A randomised controlled trial of Acceptance and Commitment Therapy plus usual care compared to usual care alone for improving psychological health in people with motor neuron disease (COMMEND): Study protocol

TY - JOUR

T1 - A randomised controlled trial of Acceptance and Commitment Therapy plus usual care compared to usual care alone for improving psychological health in people with motor neuron disease (COMMEND): Study protocol

AU - Gould, Rebecca

AU - Thompson, Benjamin

AU - Rawlinson, Charlotte

AU - Kumar, Pavithra

AU - White, David

AU - Serfaty, Marc

AU - Graham, Christopher

AU - McCracken, Lance

AU - Bursnall, Matt

AU - Bradburn, Mike

AU - Young, Tracey

AU - Howard, Robert

AU - Al-Chalabi, Ammar

AU - Goldstein, Laura

AU - Lawrence, Vanessa

AU - Cooper, Cindy

AU - Shaw, Pamela

AU - McDermott, Christopher

N1 - Funding Information: This RCT is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (grant number 16/81/01) and the Motor Neurone Disease Association (grant number Gould/Jul17/936–794). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care. The NIHR commissioned the research and had an initial role in stipulating brief details about the study design, but was otherwise not involved in study design, collection/analysis/interpretation of data or manuscript preparation, as were the Motor Neurone Disease Association. The Study Protocol has undergone full external peer review by the funding body as part of the peer review process. RG, MS and RH are supported by the NIHR University College London Hospitals Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London. AA-C, LG and VL are supported by the NIHR Maudsley Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. MBr, TY, CC, PS and CM are supported by the NIHR Sheffield Biomedical Research Centre. This project is supported through the following funding organisations under the aegis of JPND - www.jpnd.eu (United Kingdom, Medical Research Council (MR/L501529/1; MR/R024804/1) and Economic and Social Research Council (ES/L008238/1) and through the Motor Neurone Disease Association, My Name’5 Doddie Foundation, and Alan Davidson Foundation. Publisher Copyright: © 2022, The Author(s).

PY - 2022/11/15

Y1 - 2022/11/15

N2 - Background: Motor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease that predominantly affects motor neurons from the motor cortex to the spinal cord and causes progressive wasting and weakening of bulbar, limb, abdominal and thoracic muscles. Prognosis is poor and median survival is 2–3 years following symptom onset. Psychological distress is relatively common in people living with MND. However, formal psychotherapy is not routinely part of standard care within MND Care Centres/clinics in the UK, and clear evidence-based guidance on improving the psychological health of people living with MND is lacking. Previous research suggests that Acceptance and Commitment Therapy (ACT) may be particularly suitable for people living with MND and may help improve their psychological health. Aims: To assess the clinical and cost-effectiveness of ACT modified for MND plus usual multidisciplinary care (UC) in comparison to UC alone for improving psychological health in people living with MND. Methods: The COMMEND trial is a multi-centre, assessor-blind, parallel, two-arm RCT with a 10-month internal pilot phase. 188 individuals aged ≥ 18 years with a diagnosis of definite, laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis, and additionally the progressive muscular atrophy and primary lateral sclerosis variants, will be recruited from approximately 14 UK-based MND Care Centres/clinics and via self-referral. Participants will be randomly allocated to receive up to eight 1:1 sessions of ACT plus UC or UC alone by an online randomisation system. Participants will complete outcome measures at baseline and at 6- and 9-months post-randomisation. The primary outcome will be quality of life at six months. Secondary outcomes will include depression, anxiety, psychological flexibility, health-related quality of life, adverse events, ALS functioning, survival at nine months, satisfaction with therapy, resource use and quality-adjusted life years. Primary analyses will be by intention to treat and data will be analysed using multi-level modelling. Discussion: This trial will provide definitive evidence on the clinical and cost-effectiveness of ACT plus UC in comparison to UC alone for improving psychological health in people living with MND. Trial registration: ISRCTN Registry, ISRCTN12655391. Registered 17 July 2017, https://www.isrctn.com/ISRCTN12655391. Protocol version: 3.1 (10/06/2020).

AB - Background: Motor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease that predominantly affects motor neurons from the motor cortex to the spinal cord and causes progressive wasting and weakening of bulbar, limb, abdominal and thoracic muscles. Prognosis is poor and median survival is 2–3 years following symptom onset. Psychological distress is relatively common in people living with MND. However, formal psychotherapy is not routinely part of standard care within MND Care Centres/clinics in the UK, and clear evidence-based guidance on improving the psychological health of people living with MND is lacking. Previous research suggests that Acceptance and Commitment Therapy (ACT) may be particularly suitable for people living with MND and may help improve their psychological health. Aims: To assess the clinical and cost-effectiveness of ACT modified for MND plus usual multidisciplinary care (UC) in comparison to UC alone for improving psychological health in people living with MND. Methods: The COMMEND trial is a multi-centre, assessor-blind, parallel, two-arm RCT with a 10-month internal pilot phase. 188 individuals aged ≥ 18 years with a diagnosis of definite, laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis, and additionally the progressive muscular atrophy and primary lateral sclerosis variants, will be recruited from approximately 14 UK-based MND Care Centres/clinics and via self-referral. Participants will be randomly allocated to receive up to eight 1:1 sessions of ACT plus UC or UC alone by an online randomisation system. Participants will complete outcome measures at baseline and at 6- and 9-months post-randomisation. The primary outcome will be quality of life at six months. Secondary outcomes will include depression, anxiety, psychological flexibility, health-related quality of life, adverse events, ALS functioning, survival at nine months, satisfaction with therapy, resource use and quality-adjusted life years. Primary analyses will be by intention to treat and data will be analysed using multi-level modelling. Discussion: This trial will provide definitive evidence on the clinical and cost-effectiveness of ACT plus UC in comparison to UC alone for improving psychological health in people living with MND. Trial registration: ISRCTN Registry, ISRCTN12655391. Registered 17 July 2017, https://www.isrctn.com/ISRCTN12655391. Protocol version: 3.1 (10/06/2020).

UR - http://www.scopus.com/inward/record.url?scp=85141961582&partnerID=8YFLogxK

U2 - 10.1186/s12883-022-02950-5

DO - 10.1186/s12883-022-02950-5

M3 - Article

SN - 1471-2377

VL - 22

JO - BMC Neurology

JF - BMC Neurology

IS - 1

M1 - 431

ER -