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Post-COVID-19 SyndromeBalanceACTNCT06231238

Balance Acceptance and Commitment Therapy for Long COVID

A study testing Balance Acceptance and Commitment Therapy in people with Post-COVID-19 Syndrome and Long COVID, run by King's College London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-COVID-19 Syndrome, Long COVID
What is being tested?
Balance Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteUnited Kingdom
Study dates
4 Jun 2024to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College London

    Camberwell, London, SE5 8AF

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Trial Assessing the Efficacy of Balance Acceptance and Commitment Therapy (ACT) 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.

Being tested
Balance Acceptance and Commitment Therapy
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.

  • Balance Acceptance and Commitment TherapyBehavioural

    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.

Study groups in NCT06231238
Study groupRoleWhat they receive
Balance ACTExperimentalParticipants randomised to Balance ACT will receive 10 therapy sessions with a therapist.
Receives: Behavioral: Balance Acceptance and Commitment Therapy
Treatment as usualNo interventionInformation leaflet about PCS/LC.

What is being measured

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

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

    Measured: Week 14

Secondary outcomes (32)

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

    Measured: Week 0, 14 and 20

  2. Adult Service Use Schedule

    Measured: Week 0 and 20

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

    Measured: Week 0, 7, 14 and 20

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

    Measured: Week 14 and 20

  5. Pittsburgh Sleep Quality Index (PSQI)

    Measured: Week 0, 7, 14 and 20

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

    Measured: Week 0, 7, 14 and 20

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

    Measured: Week 0, 14 and 20

  8. Perceived Deficits Questionnaire (PDQ)

    Measured: Week 0, 7, 14 and 20

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

    Measured: Week 0, 7, 14 and 20

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

    Measured: Week 0, 7, 14 and 20

  11. Work and social adjustment scale (WSAS)

    Measured: Week 0, 7, 14 and 20

  12. Modified DePaul Post exertional malaise questionnaire

    Measured: Week 0, 7, 14 and 20

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

    Measured: Week 0, 14 and 20

  14. Nijmegen Questionnaire (NQ)

    Measured: Week 0, 14 and 20

  15. Dyspnoea-12

    Measured: Week 0, 14 and 20

  16. Modified Medical Research Council Dyspnea Scale (mMRC)

    Measured: Week 0, 14 and 20

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

    Measured: Week 0 and 14

  18. Muscle strength

    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.

    Measured: Week 0, 7, 14 and 20

  19. Muscle fatigue

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

    Measured: Week 0 and 14

  20. 1 minute sit-to-stand test

    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.

    Measured: Week 0 and 14

  21. 4 metre gait speed

    Measured: Week 0 and 14

  22. Short Physical Performance Battery (SPPB)

    Measured: Week 0 and 14

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

    Measured: Week 0, 7, 14 and 20

  24. Heartrate variability

    via electrocardiogram (ECG)

    Measured: Week 0 and 14

  25. Average Heart-rate

    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.

    Measured: Week 0 and 14

  26. Cognitive and Behavioural Responses Questionnaire (CBRQ)

    Measured: Week 0, 7, 14 and 20

  27. Comprehensive assessment of Acceptance and Commitment Therapy processes

    Measured: Week 0, 7, 14 and 20

  28. Quadricep Muscle Strength

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

    Measured: Week 0 and 14

  29. Post COVID Syndrome Recovery (Single Item)

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

    Measured: Week 7, 14 and 20

  30. Treatment Satisfaction Questionnaire

    Measured: Week 14

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

    Measured: Week 0, 7, and 20

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

    Measured: Week 0, 7, 14 and 20

Timeline

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

  1. First posted30 Jan 2024
  2. Study start4 Jun 2024
  3. Primary completion30 May 2026
  4. Study completion1 Aug 2026 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231238
Sponsor's protocol ID
326529
Acronym
BalanceACT
Status last verified
Jun 2026
First submitted
29 Jan 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated/analysed during the current study will be anonymised and deposited in King's Open Research Data System. Access to data will be restricted to protect participant confidentiality and comply with applicable data protection legislation. Data will be made available upon reasonable request following publication of the main trial results.

Publications

  • Carvalho N, Kalfas M, Jolley C, Rafferty GF, Pearson O, Emsley R, Metcalfe AJ, Barrett B, Brewin D, Felton L, Khan T, Hart N, Duncan EL, Nicholson T, Witard OC, Evans RA, Beckwith C, Chalder T. Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy (ACT) for post-COVID syndrome: a study protocol. BMJ Open. 2026 Aug 3;16(8):e122602. doi: 10.1136/bmjopen-2026-122602.

    PubMed 42547235

Questions about this trial

What is this clinical trial studying?

A study testing Balance Acceptance and Commitment Therapy in people with Post-COVID-19 Syndrome and Long COVID, run by King's College London at 1 site in United Kingdom.

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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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 United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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?

Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14 (time frame: Week 14). 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 NCT06231238, which also lists 1 linked publication.

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 2 Jul 2026.

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