Long COVID-19
Conditions
Keywords
Physical Rehabilitation, Psychological Intervention, Randomized Controlled Trial, Long COVID-19
Brief summary
The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention 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 of psycho-education and one of physical rehabilitation).
Detailed description
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.
Interventions
BEHAVIORALMulticomponent intervention
Multicomponent intervention based on psycho-education and physical rehabilitation.
Sponsors
Consorci Sanitari de Terrassa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No-blinded participant and personnel (research team).
Intervention model description
This study is a Randomized controlled trial with parallel arms. Participants will be randomly allocated either to an intervention group or control by the external researcher using computer-generated random numbers
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved quality of life | Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2) | Changes in level of quality of life using the EuroQol 5D-5L scale (EQ-5D-5L). Values range from 0 to 1 (full health). Higher scores, better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improve well-being | Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2) | Changes in level of well-being using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Values range from 14 to 70 . Higher scores, better outcome |
| Decreased anxiety and depression | Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2) | Changes in level of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Anxiety values range from 0 to 15 . Higher scores, worse outcome. Depression values range from 0 to 12. Higher scores, worse outcome |
| Increased resilience | Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2) | Changes in level of resilience using the Connor-Davidson Resilience Scale (CD-RISC). Values range from 0 to 40 . Higher scores, better outcome |
| Improve physical activity | Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2) | Changes in level of physical activity using the International Physical Activity Questionnaire (IPAQ). In each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate MET minutes a week multiply the MET value given (r walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. Higher scores, better outcome |
| Decreased fatigue | Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2) | Changes in level of fatigue scale using the Chalder Fatigue Scale (CFS). Values range from 0 to 42 . Higher scores, worse outcome. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMaria Llistosella, PhD
Primary Health Care, Consorci Sanitari de Terrassa
Outcome results
None listed