Gould, Rebecca;
Thompson, BJ;
Rawlinson, C;
Kumar, P;
White, D;
Serfaty, MA;
Graham, CD;
... McDermott, CJ; + view all
(2022)
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.
BMC Neurology
, 22
, Article 431. 10.1186/s12883-022-02950-5.
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Abstract
Background: Motor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease that predomi‑ nantly afects motor neurons from the motor cortex to the spinal cord and causes progressive wasting and weaken‑ ing 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 psycho‑ therapy 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-efectiveness of ACT modifed 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 defnite, 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 fexibility, 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 inten‑ tion to treat and data will be analysed using multi-level modelling. Discussion: This trial will provide defnitive evidence on the clinical and cost-efectiveness of ACT plus UC in com‑ parison 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/ISRCTN1265 5391. Protocol version: 3.1 (10/06/2020)
| Type: | Article |
|---|---|
| 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 |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s12883-022-02950-5 |
| Publisher version: | https://doi.org/10.1186/s12883-022-02950-5 |
| Language: | English |
| Additional information: | Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| Keywords: | Motor neuron disease, Acceptance and Commitment Therapy, Psychological health, Quality of life, RCT |
| UCL classification: | UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry > Mental Health of Older People UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10158283 |
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