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Active, Not Recruiting

NCT Number: NCT06231238

Balance Acceptance and Commitment Therapy for Long COVID

This randomised controlled trial aims to investigate the efficacy of a psychological intervention for long COVID (LC) / post-COVID-19 syndrome (PCS) called Balance Acceptance and Commitment Therapy (Balance ACT).

The primary objective of this trial is to investigate whether Balance-ACT improves quality of life over treatment as usual (i.e., self-help leaflet) in people with PCS/LC.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post-COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long COVID 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

Camberwell, London, SE5 8AF, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • LC/PCS diagnosis as defined by National Health Service (NHS) / National Institute for Health and Care Excellence (NICE) (i.e., symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis). A checklist will be used to ensure participants fulfil the diagnostic criteria as per the NICE guidelines
  • Ability to travel to the research site for the study assessments
  • Having registered with a General Practitioner (GP) in the United Kingdom (UK) and consent to provide their details for the study team to contact
  • Ability to provide informed consent
  • Ability to read and write English

Exclusion criteria

  • Current diagnosis of an active major mental health disorder likely to interfere with participation
  • Unstable alcohol / drug dependency
  • Unstable complications associated with LC/PCS
  • Past hospitalisation for COVID-19
  • Current or recent participation in other treatment intervention studies (<4 weeks after completion)
  • Currently receiving psychological support or psychotherapy
  • Pregnancy

Treatment and study plan

Balance Acceptance and Commitment Therapy

Behavioral

Balance-ACT is an ACT-based psychological intervention specifically designed for people with PCS/LC. Balance-ACT will use ACT techniques and mindfulness and will focus on establishing a balance psychologically and physiologically and regulating homeostasis. More specifically, Balance ACT will aim to regulate behaviours such as sleep, stress and activity, which can subsequently have an impact on homeostasis and physiology. Balance-ACT will also encourage people to live a values-based life and set goals according to their values.

Primary outcomes

  1. Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14

    Time frame: Week 14

Secondary outcomes

  1. EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)

    Time frame: Week 0, 14 and 20

  2. Adult Service Use Schedule

    Time frame: Week 0 and 20

  3. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: Week 0, 7, 14 and 20

  4. Modified Clinical Global Impressions Scale- Improvement (CGI-I)

    Time frame: Week 14 and 20

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Week 0, 7, 14 and 20

  6. Modified Patient Health Questionnaire-15 (PHQ-15)

    Time frame: Week 0, 7, 14 and 20

  7. Montreal cognitive assessment-telephone version (MoCA-T)

    Time frame: Week 0, 14 and 20

  8. Perceived Deficits Questionnaire (PDQ)

    Time frame: Week 0, 7, 14 and 20

  9. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: Week 0, 7, 14 and 20

  10. Generalised Anxiety Disorder-7 (GAD-7)

    Time frame: Week 0, 7, 14 and 20

  11. Work and social adjustment scale (WSAS)

    Time frame: Week 0, 7, 14 and 20

  12. Modified DePaul Post exertional malaise questionnaire

    Time frame: Week 0, 7, 14 and 20

  13. Post Traumatic Stress Disorder Checklist for DSM 5 (PCL-5)

    Time frame: Week 0, 14 and 20

  14. Nijmegen Questionnaire (NQ)

    Time frame: Week 0, 14 and 20

  15. Dyspnoea-12

    Time frame: Week 0, 14 and 20

  16. Modified Medical Research Council Dyspnea Scale (mMRC)

    Time frame: Week 0, 14 and 20

  17. Lung function (spirometry, Resting pulse oximetry; SpO2)

    Time frame: Week 0 and 14

  18. Muscle strength

    Time frame: Week 0, 7, 14 and 20

    Handgrip muscle strength: A handgrip dynamometer will be used to measure grip strength. The dynamometer will be placed in the participant's hand and the participant will be instructed to squeeze as hard as possible.

  19. Muscle fatigue

    Time frame: Week 0 and 14

    • Handgrip volitional fatigue: A digital grip force transducer will be used to assess volitional handgrip fatigue.
    • Quadriceps non-volitional fatigue: Quadriceps muscle endurance will be assessed non-volitionally using transcutaneous electrical stimulation.

  20. 1 minute sit-to-stand test

    Time frame: Week 0 and 14

    Participants will also be shown the Borg Rating of Perceived Exertion Scale and asked to rate their perceived breathlessness and leg fatigue prior to the start of the test, immediately after completion of the test, and following one minute of recovery.

  21. 4 metre gait speed

    Time frame: Week 0 and 14

  22. Short Physical Performance Battery (SPPB)

    Time frame: Week 0 and 14

  23. International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    Time frame: Week 0, 7, 14 and 20

  24. Heartrate variability

    Time frame: Week 0 and 14

    via electrocardiogram (ECG)

  25. Average Heart-rate

    Time frame: Week 0 and 14

    Average Heart-rate will be assessed from 5 minutes of a 10-minute resting 3 lead electrocardiogram (ECG). These short-term recordings provide a non-invasive measure of autonomic nervous system function.

  26. Cognitive and Behavioural Responses Questionnaire (CBRQ)

    Time frame: Week 0, 7, 14 and 20

  27. Comprehensive assessment of Acceptance and Commitment Therapy processes

    Time frame: Week 0, 7, 14 and 20

  28. Quadricep Muscle Strength

    Time frame: Week 0 and 14

    Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation.

  29. Post COVID Syndrome Recovery (Single Item)

    Time frame: Week 7, 14 and 20

    A self-reported single item questionnaire "Do you consider yourself recovered from long COVID?"

  30. Treatment Satisfaction Questionnaire

    Time frame: Week 14

  31. Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 20

    Time frame: Week 0, 7, and 20

  32. Mental Component Summary (MCS) of the 36-item Short Form Health Survey (SF-36)

    Time frame: Week 0, 7, 14 and 20

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

A Randomised Controlled Trial Assessing the Efficacy of Balance Acceptance and Commitment Therapy (ACT) for Long COVID.

Acronym: BalanceACT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Jul 2, 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.

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