NCT06492590

Long COVID-19 Intervention (COVIDL/MIQoL)

Assessing a Multicomponent Intervention to Improve Quality of Life in Individuals With Long COVID-19 (COVIDL/MIQoL): A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Consorci Sanitari de Terrassa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long COVID-19

Interventions

Type	Name	Description
BEHAVIORAL	Multicomponent intervention	Multicomponent intervention based on psycho-education and physical rehabilitation.

Timeline

• Start date: 2025-01-17
• Primary completion: 2025-09-30
• Completion: 2025-11-30
• First posted: 2024-07-09
• Last updated: 2026-01-16

Locations

1 site across 1 country: Spain