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Long COVID-19COVIDL/MIQoLNCT06492590

Long COVID-19 Intervention (COVIDL/MIQoL)

A study testing Multicomponent intervention in people with Long COVID-19, run by Consorci Sanitari de Terrassa at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Long COVID-19
What is being tested?
Multicomponent intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteSpain
Study dates
17 Jan 2025to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals diagnosed with Long COVID-19
  • Present discomfort with the situation
  • Individuals aged 18 to 75
  • Sign the informed consent form

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

Other trials in Spain

About this study

Official title: 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).
Read the 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
Being tested
Multicomponent intervention
Keywords
Physical Rehabilitation, Psychological Intervention, Randomized Controlled Trial, Long COVID-19
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent interventionBehavioural

    Also called COVID-L/MIQoLI

    Multicomponent intervention based on psycho-education and physical rehabilitation.

Study groups in NCT06492590
Study groupRoleWhat they receive
Intervention groupExperimentalA 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
Receives: Behavioral: Multicomponent intervention
Control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improved quality of life

    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

    Measured: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

Secondary outcomes (5)

  1. Improve well-being

    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

    Measured: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

  2. Decreased anxiety and depression

    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

    Measured: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

  3. Increased resilience

    Changes in level of resilience using the Connor-Davidson Resilience Scale (CD-RISC). Values range from 0 to 40 . Higher scores, better outcome

    Measured: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

  4. Improve physical activity

    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

    Measured: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

  5. Decreased fatigue

    Changes in level of fatigue scale using the Chalder Fatigue Scale (CFS). Values range from 0 to 42 . Higher scores, worse outcome.

    Measured: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start17 Jan 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492590
Sponsor's protocol ID
PT-082023-EP HUB
Acronym
COVIDL/MIQoL
Status last verified
Jan 2026
First submitted
8 Jul 2024
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.

    PubMed 29767329

  • Castellvi P, Forero CG, Codony M, Vilagut G, Brugulat P, Medina A, Gabilondo A, Mompart A, Colom J, Tresserras R, Ferrer M, Stewart-Brown S, Alonso J. The Spanish version of the Warwick-Edinburgh mental well-being scale (WEMWBS) is valid for use in the general population. Qual Life Res. 2014 Apr;23(3):857-68. doi: 10.1007/s11136-013-0513-7. Epub 2013 Sep 5.

    PubMed 24005886

  • Herrero MJ, Blanch J, Peri JM, De Pablo J, Pintor L, Bulbena A. A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):277-83. doi: 10.1016/s0163-8343(03)00043-4.

    PubMed 12850660

  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PubMed 12964174

  • Roman Vinas B, Ribas Barba L, Ngo J, Serra Majem L. [Validity of the international physical activity questionnaire in the Catalan population (Spain)]. Gac Sanit. 2013 May-Jun;27(3):254-7. doi: 10.1016/j.gaceta.2012.05.013. Epub 2012 Oct 24. Spanish.

    PubMed 23103093

  • Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.

    PubMed 25559796

  • Nury Nusdwinuringtyas, Kevin Triangto, Idrus Alwi, Faisal Yunus. The Validity and Reliability of Six Minute Walk Test in a 15 Meter Track. Indones J Phys Med Rehabil. 2022;10(02).

  • Morera M, Arevalo A, Garriga C, Corral-Magana M, Garcia-Arque MC, Gragea-Nocete M, Perez Diaz C, Roca R, Llistosella M. Assessing a multicomponent intervention to improve quality of life in individuals with Long COVID (COVIDL/MIQoL): study protocol for a randomized controlled trial. Front Public Health. 2025 May 19;13:1604971. doi: 10.3389/fpubh.2025.1604971. eCollection 2025.

    PubMed 40458104

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent intervention in people with Long COVID-19, run by Consorci Sanitari de Terrassa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved quality of life (time frame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492590, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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