shows psychometric goodness in its Spanish version, and Cronbach’s alphas in Spanish healthcare workers were reported to be 0.87 for compassion satisfaction, 0.70 for burnout, and 0.84 for secondary traumatic stress. [24, 25].
Psychological state: This will be measured with the Depression, Anxiety and Stress Scales (DASS-21) [26, 27]. The DASS-21 contains three scales that assess the presence of symptoms and indicators of depression, anxiety and stress. Each scale contains 7 items that are rated on a Likert scale from 0 points (“did not apply to me at all”) to 3 points (“applied to me very much or most of the time”). Psychometric features of the Spanish version of DASS-21 are comparable to those of the original English version. Data on internal consistency are good with high subscale coefficient alphas (0.93 for depression, 0.86 for anxiety, and 0.91 for stress) .
Resilience: Resilience is a process in which an individual develops adaptive skills in the face of adverse situations. This construct will be measured with the Connor-Davidson Resilience Scale (CD-RISC 10) [28, 29], which has 10 items with statements about behaviors and attitudes that are considered to denote resilience in the respondent. They are scored on a Likert scale from 0 points (“Not true at all.”) to 4 points (“True nearly all the time.”), such that higher scores indicate greater resilience. The Spanish version of the CD-RISC 10 has shown to provide valid and reliable data with a good internal consistency when used in a sample of workers (Cronbach’s alpha = 0.87) .
Secondary outcomes: prospective follow-up using self-reported forms
Compliance with program sessions (i.e., the number of sessions attended by the participant.).
Satisfaction with and personal evaluations of the program, answered by means of an ad hoc questionnaire with five-point Likert responses ranging from “completely disagree” to “completely agree”, including items on participants’ perceptions of the suitability of the objectives, content, and methodology of the program, and on the quality of the psychologist who delivers it.
Usefulness and practicability of the skills learned in their personal and professional lives, measured by means of an ad hoc questionnaire with five-point Likert responses, ranging from “completely disagree” to “completely agree”.
Explanatory variables: baseline measurements.
Sociodemographic and work characteristics: age, sex, marital status, profession, employment status, seniority in the workplace, health center where employed.
Self-assessment of general state of health, using the first item on the SF-12 survey , which classifies general health into five categories: excellent, very good, good, fair and poor.
Past and current mental disorders, and current psychopharmacological and/or psychotherapeutic treatment.
Contact with COVID-19 patients due to work (never, occasionally, frequently, continuously).
History of COVID-19 infection, severity and time elapsed since infection.
History of persistent COVID-19 symptoms, defined as symptoms lasting more than three months.
An initial analysis will be performed using standard statistical methods to describe the characteristics of the sample, specifically the prevalence and characteristics of the various emotional and psychological symptoms studied, as well as the factors associated with them.
Regarding the prospective follow-up of the cohort, an analysis will be conducted of the evolution of the variables related to participation in the psychoeducational activity. These analyses will include the evolution of the various emotional symptoms studied and the identification of predictive factors. Bivariate and multivariate analyses will be performed using logistic or linear regression models depending on the evaluated outcome to identify predictive factors of the evolution of the psychological variables. The level of significance will be set at p < 0.05 and ORs or mean differences will be reported as appropriate, as well as corresponding p values and 95% confidence intervals.
A theoretical study with a phenomenological approach will be conducted to understand participants’ perceptions and evaluations of their experience of the psychoeducational intervention. Participants in the qualitative study will be recruited from among (a) the psychologists conducting the new intervention, and from among (b) the professionals participating in the psychoeducational activity. Each profile will be analyzed independently.
The sampling will be theoretical, based on individuals who have expressed their willingness to participate in the qualitative study. They will be selected based on certain criteria to achieve maximum variety of discourse: (a) psychologists: geographic scope, size and rural or urban status of the primary care center, and degree of adherence to the standard psychoeducational program, and (b) health workers: sex, profession, seniority, geographic scope, level of impact to emotional state, and degree of adherence to the program activities.
The data will be collected through group and individual interviews conducted online. Group interviews will last 90 min, be moderated by a qualified researcher and have an observer. Individual interviews will be conducted with the participants who present the greatest emotional impact. Both individual and group interviews will preferably be conducted online using Microsoft Teams.
The topic script will include concepts such as the usefulness, feasibility and possibility of integrating the tools and strategies learned in the psychoeducational intervention into one’s personal and professional life. Obstacles and difficulties will be explored as well as any suggestions and proposals for improvement that might help us mold and perfect the intervention. The content of the sessions will be video and audio recorded and will later be transcribed literally and in full for analysis.
We will use thematic framework analysis to classify and organize the data according to key topics, concepts and predefined constructs. These will be analyzed using qualitative methods adapted from normalization process theory to identify barriers and facilitators in the different areas, delving into “hot spots” such as controversial issues and uncertainties.
A minimum of two group interviews with health workers and two with psychologists will be held, although as many as needed will be conducted until data saturation is reached.
Trial status and schedule
This study was registered with ClinicalTrials.gov with the identifier: NCT05720429 on February 9, 2023. Implementation of the psychoeducational program will run from September 2022 to December 2023; the primary completion date (i.e., date on which the last participant in the clinical study will be examined) will be June 2024; the qualitative analysis will be performed from April 2023 to May 2024; the analysis and publication of the results will take place from June 2024 to December 2024; the modeling and improvement of the psychoeducational program based on the results of the evaluations will occur between June 2024 and December 2024.
In accordance with the project schedule, the research team has already designed the psychoeducational program, edited and published the intervention manual and didactic materials. The authors are doing dissemination and information about the program, and a training course for psychologists to facilitate homogeneous deployment is currently being finalized. Some centers have started their first psychoeducational groups.
The study was designed in accordance with the Guide to Good Practice in Health Science Research  and the principles of the Declaration of Helsinki of the World Medical Association, modified in 2013 and the applicable regulations. The protocol was approved by the Jordi Gol IDIAP Ethics Committee (Barcelona, 27/05/2022; code 22/086-PCV).
This study explores the usefulness of an intervention performed in real practice, with voluntary recruitment and participation in a psychoeducational activity. Participants will be informed of the objectives and general aspects of this study and informed consent to participate will be obtained from all the participants. The informed consent will specifically include voluntariness, data security and confidentiality and their exclusive use for research purposes. It will also include non-maleficence for participants and the possibility of participating in the psychoeducational intervention without taking part in the evaluation. If, while participating in the program or study evaluation, significant situations of mental distress arise, circuits have been established to appropriately assess and approach them in the corresponding health facility.