Assessing a Multicomponent Intervention to Improve Quality of Life in Individuals With Long COVID-19 (COVIDL/MIQoL): A Randomized Controlled Trial
Phase: NA
Conditions: Long COVID-19
Sponsor: Consorci Sanitari de Terrassa

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Assessing a multicomponent 
intervention to improve quality of 
life in individuals with Long 
COVID (COVIDL/MIQoL): study 
protocol for a randomized 
controlled trial
Mireia Morera 1, Antonio Arévalo 1, Cristina Garriga 1, 
Marta Corral-Magaña 1, Mari Carmen García-Arqué 1, 
Marta Gragea-Nocete 1, Cristina Pérez Díaz 1, Ramon Roca 2 and 
Maria Llistosella 1*
1 Primary Health Care, Consorci Sanitari de Terrassa, Barcelona, Spain, 2 Fundació Joan Costa Roma, 
Consorci Sanitari de Terrassa, Barcelona, Spain
Introduction: The impact of Long COVID on the quality of life of affected 
individuals is significant, therefore, the aim of this study is to analyse the 
effectiveness of the multicomponent intervention protocol to improve quality 
of life in individuals with Long COVID.
Methods: A randomized controlled trial with two parallel arms will be conducted. 
Individuals diagnosed with Long COVID, but without any severe mental disorders, 
will be  recruited. The sample size is estimated to be  around 54 participants 
per group. A psychologist and a physiotherapist will carry out the intervention 
between January and March 2025. Participants will receive specific training 
in psycho-education and physical rehabilitation consisting of 18 sessions, to 
be held twice a week. Data collection will start in January 2025 and will finish in 
October 2025. Data will be collected: at baseline, before the intervention (T0); 
after 9 weeks, post-intervention (T1); and after 24 weeks, follow-up (T2), and 
will assess quality of live, well-being, anxiety, depression resilience, fatigue, and 
physical activity. An intention-to-treat analysis will be performed and the effect 
size will be calculated using Cohen’s d. All statistical analyses will be performed 
using R software version 4.2.2, with a 95% confidence level and a statistical 
significance level of p < 0.05.
Discussion/conclusion: The results will be  disseminated to individuals with 
Long COVID and their families throughout their primary health care center. 
Healthcare professionals will receive specific training to be able to develop and 
implement the intervention. In addition, the results will be disseminated to the 
scientific community via conferences and publications.
Clinical trial registration: https://register.clinicaltrials.gov/prs/beta/studies/
S000ENW100000080/recordSummary, Identifier NCT06492590.
KEYWORDS
Long COVID, randomized controlled trial, quality of life, multicomponent 
intervention, mental wellbeing
OPEN ACCESS
EDITED BY
César Fernández-de-las-Peñas, 
Rey Juan Carlos University, Spain
REVIEWED BY
Jesús González-Moreno, 
Valencian International University, Spain
Mustafa Oğuz Kethüdaoğlu, 
Cumhuriyet University, Türkiye
*CORRESPONDENCE
Maria Llistosella 
 mllistosella@cst.cat
RECEIVED 02 April 2025
ACCEPTED 30 April 2025
PUBLISHED 19 May 2025
CITATION
Morera M, Arévalo A, Garriga C, ​
Corral-Magaña M, ​García-Arqué MC, ​
Gragea-Nocete M, Pérez Díaz C, Roca R and 
Llistosella M (2025) Assessing a 
multicomponent intervention to improve 
quality of life in individuals with Long COVID 
(COVIDL/MIQoL): study protocol for a 
randomized controlled trial.
Front. Public Health 13:1604971.
doi: 10.3389/fpubh.2025.1604971
COPYRIGHT
© 2025 Morera, Arévalo, Garriga, 
Corral-Magaña, García-Arqué, 
Gragea-Nocete, Pérez Díaz, Roca and 
Llistosella. This is an open-access article 
distributed under the terms of the Creative 
Commons Attribution License (CC BY). The 
use, distribution or reproduction in other 
forums is permitted, provided the original 
author(s) and the copyright owner(s) are 
credited and that the original publication in 
this journal is cited, in accordance with 
accepted academic practice. No use, 
distribution or reproduction is permitted 
which does not comply with these terms.
TYPE  Study Protocol
PUBLISHED  19 May 2025
DOI  10.3389/fpubh.2025.1604971

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1 Introduction
Coronavirus disease 2019 (COVID-19), caused by the severe 
acute respiratory syndrome 2 coronavirus (SARS-COV-2), can have 
persistent symptoms (1) and significant long-term health effects. The 
persistence of symptoms after acute SARS-CoV-2 infection, known as 
persistent COVID (COVID-P) or Long COVID (2), has emerged as a 
wide-ranging public health challenge. This condition, characterized 
by a wide range of physical and psychological symptoms that persist 
for at least 12 weeks following acute COVID-19 infection, exhibits 
symptoms that are not attributable to causes other than SARS-CoV-2 
infection (3).
Many symptoms that could be classified as Long COVID have 
been described in the literature. The most common are: fatigue, fever, 
dry cough, dyspnoea, anosmia, ageusia, arthralgia, myalgia, diarrhea, 
headaches, cardiorespiratory problems, emotional disorders, mental 
fog, sleep disorders, cognitive disorders and mood disorders (3). A 
systematic review conducted by Nassarie et al. (1) identified more than 
80 symptoms, highlighting that the most frequently were: shortness of 
breath or dyspnoea, fatigue or exhaustion, and sleep disorders or 
insomnia (1). The prevalence of depression and anxiety was estimated 
in 20% of cases, 2 years after COVID-19 (4). Additionally, one of the 
most prevalent symptoms was cognitive impairment, which leads to 
a significant degree of disability and poor quality of life (5).
In individuals who have experienced COVID-19, 10–20% may 
have long-term symptoms (6). However, this percentage could change 
according to the specific definition of the condition (7), as well as the 
severity of acute COVID-19 disease, which ranged from 6 to 46% in 
non-hospitalized individuals (7, 8). Approximately 200 million people 
worldwide live with long-term symptoms of COVID-19, according to 
estimates by a systematic review involving meta-analysis that was 
conducted by Chen et al. (8). More recently, another meta-analysis 
reported a prevalence of 30%, two-years after COVID-19 (4).
The impact of Long COVID on the quality of life of affected 
individuals is significant (9). Their quality of life is reduced, as is their 
ability to work. Physically, patients may experience chronic fatigue, 
pain, breathing difficulties, and a wide variety of the symptoms listed 
above, and this may limit their ability to carry out daily activities 
(9, 10).
Several recommendations have been made for the therapeutic 
management of Long COVID in primary care, with multidisciplinary 
rehabilitation, comprising physical, psychological and psychiatric 
aspects, being the treatment of choice (11). More specifically, 
according to NICE guidelines (11), multidisciplinary rehabilitation 
could include: providing information and education, supportive self-
care, peer support, symptom management strategies and physical 
rehabilitation. Similarly, the Stanford Hall consensus proposes a 
multidisciplinary 
approach 
including: 
pulmonary/cardiac 
rehabilitation, exercise therapy, psychological management, 
musculoskeletal symptom management, neurorehabilitation, and 
medical counseling (12).
Given the multidimensional impact of Long COVID, a holistic 
approach to the disease and all its implications must be sought in 
order to improve the quality of life of affected individuals. To the best 
of our knowledge, in the primary care setting, there are few published 
clinical trials detailing the use of multicomponent interventions 
involving psycho-educational and physical rehabilitation activities to 
improve the quality of life of individuals with Long COVID. Among 
these, we can highlight the NUTESCOTI project: an intervention 
program including RVI that uses the MK Player 360 projector and 
includes mindfulness exercises, cognitive stimulation and physical 
rehabilitation (13); and an online physical and mental health 
rehabilitation program, called the REGAIN study (14). Positive 
outcomes, such as an increase in the quality of life of the participants 
(13) and improving cognition (14), were obtained from 
these projects.
Furthermore, the study conducted by Nikrah et  al. (15) 
examined the efficacy of acceptance and commitment therapy on 
resilience and health-related quality of life in patients with post-
acute COVID-19 syndrome. The results of this study showed a 
significant increase in resilience that was sustained at 3 
months (15).
The World Health Organization has now called for priority to 
be  given to the rehabilitation of the emotional, physical and 
cognitive consequences of COVID-19 (16). In this line, the 
present study aims to assess an innovative, multicomponent 
intervention, 
including 
psycho-education 
and 
physical 
rehabilitation, which is aligned with the complex needs of 
individuals with Long COVID.
2 Study objectives and hypotheses
2.1 Objectives
Assess the effectiveness of a multicomponent intervention in 
individuals with Long COVID.
Increase the quality of life, mental wellbeing, resilience, and 
physical condition in individuals with Long COVID.
Decrease the incidence of anxiety, depressed moods and fatigue 
in individuals with Long COVID.
2.2 Research hypothesis
We hypothesize that participants with Long COVID who receive 
the multicomponent intervention (psycho-education and physical 
rehabilitation) will experience an improvement in their quality of life, 
mental wellbeing, resilience, physical condition and cognitive 
functions, and a reduction in anxiety, depressed moods and fatigue, 
compared to the control group.
3 Methods and analysis
3.1 Design
This study will be a Randomized controlled trial with parallel 
arms. It will follow the recommendations of the Consolidated 
Standards of Reporting Trials (CONSORT) (17). The SPIRIT 
guidelines will also be followed (18). The trail has been registered in 
as Clinical trial NCT06492590.

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3.2 Study setting and data collection
Individuals already diagnosed with Long COVID will 
be contacted by health professionals from different hospitals and 
centers belonging to the Consorci Sanitari de Terrassa (CST). Their 
eligibility will be assessed by these professionals and the principal 
researcher (MLL) in line with the established inclusion criteria. Two 
researchers (MLL, MCG) will then contact the candidates by 
telephone to offer them the opportunity to participate in the trial 
and they will be sent an online fact sheet with details of the study. 
Those who agree to participate must then sign the informed 
consent. Participants who give informed consent will be randomized 
into intervention and control groups. Once randomized, those in 
the intervention group will be subdivided into 4 subgroups of 13–14 
participants. Each subgroup will receive the multicomponent 
intervention (psycho-education and physical rehabilitation).
Recruitment will take place between October and December 
2024. A psychologist and a physiotherapist will carry out the 
intervention between January and March 2025. These professionals 
involved in the intervention will be  trained during two training 
sessions about Long COVID and activities included in 
the intervention.
Data collection will start in January 2025 and end in September 
2025. Data will be collected via a digital platform, at the baseline (T0), 
9 weeks after the intervention (T1), and after 24 weeks of follow-up 
(T2) (see Figure  1). Participant data will be  obtained using self-
reported psychometric scales provided by the APP. Throughout the 
study, data will be stored on a secure server, in line with Spanish 
regulations. Recruitment of participants will be performed according 
to CONSORT guidelines for randomized clinical trials (see 
Figure 2) (17).
3.3 Sample size
The sample size has been estimated on the basis of the main 
quality of life variable and will be assessed using the EuroQol5D-5 L 
scale (19). Accepting an alpha risk of 0.05 and a statistical power 
greater than 0.8 in a bilateral contrast, 34 subjects in group 1 and 34 in 
group 2 are needed to detect a difference equal to or greater than 
0.15 units. It is assumed that the common standard deviation is 0.21 
(range between 0.20 and 0.25). A follow-up loss rate of 0.1 (10%) has 
been estimated. The GRANMO tool (20) was used to calculate the 
sample size.
3.4 Participants
3.4.1 Inclusion criteria
Eligibility of individuals with a diagnosis of Long COVID made 
according to the WHO interim guideline (21).
Over 18 years of age and under 75 years of age.
Signing the informed consent form.
FIGURE 1
COVID-L/MIQoLI intervention: template enrolment, intervention, and assessments. WEMWBS, Warwick-Edinburgh Mental Well-Being Scale; HADS, 
Hospital Anxiety and Depression Scale; CD-RISC, Connor-Davidson Resilience Scale; IPAQ, International Physical Activity Questionnaire; CFS, Chalder 
Fatigue Scale.

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3.4.2 Exclusion criteria
Severe sensory disabilities.
Physical illnesses that do not allow participation in 
the sessions.
Severe mental disorders that make it difficult to participate in 
groups. This includes schizophrenia spectrum disorders, bipolar 
disorder with psychotic features, major depressive disorder with 
psychotic symptoms, or any other psychiatric condition that, in 
the opinion of the researcher, significantly impairs the participant’s 
ability to participate in group activities safely and effectively.
Travel, surgery, or any other incident known in advance that 
does not allow the participant to complete at least 80% of 
the sessions.
Language difficulties.
3.5 Randomization and blinding
The participants will be  randomly assigned to either the 
intervention or the control group by the external researcher (MC), 
using computer-generated random numbers. The participant groups 
and personnel (research team) will not be blinded given the difficulty 
of masking the conditions.
3.6 Intervention
3.6.1 Intervention group
The multicomponent intervention was developed by an expert 
committee consisting of: psychologists, nurses, physiotherapists and 
FIGURE 2
Consolidated Standards of Reporting Clinical Trial (CONSORT) flow chart. WEMWBS, Warwick-Edinburgh Mental Well-Being Scale; HADS, Hospita 
Anxiety and Depression Scale; CD-RISC, Connor-Davidson Resilience Scale; IPAQ, International Physical Activity Questionnaire; CFS, Chalder Fatigue 
Scale.

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people with Long COVID. It was developed following the framework 
of Central Sensitivity Syndrome, using empirical evidence and 
contextual information.
The psycho-education will consist of 9 sessions of 90 min: one 
per week, in groups with a maximum of 16 participants. The topics 
covered during these sessions with a specialized therapist will 
include: (1) education in neuroscience relating to the 
symptomatology of Long COVID; (2) Mindfulness; (3) Cognitive-
Behavioral Therapy; and (4) Strategies for self-healing. The physical 
rehabilitation will consist of 9 sessions of 60 min: one per week, 
conducted by an expert physiotherapist. Each session will work on 
4 areas, following a progressive approach: (1) warm-up and aerobic 
exercises (25 min); (2) functional and muscle-strengthening 
exercises (10 min); (3) proprioception exercises (10 min); and (4) 
breathing exercises (10 min). In order to address the variability of 
symptomatology and functional capacity as a function of age, 
we have planned to individually tailor physical activity interventions 
based on the baseline condition and needs of each participant. This 
personalized approach aims to ensure that all participants, 
regardless of age, can safely and effectively participate in the 
program (see Table 1).
To ensure fidelity to the intervention and adherence of the 
participants, a series of exercises to be done at home after each 
session is contemplated. In addition, reminders will be  sent to 
participants about upcoming sessions to encourage them to attend, 
and attendance will be  registered for each of the sessions (see 
Table 1).
3.6.2 Control group
Participants in the control group will complete the same research 
questionnaires as those in the intervention group and during the same 
period (January to September 2025). Participants in the control group 
will be placed on a waiting list to receive the intervention once its 
effectiveness has been demonstrated.
3.7 Monitoring procedure and risk 
participants
This clinical trial does not test participants for medications or 
perform any invasive tests. It can therefore be considered low risk 
and no specific insurance will be taken out. However, the research 
team agrees that in the case of detecting a participant with a clear 
risk, such as depression, or with a re-exacerbation of Long COVID 
symptomatology, such as dyspnoea, the therapist, physiotherapist 
and research team must inform the participant’s referring doctor/
nurse at their primary health care center. If the participant suffers 
a crisis or an exacerbation that requires urgent attention, either 
during the intervention sessions or the study, the emergency 
service of the primary care center where the sessions are taking 
place will be  notified in order to immediately assess the 
participant’s condition. A member of the participant’s family will 
also be  contacted if necessary, and/or if requested by the 
participant. Confidentiality will be  maintained at all times to 
avoid the stigmatization of the participant.
3.8 Outcomes measures
3.8.1 Primary outcomes
Quality of life will be the primary outcome and will be measured 
using the EuroQol5D-5L scale (19). A review of the literature 
concluded that this scale has excellent psychometric properties and 
covers a wide range of populations, conditions and contexts (22). It 
has also been used in several studies of psycho-educational and 
physical rehabilitation interventions in individuals with Long COVID 
(9, 14).
The scale analyses five health dimensions, with one item per 
dimension: mobility (MO), self-care (SC), usual activities (UA), pain/
discomfort (PD) and anxiety/depression (AD). Each item has three 
levels of severity: no problems, some or moderate problems, and 
severe problems (19). The second part of the EQ-5D consists of a 
20-centimeter, millimeter vertical Visual Analog Scale (VAS) ranging 
from 0 (the worst imaginable health) to 100 (the best imaginable 
health) (19).
3.8.2 Secondary outcomes
Well-being will be assessed using the Warwick-Edinburgh Mental 
Well-Being Scale (WEMWBS); this is a 5-point Likert-type scale 
comprising 14 items. The total score ranges from 14 to 70 points. 
Higher scores indicate higher levels of mental well-being. The Spanish 
validation showed that, on the original scale, a confirmatory factor 
analysis adjusted to a one-factor model (CFI = 0.974; TLI = 0.970; 
RMSEA = 0.059; v2 = 584.82; df = 77; p = 0.001). This scale also has a 
high degree of internal consistency (Cronbach’s alpha = 0.930; 
Guttman’s lambda-2 = 0.932) (23).
Mental health problems, such as anxiety and depression, will 
be assessed using the Hospital Anxiety and Depression Scale (HADS) 
(24). This is a 4-point Likert-type scale (0–3) with a total score ranging 
from 0 to 21 for each subscale, in which higher scores are indicative 
of greater symptom severity. The Spanish validation reported a 
Cronbach’s alpha of 0.90 for the whole scale, 0.84 for the Depression 
subscale, and 0.85 for the Anxiety subscale (24).
Resilience will be  measured using the Connor-Davidson 
Resilience Scale (CD-RISC) (25, 26). This is a self-administered 
scale consisting of 10 Likert-type items with five response options 
(0 = not true, 1 = rarely true, 2 = sometimes true, 3 = often true, 
and 4 = true most of the time). The scale measures the ability to 
cope with stress and is designed for use with clinical samples. The 
scale score correlations range from 0.45 to 0.69, and Cronbach’s 
alpha was 0.85 (25). Higher scores indicate higher levels of 
resilience (25).
Physical condition will be  assessed using the International 
Physical Activity Questionnaire (IPAQ) (27) and the Chalder Fatigue 
Scale (28). The short-self-administered version of the IPAQ consists 
of five questions about the frequency, duration and intensity (vigorous 
and moderate) of physical activity in the last 7 days, as well as the time 
spent walking and sitting on weekdays. The specificity of the 
questionnaire for detecting non-compliance with physical activity 
recommendations is 75%. The sensitivity is 75%. The Kappa coefficient 
was low (= 0.33, p < 0.05) (27).
The Spanish version of the Chalder Fatigue Scale consists of 14 
items classified into 4 dimensions (low energy, sound problems, 
concentration problems, and subjective cognitive dysfunction). 

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TABLE 1  COVIDL/MIQoL outline of intervention sessions.
Session goals
Activities
Session 1: Introducing Long COVID and Central sensitization
	•	 Knowing the group
	•	 Explaining the study and the intervention
	•	 Introduction to the main concepts on which the intervention was based
	•	 Learning the concept of Long COVID and Central sensitization
	•	 Introduction to conscious breathing
Presentations
Describe the characteristics of the intervention and the key components on which it is 
based (1) Education in the neuroscience of Long COVID symptomatology; (2) 
Mindfulness; (3) Cognitive-Behavioral Therapy; (4) Self-care strategies
Explain the concept of Long COVID and Central sensitization
Deep breathing
Home practice: Practice Deep Breathing every day
Session 2: Physical rehabilitation
	•	 Reduction of sedentary behavior
	•	 Increase physical activity between 5 and 10% each week
Individual prescription of physical activity
Use the FITT model (F: Frequency, I: Intensity, T: Time, T: Type of activity)
Each session will work on strength, aerobic endurance, balance and/or walking and 
flexibility activities, following general recommendations for the prescription of 
physical exercise
Home practice: Exercises and physical activity
Session 3: The autonomous nervous system
	•	 Understanding the functioning of the nervous system and its relationship 
to symptomatology
	•	 Understanding the process of symptomatology maintenance in order to be able to 
reverse it
	•	 Introduction to mindfulness
Basic concepts: the brain. Basic anatomy and functions; the autonomous nervous 
system. The Relationship to: Long COVID symptomatology, Emotions, and Polyvagal 
Theory
Mindfulness: Introduction and Body Scan
Home practice: Practice Body Scan 3 times a week. Make a daily record of activity 
(energy management planning)
Session 4: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
Session 5: Effective personal energy management
	•	 Learning how to manage energy in order to improve the Long COVID symptoms
	•	 Learning about food that contributes to recovery
Pacing: effective energy management: energy, availability and expenditure
Types of fatigue. Classification of activities
Strategies to reduce energy-draining activities
Re-planning energy-enhancing activities
Feeding: types of food that contribute to recovery. Types of food that hinder recovery
Home practice: Identify and implement a feeding goal
Re-planning the daily record of activity (energy management planning)
Session 6: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
Session 7: Emotional management
	•	 Understanding how emotions function
	•	 Understanding the relationship between emotions and symptomatology in 
Long COVID
	•	 Learning to manage emotions
Concept of emotion; main emotions; functions of emotions; components of emotions. 
Emotional validation and management. How and why to validate emotions. 
Techniques to release unpleasant emotions
Exercise: Emotional Mindfulness
Home practice: Update and follow through with energy management planning. 
Identify a pleasant emotion each day
Session 8: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
Session 9: Cognitive management I
	•	 Understanding the functioning of thought
	•	 Understanding the relationship between thoughts and emotions and the 
symptomatology of Long COVID
	•	 Learning to manage thoughts to contribute to well-being
Thoughts: Nature of thoughts; relationship with emotions, behavior and 
symptomatology in Long COVID; cognitive distortions, and cognitive restructuring
Mindfulness: Through the storm
Home practice: Select two recurrent cognitive distortions and generate useful 
alternative thought. Select two words related to the symptomatology and search for 
kinder terms
Session 10: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
Session 11: Cognitive management II
	•	 Applying new, more useful ways of relating to thoughts
	•	 Learning to manage recurring concerns
Cognitive defusion; thought distraction; and recurrent concerns
Sleep habits
Home practice: Identify and implement a sleep health goal and a new healthy eating 
goal
Session 12: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
(Continued)

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Respondents rated each item according to their experience over the 
previous month, using a 4-point Likert scale. The total scores range 
from 0 to 42. Higher scores indicate greater severity of fatigue (28).
Finally, we will consider socio-demographic variables selected 
from the recommendations for harmonization of research in adults 
with COVID-19, established by 107 experts from 19 countries (29). 
The following variables will be included: age, gender, employment 
status, civil status, nucleus of conviviality, associated chronic 
pathology; COVID-19 vaccines, socio-economic data, country, and 
Long COVID symptoms.
The data will be managed by a statistician external to the research 
team and stored in a secure storage system belonging to the Consorci 
Sanitari de Terrassa.
3.9 Data analysis
A descriptive analysis of the variables will be carried out, analysing 
the frequencies and percentages of the qualitative variables; the mean 
and standard deviations for the quantitative normal distributed 
variables and the median; and the quartiles for the quantitative 
non-normally distributed variables. An intention-to-treat analysis will 
be performed. The values of the scores for the intervention and control 
groups will be  compared using the t-student test, if the score is 
normally distributed; using the Mann–Whitney test, if the score is 
not-normally distributed; and using the chi-square test, if the score 
has a cut-off. The effect size will be assessed using Cohen’s d, with its 
corresponding confidence intervals.
A linear regression and a logistic regression will be considered, 
including any other variables that could potentially affect the response. 
We will also stratify the results for factors, such as gender, age and 
symptomatology, while others may also be considered. The Kolmogorov–
Smirnov and Shapiro–Wilk tests will be used to assess normality. All the 
confidence intervals will be performed with a 95% confidence level. All 
analyses will be carried out using R software version 4.2.
4 Discussion
At present, there are still not enough interventions to improve the 
quality of life of individuals with Long COVID. In this protocol, 
we present a new, comprehensive, multicomponent intervention which 
can be developed and implemented at primary health care centers.
This study describes the design and implementation of an 
approach for evaluating the effectiveness of this innovative intervention.
One of the limitations of this study is that the long-term effects of 
the intervention may be  lost over time. We  propose making an 
evaluation after 6 months in order to assess the duration of the effect 
and to see whether it is necessary to either reinforce the intervention, 
or to repeat it after 6 or 7 months, in order to maintain the results.
Once the effectiveness of this intervention has been evaluated, the 
materials used during the sessions will be  made available for 
replication at interested primary care centers.
In summary, given the multidimensional impact of Long COVID 
and the limitations of current approaches, this project seeks to offer an 
innovative intervention that is aligned with the, often complex, needs 
of patients. There may, however, be some variation in the effectiveness 
of this intervention between groups due to differences between the 
teams involved. If this should be the case, we propose improving 
training in order to ensure that teams act as similarly as possible.
We expect that this intervention will offer a significant 
improvement in the quality of life and mental well-being of individuals 
with Long COVID and mark a significant step forward in the 
treatment of Long COVID.
We are currently finishing recruitment at www.clinicaltrials.gov. 
Any possible modifications to the study will be monitored by the 
TABLE 1  (Continued)
Session goals
Activities
Session 13: Acceptance of limits and self-compassion
	•	 Learning to accept one’s limits
	•	 Practicing self-compassion
Acceptance of personal limits: What is it and why is it necessary? Acceptance exercises
Self-compassion: What is it and why is it necessary?
Mindfulness: self-compassion exercise
Home practice: Identify and implement a new sleep health goal
Session 14: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
Session 15: Assertiveness, limits and gratitude
	•	 Learning to communicate assertively
	•	 Learning to set healthy limits in relationships with others
	•	 Learning to practice gratitude
Assertiveness: What is it and why is it necessary?
Communication styles. Exercise: how to explain what happens to people and what they 
need
Setting limits: How and why. Exercise: Saying “NO”
Gratitude: Benefits and Gratitude journal
Home practice: Identifying and implementing a new healthy eating goal. Start a 
gratitude journal
Session 16: Physical rehabilitation
Individual prescription of physical activity
Home practice: Exercises and physical activity
Session 17: Review of content
	•	 Review and integration of knowledge acquired
Review of the contents of all the sessions: contents, news tools, and doubts
Self-assessment exercise
Feedback from participants
Session 18: Physical rehabilitation
Individual prescription of physical activity

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innovation and research department of the Consorci Sanitari de 
Terrassa. These modifications will then be updated with the Quality 
Evaluation Agency of Catalonia and in the protocol registry for 
clinical trials. Any changes will be included in an article making a final 
assessment of the intervention.
5 Ethics and dissemination
The present protocol was reviewed and approved by the Ethics 
Committee Institutional Review Board of the “Consorci Sanitari de 
Terrassa” (Ref: 01-24-1CR-068), in June 2024. The study will be carried 
out in compliance with current legislation, following the Biomedical 
Research Law 14/2007. The confidentiality of participant data will 
be guaranteed in compliance with Organic Law 3/2018, of 5 December, 
on the Protection of Personal Data, and with the guarantee concerning 
digital rights and the General Data Protection Regulation (EU) 
679/2016. This intervention should not cause any physical or 
psychological harm to participants. However, a risk monitoring 
protocol has been developed, as explained above.
The results will be shared with individuals with Long Covid and 
their families through their primary healthcare center, while the 
research team will inform the local media. Additionally, healthcare 
professionals will receive specialized training to develop and 
implement the intervention in hospitals and primary care centers. 
Finally, we will disseminate our findings to the scientific community 
via conferences and publications.
Author contributions
MM: Conceptualization, Data curation, Investigation, Validation, 
Writing  – original draft, Writing  – review & editing. AA: 
Conceptualization, Supervision, Validation, Writing  – review & 
editing. CG: Investigation, Methodology, Writing – review & editing. 
MC-M: Investigation, Validation, Writing – review & editing. MG-A: 
Data curation, Investigation, Project administration, Writing – review 
& editing. MG-N: Investigation, Visualization, Writing – review & 
editing. CP: Investigation, Visualization, Writing – review & editing. 
RR: Data curation, Formal analysis, Methodology, Software, 
Visualization, Writing – review & editing. ML: Conceptualization, 
Data curation, Formal analysis, Investigation, Methodology, Software, 
Supervision, Validation, Writing – original draft, Writing – review & 
editing.
Funding
The author(s) declare that financial support was received for the 
research and/or publication of this article. This work was supported 
by the project “HUB d’ Innovació social i sanitària post-Covid-19” 
PT-082023-EP from the Servei Català de Salut de la Generalitat 
de Catalunya.
Acknowledgments
We would like to thank the primary care teams involved in the 
recruitment of participants.
Conflict of interest
The authors declare that the research was conducted in the 
absence of any commercial or financial relationships that could 
be construed as a potential conflict of interest.
Generative AI statement
The authors declare that no Gen AI was used in the creation of 
this manuscript.
Publisher’s note
All claims expressed in this article are solely those of the authors 
and do not necessarily represent those of their affiliated organizations, 
or those of the publisher, the editors and the reviewers. Any product 
that may be evaluated in this article, or claim that may be made by its 
manufacturer, is not guaranteed or endorsed by the publisher.
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