Open this publication in new window or tab >>Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Sheffield, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Sheffield, England..
Kings Coll London, Inst Psychiat Psychol & Neurosci, Dept Hlth Serv & Populat Res, London, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
UCL, Div Psychiat, London, England..
UCL, Div Psychiat, London, England.;Priory Hosp North London, London, England..
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology.
Univ Strathclyde, Dept Psychol Sci & Hlth, Glasgow, Scotland..
Kings Coll London, Maurice Wohl Clin Neurosci Inst, London, England..
Kings Coll London, Inst Psychiat Psychol & Neurosci, Dept Psychol, London, England..
Kings Coll London, Inst Psychiat Psychol & Neurosci, Dept Hlth Serv & Populat Res, London, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
UCL, Div Psychiat, London, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
Univ Sheffield, Sheffield Ctr Hlth & Related Res, Clin Trials Res Unit, Sheffield, England..
Univ Sheffield, Sheffield Inst Translat Neurosci, Sheffield, England.;Univ Sheffield, NIHR Sheffield Biomed Res Ctr, Sheffield, England..
Univ Sheffield, Sheffield Inst Translat Neurosci, Sheffield, England.;Univ Sheffield, NIHR Sheffield Biomed Res Ctr, Sheffield, England..
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2025 (English)In: Health Technology Assessment, ISSN 1366-5278, E-ISSN 2046-4924, Vol. 29, no 51, article id 7339Article in journal (Refereed) Published
Abstract [en]
Background: Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Formal psychological therapies are not routinely part of United Kingdom standard motor neuron disease care due to a lack of evidence-based guidance resulting from a paucity of clinical trials. We aimed to evaluate the clinical and cost-effectiveness of Acceptance and Commitment Therapy plus usual care compared to usual care alone improving psychological health in people living with motor neuron disease.
Methods: We conducted qualitative interviews with 15 people living with motor neuron disease, 10 caregivers and 12 healthcare professionals. Findings were used to develop an Acceptance and Commitment Therapy intervention specifically for people living with motor neuron disease. Next, we examined its acceptability and feasibility in uncontrolled feasibility study with 29 people living with motor neuron disease. Findings from qualitative interviews with 14 people living with motor neuron disease and 11 therapists were used to revise the intervention. Finally, we conducted a multicentre, parallel, two-arm randomised controlled trial in 16 United Kingdom motor neuron disease care centres/clinics. Eligible participants were aged ≥ 18 years with motor neuron disease. Participants were randomly assigned (1 : 1) to receive up to eight sessions of Acceptance and Commitment Therapy plus usual care or usual care alone and followed up at 6 and 9 months post randomisation by blinded outcome assessors. The primary outcome was total score on the McGill Quality of Life Questionnaire-Revised at 6 months. Secondary outcomes included health status using the EuroQol-5 Dimensions, five-level version. Primary analyses were by intention to treat.
Results: Acceptance and Commitment Therapy was acceptable to people living with motor neuron disease, and was feasible to recruit participants, hence trial progression criteria were met. From September 2019 to August 2022, 191 participants were recruited: 97 were allocated to Acceptance and Commitment Therapy plus usual care and 94 to usual care alone. Mean age was 61.9 years (standard deviation 11.4), 58% were male and 95% were White/ White British. Acceptance and Commitment Therapy plus usual care was superior to usual care alone on the McGill Quality of Life Questionnaire-Revised at 6 months [adjusted mean difference 0.66 (95% confidence interval 0.22 to 1.10); Cohen's d = 0.46 (95% confidence interval 0.16 to 0.77); p = 0.003] and 9 months [adjusted mean difference 0.76 (95% confidence interval 0.30 to 1.22); Cohen's d = 0.53 (95% confidence interval 0.21 to 0.85); p = 0.001]. Mean differences in total costs and quality-adjusted life-years at 9 months between Acceptance and Commitment Therapy plus usual care versus usual care alone were not statistically significant [costs: £1019 (95% confidence interval -£34 to £2074); quality-adjusted life-years: 0.019 (95% confidence interval-0.07 to 0.05)]. The incremental cost-effectiveness ratio was £88,507/quality-adjusted life-year: this decreased to £13,817/quality-adjusted life-year in those with medium disease-related deterioration in subgroup analyses.
Conclusion: Acceptance and Commitment Therapy plus usual care is clinically effective at maintaining or improving psychological health, as measured by the McGill Quality of Life Questionnaire-Revised, in people living with motor neuron disease compared to usual care alone. It was not cost-effective overall when calculated using a standard health status measure (EuroQol-5 Dimensions, five-level version). However, it was cost-effective in a subgroup of people experiencing a medium rate of disease-related deterioration.
Place, publisher, year, edition, pages
National Institute for Health and Care Research (NIHR) Journals Library, 2025
National Category
Neurosciences Neurology
Identifiers
urn:nbn:se:uu:diva-571299 (URN)10.3310/JHGD7339 (DOI)001604655100001 ()41143590 (PubMedID)2-s2.0-105019999779 (Scopus ID)
2025-11-112025-11-112025-11-11Bibliographically approved