Abstract
Introduction In adults, muscle disease (MD) is often a chronic long-term condition with no definitive cure. It causes wasting and weakness of the muscles resulting in a progressive decline in mobility, alongside other symptoms, and is typically associated with reduced quality of life (QoL). Previous research suggests that a psychological intervention, and in particular Acceptance and Commitment Therapy (ACT), may help improve QoL in MD. ACT is a newer type of cognitive behavioural treatment that aims to improve QoL by virtue of improvement in a process called psychological flexibility. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a guided self-help ACT programme for improving QoL in people with MD. Main secondary outcomes are mood, symptom impact, work and social adjustment and function at 9-week follow-up. Methods and analysis Acceptance and Commitment Therapy for Muscle Disease is an assessor-blind, multicentre, two-armed, parallel-group RCT to assess the efficacy of ACT plus standard medical care (SMC) compared with SMC alone. Individuals with a diagnosis of one of four specific MDs, with a duration of at least 6 months and with mild to moderate anxiety or depression (Hospital Anxiety and Depression Scale score ≥8) will be recruited from UK-based MD clinics and MD patient support organisations. Participants will be randomised to either ACT plus SMC or SMC alone by an independent randomisation service. Participants will be followed up at 3, 6 and 9 weeks. Analysis will be intention to treat, conducted by the trial statistician who will be blinded to treatment allocation. Ethics and dissemination The study has received full ethical approval. Study results will be disseminated via peer-reviewed publications, conference presentations and journal articles. Data obtained from the trial will enable clinicians and health service providers to make informed decisions regarding the efficacy of ACT for improving QoL for patients with MD. Trial registration number NCT02810028. Protocol version V.11 (4 April 2017).
| Original language | English |
|---|---|
| Article number | e022083 |
| Number of pages | 10 |
| Journal | BMJ open |
| Volume | 8 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 3 Oct 2018 |
Funding
1Department of Neurology, King’s College Hospital, London, UK 2Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK 3Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK 4Leeds Institute of Health Sciences, University of Leeds, Leeds, UK 5Royal London Hospital, Barts and the London MND Centre, London, UK Acknowledgements We are grateful to Daniel Thomas (PPI representative) and MD-UK representatives who commented on several drafts of the study materials at different stages. We are also grateful to our physiotherapy collaborators (Joanna Reffin, Emily Jay, Sunitha Narayan, Jade Donnelly, Leslie Richards and Kelly Orr). Contributors MRR, CDG, SN, LM, AR and TC obtained funding for the study. MRR, SN, CV, VE, LM, CDG, AR and TC contributed to the study protocol. MRR and TC are responsible for overall supervision. All authors read, contributed and approved the final manuscript. funding National Institute for Health Research (NIHR) Research for Patient Benefit grant (reference no PB-PG-061331085). Muscular Dystrophy UK have been partners from the commencement of the study and funded the trial therapist. The trial is sponsored by King’s College Hospital NHS Foundation Trust and cosponsored by King’s College London. Competing interests None declared. Patient consent Not required. Ethics approval Health Research Authority (London-Camberwell St Giles Research Ethics Committee, 16/LO/0609). Provenance and peer review Not commissioned; externally peer reviewed. open access This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/.
Keywords
- acceptance and commitment therapy
- adult
- muscle diseases
- quality of life
- randomised controlled trial