The goal of this clinical trial is to assess the effectiveness of a multicomponentintervention in individuals with Long COVID. The main questions it aims to answer are: - Does the intervention increase quality of life, mental well-being, resilience, and physical condition in individuals with Long COVID? - Does the intervention decrease anxiety, depressed mood, and fatigue in individuals with Long COVID? The researchers will compare the multicomponent intervention with a control (non-intervention) group.Participants will:• Participate in a multicomponent intervention for 9 weeks (2 sessions each week, one ofpsycho-education and one of physical rehabilitation).
Background The persistence of symptoms after acute SARS-CoV-2 infection, known as Long
COVID, has emerged as a wide-ranging public health challenge. This condition,
characterised by a wide range of physical and psychological symptoms that persist months
after initial recovery, significantly affects patients' quality of life.
To our knowledge, in the Primary Health Care setting, there are few published clinical
trials of multicomponent interventions involving psycho-educational and physical
rehabilitation activities to improve quality of life of individuals with Long COVID.
Therefore, the purpose of this trial is to assess the effectiveness of an innovative
multicomponent intervention, which includes psycho-education and physical rehabilitation
and which is in line with the complex needs of individuals with Long COVID.
The investigators hypothesize that participants with Long COVID, who receive the
multicomponent intervention (psycho-education and physical rehabilitation), will increase
their quality of life, mental well-being, resilience, and physical condition; and
decreased anxiety, depressed mood, and fatigue compared to the control group.
Method The study is a Randomized Controlled Trial (RCT). Participants will sign an
agreement to participate in the study and will be randomly allocated in control and
intervention groups by external researcher using a computer-generated random number.
The intervention will be carried out during January (2025)- September (2025).
Participants will follow a specific training consisting of 18 sessions: 9 sessions
(psycho-education) of 90 minutes, one per week conducted by specialized therapist; and 9
sessions (physical rehabilitation) of 60 minutes, one per week, conducted by an expert
physiotherapist.
The data collection will start in January 2025 and will finish in September 2025. Data
will be collected at baseline before the intervention (T0), after 9 weeks
post-intervention (T1) and 24 weeks follow-up (T2).
The assessment of the effectiveness of the intervention will be carried out using the
psychometric scale EuroQol5D-5L (as the primary outcome) which will allow the
investigators to determine changes in quality of live.
Using SD of the primary outcome EuroQol5D-5L, minimum sample size was calculated to be 34
participants in each group, using GRANMO
(https://www.imim.es/ofertadeserveis/software-public/granmo/). A follow-up loss rate of
10% was estimated.
Behavioral: Multicomponent intervention
Multicomponent intervention based on psycho-education and physical rehabilitation.
Other Name: COVID-L/MIQoLI
Inclusion Criteria:
- Individuals diagnosed with Long COVID-19
- Present discomfort with the situation
- Individuals aged 18 to 75
- Sign the informed consent form
Exclusion Criteria:
- Severe sensory deficits
- Physical illnesses that do not allow attendance at the sessions
- Severe mental disorders that make participation in groups inadvisable
- Travel, surgery, or other event that does not allow at least 80% of the sessions
- No comprehension of the language
Consorci Sanitari de Terrassa
Terrassa 3108286, Barcelona, Spain
Maria Llistosella, PhD, Principal Investigator
Primary Health Care, Consorci Sanitari de Terrassa