Long COVID-19 Intervention (COVIDL/MIQoL)

NCT06492590 | Completed

• 1 other identifier: PT-082023-EP HUB
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Long COVID-19

Keywords

Physical Rehabilitation; Psychological Intervention; Randomized Controlled Trial; Long COVID-19

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

• Improve well-being

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

• Decreased anxiety and depression

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

• Increased resilience

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

• Improve physical activity

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

• Decreased fatigue

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Multicomponent intervention BEHAVIORAL

Multicomponent intervention based on psycho-education and physical rehabilitation.

Also known as: COVID-L/MIQoLI

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: male, female, non-binary
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (8)

• 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.

  PMID: 29767329 BACKGROUND

• 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.

  PMID: 24005886 BACKGROUND

• 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.

  PMID: 12850660 BACKGROUND

• 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.

  PMID: 12964174 BACKGROUND

• 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.

  PMID: 23103093 BACKGROUND

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

  PMID: 25559796 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 40458104 DERIVED

Related Links

• Situació actual de la COVID-19 persistent a Catalunya. Càrrega estimada, recursos assistencials, experiències internacionals i àrees d'incertesa. Comitè Científic Assessor de la COVID-19

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Llistosella, PhD

  Primary Health Care, Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No-blinded participant and personnel (research team).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 9, 2024
• Study Start: January 17, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

ES (1)