tetano
Editor, Senior Moderator
BMJ Open
. 2026 Aug 3;16(8):e122602.
doi: 10.1136/bmjopen-2026-122602.
Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy (ACT) for post-COVID syndrome: a study protocol
Nicole Carvalho[SUP] 1 [/SUP], Michail Kalfas[SUP] 1 2 [/SUP], Caroline Jolley[SUP] 3 4 [/SUP], Gerrard F Rafferty[SUP] 5 [/SUP], Oliver Pearson[SUP] 6 [/SUP], Richard Emsley[SUP] 6 7 [/SUP], Alan J Metcalfe[SUP] 3 8 [/SUP], Barbara Barrett[SUP] 9 [/SUP], Debbie Brewin[SUP] 1 [/SUP], Lily Felton[SUP] 1 [/SUP], Tasbiha Khan[SUP] 1 [/SUP], Nicholas Hart[SUP] 3 10 11 [/SUP], Emma L Duncan[SUP] 12 13 [/SUP], Timothy Nicholson[SUP] 14 [/SUP], Oliver C Witard[SUP] 3 [/SUP], Rachael A Evans[SUP] 15 [/SUP], Carole Beckwith[SUP] 1 [/SUP], Trudie Chalder[SUP] 16 [/SUP]
Affiliations
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.
Keywords: Fatigue; Post-Acute COVID-19 Syndrome; Quality of Life; Randomized Controlled Trial.
. 2026 Aug 3;16(8):e122602.
doi: 10.1136/bmjopen-2026-122602.
Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy (ACT) for post-COVID syndrome: a study protocol
Nicole Carvalho[SUP] 1 [/SUP], Michail Kalfas[SUP] 1 2 [/SUP], Caroline Jolley[SUP] 3 4 [/SUP], Gerrard F Rafferty[SUP] 5 [/SUP], Oliver Pearson[SUP] 6 [/SUP], Richard Emsley[SUP] 6 7 [/SUP], Alan J Metcalfe[SUP] 3 8 [/SUP], Barbara Barrett[SUP] 9 [/SUP], Debbie Brewin[SUP] 1 [/SUP], Lily Felton[SUP] 1 [/SUP], Tasbiha Khan[SUP] 1 [/SUP], Nicholas Hart[SUP] 3 10 11 [/SUP], Emma L Duncan[SUP] 12 13 [/SUP], Timothy Nicholson[SUP] 14 [/SUP], Oliver C Witard[SUP] 3 [/SUP], Rachael A Evans[SUP] 15 [/SUP], Carole Beckwith[SUP] 1 [/SUP], Trudie Chalder[SUP] 16 [/SUP]
Affiliations
- PMID: 42547235
- DOI: 10.1136/bmjopen-2026-122602
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.
Keywords: Fatigue; Post-Acute COVID-19 Syndrome; Quality of Life; Randomized Controlled Trial.