Skip to main content
OpenTrials
Completed

NCT Number: NCT06492590

Long COVID-19 Intervention (COVIDL/MIQoL)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Long COVID-19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multicomponent intervention

Behavioral

Multicomponent intervention based on psycho-education and physical rehabilitation.

Other names: COVID-L/MIQoLI

Primary outcomes

  1. Improved quality of life

    Time frame: 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 outcomes

  1. Improve well-being

    Time frame: 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

  2. Decreased anxiety and depression

    Time frame: 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

  3. Increased resilience

    Time frame: 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

  4. Improve physical activity

    Time frame: 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

  5. Decreased fatigue

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

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

Acronym: COVIDL/MIQoL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.