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An RCT of ACT for people with MND

  • Research type

    Research Study

  • Full title

    A randomised controlled trial of acceptance and COMmitment therapy for people with Motor nEuroN Disease (COMMEND)

  • IRAS ID

    255069

  • Contact name

    Rebecca Gould

  • Contact email

    r.gould@ucl.ac.uk

  • ISRCTN Number

    ISRCTN12655391

  • Clinicaltrials.gov Identifier

    Z6364106/2019/01/105, UCL Data Protection Registration Number

  • Duration of Study in the UK

    2 years, 10 months, 31 days

  • Research summary

    BACKGROUND: Motor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease predominantly affecting motor neurons from the motor cortex to the spinal cord, causing progressive wasting and weakening of muscles involved in mobilising, talking and breathing. Prognosis is poor: there is no known cure and median survival is 2-3 years following onset. Although prevalence rates of 44% for depression and 30% for anxiety have been observed, guidance on improving the psychological health is lacking.
    AIMS: To determine the clinical and cost effectiveness of Acceptance and Commitment Therapy (ACT) plus usual multidisciplinary care in comparison to usual multidisciplinary care alone for improving psychological health in people with MND.
    METHODS: Prior to this randomised controlled trial (RCT), a manualised intervention based on ACT was developed for people with MND through a series of PPI workshops/interviews with people with MND, caregivers and healthcare professionals (approved by UCL REC 13312/001). The intervention was evaluated in an uncontrolled feasibility study (approved by London Dulwich REC 18/LO/0227). Quantitative and qualitative data assessing the feasibility, acceptability, perceived value, suitability and relevance of the intervention and its format to people with MND were collected.
    The intervention will now be evaluated in an RCT. 188 participants will be randomly allocated to receive either ACT plus usual multidisciplinary care or usual multidisciplinary care alone. ACT will comprise up to 8 sessions, each lasting up to 1 hour, over 3 months, delivered to individuals within the MND clinic or participant’s home or via videoconferencing. Sessions will be supported by online or DVD audio recordings (complemented by therapist support). Quantitative data will be collected from patients and caregivers at 0 (baseline), 6 and 9 months, with the primary time-point being 6 months and the primary outcome measure being quality of life. Qualitative data will also be collected from patients and therapists.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    19/LO/0272

  • Date of REC Opinion

    30 Apr 2019

  • REC opinion

    Further Information Favourable Opinion