Carvalho, Nicole, Kalfas, Michail, Jolley, Caroline, Rafferty, Gerrad F, Pearson, Oliver, Emsley, Richard, Metcalfe, Alan J, Barrett, Barbara, Brewin, Debbie, Felton, Lily, Khan, Tasbiha, Hart, Nicholas, Duncan, Emma L, Nicholson, Timothy, Witard, Oliver C, Evans, Rachael A, Beckwith, Carole and Chalder, Trudie (2026) Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy (ACT) for post-COVID syndrome: a study protocol. BMJ Open, 16 (8).

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Abstract

Introduction:
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.

Methods and analysis:
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.

Ethics and dissemination:
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.

Trial registration number NCT06231238.

Item Type:	Article
Identifier:	10.1136/bmjopen-2026-122602
Subjects:	Psychology > Counselling and psychotherapy Medicine and health > Mental health Medicine and health > Clinical medicine
Date Deposited:	26 Oct 2026
Dates:	Date Publication status 15 July 2026 Accepted 3 August 2026 Published
School, department or research centre:	School of Human and Social Sciences
URI:	https://repository.uwl.ac.uk/id/eprint/15580

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