Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND) : a multicentre, parallel, randomised controlled trial in the UK

Gould, Rebecca l and Mcdermott, Christopher j and Thompson, Benjamin j and Rawlinson, Charlotte v and Bursnall, Matt and Bradburn, Mike and Kumar, Pavithra and Turton, Emily j and White, David a and Serfaty, Marc a and Graham, Christopher d and Mccracken, Lance m and Goldstein, Laura h and Al-Chalabi, Ammar and Orrell, Richard w and Williams, Tim and Noad, Rupert and Baker, Idris and Faull, Christina and Lambert, Thomas and Chhetri, Suresh k and Ealing, John and Hanratty, Anthony and Radunovic, Aleksandar and Gunawardana, Nushan and Meadows, Gail and Gorrie, George h and Young, Tracey and Lawrence, Vanessa and Cooper, Cindy and Shaw, Pamela j and Howard, Robert j and Andreou, Penny and Androulaki-Korakaki, Dynameni and Blakeley, Claire and Bridges, Gary and Campbell, Iain and Davenport, Brittany and Dee, Annily and Drewry, Nicola and Flood, John and Fox, Annemieke and Girling, Melissa and Glew, Ruth and Hartley, Nick and Hocking, Sian and Howell, Mark and Keetharuth, Anju and Makin, Selina and Marsh, Jessica, COMMEND Collaboration Group (2024) Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND) : a multicentre, parallel, randomised controlled trial in the UK. The Lancet, 403 (10442). pp. 2381-2394. ISSN 0140-6736 (https://doi.org/10.1016/S0140-6736(24)00533-6)

[thumbnail of Gould-etal-Lancet-2024-Acceptance-and-Commitment-Therapy-plus-usual-care-for-improving-quality-of-life]
Preview
 Text. Filename: Gould-etal-Lancet-2024-Acceptance-and-Commitment-Therapy-plus-usual-care-for-improving-quality-of-life.pdf
Final Published Version
License: Creative Commons Attribution 4.0 logo
Download (871kB)| Preview

Abstract

Background Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Acceptance and Commitment Therapy (ACT) is a psychological therapy incorporating acceptance, mindfulness, and behaviour change techniques. We aimed to evaluate the effectiveness of ACT plus usual care, compared with usual care alone, for improving quality of life in people with motor neuron disease. Methods We conducted a parallel, multicentre, two-arm randomised controlled trial in 16 UK motor neuron disease care centres or clinics. Eligible participants were aged 18 years or older with a diagnosis of definite or laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis; progressive muscular atrophy; or primary lateral sclerosis; which met the World Federation of Neurology's El Escorial diagnostic criteria. Participants were randomly assigned (1:1) to receive up to eight sessions of ACT adapted for people with motor neuron disease plus usual care or usual care alone by a web-based system, stratified by site. Participants were followed up at 6 months and 9 months post-randomisation. Outcome assessors and trial statisticians were masked to treatment allocation. The primary outcome was quality of life using the McGill Quality of Life Questionnaire-Revised (MQOL-R) at 6 months post-randomisation. Primary analyses were multi-level modelling and modified intention to treat among participants with available data. This trial was pre-registered with the ISRCTN Registry (ISRCTN12655391). Findings Between Sept 18, 2019, and Aug 31, 2022, 435 people with motor neuron disease were approached for the study, of whom 206 (47%) were assessed for eligibility, and 191 were recruited. 97 (51%) participants were randomly assigned to ACT plus usual care and 94 (49%) were assigned to usual care alone. 80 (42%) of 191 participants were female and 111 (58%) were male, and the mean age was 63·1 years (SD 11·0). 155 (81%) participants had primary outcome data at 6 months post-randomisation. After controlling for baseline scores, age, sex, and therapist clustering, ACT plus usual care was superior to usual care alone for quality of life at 6 months (adjusted mean difference on the MQOL-R of 0·66 [95% CI 0·22–1·10]; d=0·46 [0·16–0·77]; p=0·0031). Moderate effect sizes were clinically meaningful. 75 adverse events were reported, 38 of which were serious, but no adverse events were deemed to be associated with the intervention. Interpretation ACT plus usual care is clinically effective for maintaining or improving quality of life in people with motor neuron disease. As further evidence emerges confirming these findings, health-care providers should consider how access to ACT, adapted for the specific needs of people with motor neuron disease, could be provided within motor neuron disease clinical services.

ORCID iDs

Gould, Rebecca l, Mcdermott, Christopher j, Thompson, Benjamin j, Rawlinson, Charlotte v, Bursnall, Matt, Bradburn, Mike, Kumar, Pavithra, Turton, Emily j, White, David a, Serfaty, Marc a, Graham, Christopher d ORCID logoORCID: https://orcid.org/0000-0001-8456-9154, Mccracken, Lance m, Goldstein, Laura h, Al-Chalabi, Ammar, Orrell, Richard w, Williams, Tim, Noad, Rupert, Baker, Idris, Faull, Christina, Lambert, Thomas, Chhetri, Suresh k, Ealing, John, Hanratty, Anthony, Radunovic, Aleksandar, Gunawardana, Nushan, Meadows, Gail, Gorrie, George h, Young, Tracey, Lawrence, Vanessa, Cooper, Cindy, Shaw, Pamela j, Howard, Robert j, Andreou, Penny, Androulaki-Korakaki, Dynameni, Blakeley, Claire, Bridges, Gary, Campbell, Iain, Davenport, Brittany, Dee, Annily, Drewry, Nicola, Flood, John, Fox, Annemieke, Girling, Melissa, Glew, Ruth, Hartley, Nick, Hocking, Sian, Howell, Mark, Keetharuth, Anju, Makin, Selina and Marsh, Jessica;
CORE (COnnecting REpositories)