Long COVID-19 Intervention (COVIDL/MIQoL) (COVIDL/MIQoL)

January 14, 2026 updated by: Maria Llistosella, Consorci Sanitari de Terrassa

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group

Participants in the control group will complete the same research questionnaires as the intervention group and for the same period.

Participants in the control group will be placed on a waiting list for the intervention once its efficacy has been demonstrated.
Experimental: Intervention group
A multicomponent intervention: The psycho-education will consist of 9 sessions of 90 minutes, one per week, in groups of a maximum of 16 participants.The topics that will be covered during the sessions with a specialized therapist will be: (1) education in neuroscience of the symptomatology of the Long COVID; (2) Mindfulness; (3) Cognitive-Behavioral Therapy; and (4) Strategies of self-healing. Physical rehabilitation will consist of 9 sessions of 60 minutes, one per week, in groups of a maximum of 16 participants, conducted by an expert physiotherapist. Each session will work on the following 4 blocks in a progressive approach: (1) warm-up and aerobic exercises (25 minutes); (2) functional and muscle strengthening exercises (10 minutes); (3) Proprioception exercises (10 minutes); and (4) breathing exercises (10 minutes). Answering the assessment questionnaires pre, post and 24 weeks of intervention follow-up
Behavioral: Multicomponent intervention
Multicomponent intervention based on psycho-education and physical rehabilitation.
Other Names:
  • COVID-L/MIQoLI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
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
Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
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
Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
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
Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
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.
Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Maria Llistosella, PhD, Primary Health Care, Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT-082023-EP HUB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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