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BMC Neurology
Published in: BMC Neurology 1/2022

Open Access 01-12-2022 | Care | Study protocol

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

Authors: Rebecca L. Gould, Benjamin J. Thompson, Charlotte Rawlinson, Pavithra Kumar, David White, Marc A. Serfaty, Christopher D. Graham, Lance M. McCracken, Matt Bursnall, Mike Bradburn, Tracey Young, Robert J. Howard, Ammar Al-Chalabi, Laura H. Goldstein, Vanessa Lawrence, Cindy Cooper, Pamela J. Shaw, Christopher J. McDermott

Published in: BMC Neurology | Issue 1/2022

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Abstract

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).
Appendix
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Metadata
Title
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
Authors
Rebecca L. Gould
Benjamin J. Thompson
Charlotte Rawlinson
Pavithra Kumar
David White
Marc A. Serfaty
Christopher D. Graham
Lance M. McCracken
Matt Bursnall
Mike Bradburn
Tracey Young
Robert J. Howard
Ammar Al-Chalabi
Laura H. Goldstein
Vanessa Lawrence
Cindy Cooper
Pamela J. Shaw
Christopher J. McDermott
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Care
Published in
BMC Neurology / Issue 1/2022
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-022-02950-5

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