Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy (ACT) for post-COVID syndrome: a study protocol.

Authors

Nicole Carvalho, Michail Kalfas, Caroline Jolley, Gerrard F Rafferty, Oliver Pearson, Richard Emsley, Alan J Metcalfe, Barbara Barrett, Debbie Brewin, Lily Felton, Tasbiha Khan, Nicholas Hart, Emma L Duncan, Timothy Nicholson, Oliver C Witard, Rachael A Evans, Carole Beckwith, Trudie Chalder

Published in

BMJ open. Volume 16. Issue 8. Pages e122602. Aug 03, 2026. Epub Aug 03, 2026.

Abstract

Post-COVID syndrome (PCS) is an ongoing legacy of the SARS-CoV-2 pandemic. Defined as symptoms persisting beyond 12 weeks following SARS-CoV-2 infection unexplained by an alternative diagnosis, many individuals continue to experience symptoms for months post-infection. Fatigue, breathlessness, cognitive difficulties and sleep disturbances are all commonly reported, frequently impairing daily functioning and quality of life. Acceptance and commitment therapy (ACT), which enhances psychological flexibility and supports values-based behaviour change, has shown effectiveness across long-term health conditions. This protocol describes the evaluation of Balance-ACT as a novel, adapted ACT-based intervention to address the complex physical and psychological needs of people with PCS.
A randomised controlled trial (RCT), co-developed with people with PCS, will evaluate the efficacy and cost-effectiveness of Balance-ACT for PCS. A total of 196 adults with PCS will be recruited from specialist long COVID services within secondary care across NHS organisations in England and randomised 1:1 to Balance-ACT or treatment as usual (TAU). Balance-ACT consists of 10 therapist-delivered sessions delivered over 13 weeks. TAU comprises brief educational videos and a self-help leaflet for COVID-19 recovery. Outcomes will be assessed at 7, 14 and 20 weeks post-randomisation. The primary outcome is health-related quality of life, measured using the SF-36 Physical Component Score at 14 weeks post randomisation. Secondary outcomes include physical health-related quality of life at 20 weeks, perceived fatigue, clinical global improvement, sleep disturbance, cognitive functioning, depressive symptoms, anxiety symptoms, post-exertional malaise, breathlessness, muscle strength, muscle fatigue and heart-rate variability. Mediation analyses will examine whether the intervention leads to changes in psychological flexibility, fear-avoidance beliefs, damage beliefs, embarrassment-avoidance, symptom focusing, muscle strength and physical activity and whether these changes are associated with physical health outcomes. We will also conduct a nested qualitative study to explore participants' views of the intervention. Cost-effectiveness will be assessed by comparing health and social care service costs and quality of life outcomes between Balance-ACT and TAU at 20 weeks.
Ethical approval has been granted by the NHS Camberwell St Giles Research Ethics Committee (reference 23/LO/0941). The study results will be disseminated in peer-reviewed journals and presented at international conferences.
NCT06231238.

PMID:
42547235
Bibliographic data and abstract were imported from PubMed on 04 Aug 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.