Abstract
Background Chronic muscle diseases (MD) are progressive and cause wasting and weakness in muscles and are associated with reduced quality of life (QoL). The ACTMuS trial examined whether Acceptance and Commitment Therapy (ACT) as an adjunct to usual care improved QoL for such patients as compared to usual care alone. Methods This two-arm, randomised, multicentre, parallel design recruited 155 patients with MD (Hospital and Depression Scale ≥ 8 for depression or ≥ 8 for anxiety and Montreal Cognitive Assessment ≥ 21/30). Participants were randomised, using random block sizes, to one of two groups: standard medical care (SMC) (n = 78) or to ACT in addition to SMC (n = 77), and were followed up to 9 weeks. The primary outcome was QoL, assessed by the Individualised Neuromuscular Quality of Life Questionnaire (INQoL), the average of five subscales, at 9-weeks. Trial registration was NCT02810028. Results 138 people (89.0%) were followed up at 9-weeks. At all three time points, the adjusted group difference favoured the intervention group and was significant with moderate to large effect sizes. Secondary outcomes (mood, functional impairment, aspects of psychological flexibility) also showed significant differences between groups at week 9. Conclusions ACT in addition to usual care was effective in improving QoL and other psychological and social outcomes in patients with MD. A 6 month follow up will determine the extent to which gains are maintained.
| Original language | English |
|---|---|
| Pages (from-to) | 1-14 |
| Number of pages | 14 |
| Journal | Psychological Medicine |
| Early online date | 23 Feb 2022 |
| DOIs | |
| Publication status | E-pub ahead of print - 23 Feb 2022 |
Funding
Trudie Chalder acknowledges the financial support of the Department of Health via the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health award to the South London and Maudsley NHS Foundation Trust (SLaM) and the Institute of Psychiatry at King's College London. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Michael Rose, Christopher D. Graham, Nicola O'Connell, Chiara Vari, Victoria Edwards, Emma Taylor, Lance M. McCracken, Aleksander Radunovic, Wojtek Rakowicz, and Sam Norton have no financial disclosures to make. This study was funded by the 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, funded the trial therapist and aided patient recruitment. The funders had no role in the data analysis or writing of this paper. We thank all study participants for their time and acknowledge support by the staff at all referral sites. We thank the following members of the Trial Steering Committee (TSC) and Data Safety Monitoring Ethics Committee (DSMEC); David Hilton-Jones (chair), Richard Orrell, Wojtek Rakowicz*, Ross White, Bill Love (PPI representative), Keith Sullivan (*demitted from TSC and DSMEC to be trial recruitment centre). We are grateful to Daniel Thomas (PPI representative) and MD-UK representatives for their support throughout this trial. We would like to thank the UK FSHD Patient Registry for their role in patient recruitment. We would like to thank our physiotherapy collaborators (Joanna Reffin, Emily Jay, Sunitha Narayan, Jade Donnelly, Maddie Formoy, Leslie Richards and Kelly Orr), and Kimberley Allen-Philbey, clinical trials practitioner RLH.
Keywords
- acceptance and commitment therapy
- muscle diseases
- quality of life
- randomised controlled trial