COMMEND

Study titleA feasibility study of acceptance and COMmitment therapy for people with Motor nEuroN Disease (COMMEND)
UK Chief InvestigatorDr Rebecca Gould
Research summaryBACKGROUND: 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: The aim is to assess the feasibility and acceptability of a manualised intervention based on Acceptance and Commitment Therapy (ACT) for people with MND.

METHODS: Prior to the feasibility study a manualised intervention based on ACT will be developed through a series of PPI workshops/interviews with people with MND, caregivers and healthcare professionals (approved by UCL REC ref. 13312/001). It is anticipated (subject to change based on patient and clinical input) that ACT will comprise up to 8 sessions, each lasting up to 1 hour, over 3 months; a minimum of 4 sessions being face-to-face (delivered to individuals within the MND clinic or participant's home or via videoconferencing) and up to 4 being delivered via online videos/DVDs (complemented by therapist support). The intervention will be evaluated in an open uncontrolled feasibility study (N = 28). Quantitative and qualitative data assessing the feasibility, acceptability, perceived value, suitability and relevance of the intervention and its format to people with MND will be collected at 0 and 6 months. Progression to Phase 2 (the future RCT) will occur if the intervention is deemed acceptable to people with MND as indicated by uptake and initial engagement (> = 80% of the target sample recruited in 4 months, with > = 70% completing at least 2 sessions). A separate application will be made to the HRA for approval to conduct Phase 2.
Inclusion/exclusion criteriaInclusion criteria:
i) Aged 18 and over; ii) Diagnosis of definite, laboratory-supported probable or probable familial or sporadic ALS using the World Federation of Neurology’s El Escorial criteria; iii) For caregivers: Primary caregiver of a person with MND.

Exclusion criteria:
i) Need for gastrostomy feeding or non-invasive ventilation (i.e. those in stages 4A or 4B of the King’s College London clinical staging system); ii) Diagnosis of dementia; iii) Currently receiving ongoing formal psychological therapy delivered by a formally trained psychologist or psychotherapist or unwilling to refrain from engaging in such formal psychological therapy during the receipt of ACT; iv) Insufficient understanding of English to enable engagement in ACT and completion of screening measures and patient-reported outcome measures; v) Lacking capacity to provide fully informed written consent, verbal consent (for those who cannot provide written consent), or consent via the use of a communication aid; vi) Need for treatment for severe psychiatric disorder such as schizophrenia or bipolar disorder, or those expressing suicidal ideation with active plans/suicidal behaviours and intent; vii) Other medical factors that could compromise full study participation such as intellectual disabilities or severe sensory deficits (e.g. visual blindness).
Current statusActive – recruiting
LocationsRoyal Free Hospital, London
Royal Hallamshire Hospital, Sheffield
The Walton Centre NHS Foundation Trust
National Hospital for Neurology & Neurosurgery – Queen Square; University College London Hospitals NHS Foundation Trust
Royal Preston Hospital
University Hospitals Plymouth NHS Trust
Royal Victoria Infirmary, Newcastle
The Royal London Hospital, Barts Health NHS Trust
Norfolk and Norwich University Hospital
King's College Hospital, London
Contact detailsCoordinating centre:
Kirsty Weeks, Email: k.weeks@ucl.ac.uk Phone: 020 7679 8052.
Recruitment group(s)Patients with MND.
Recruitment target(s)28 patients nationally.
Key datesRecruitment start date (actual): 06 July 2018
Recruitment end date (target): 31 October 2019
Follow-up end date (target):
Funder(s)NIHR: Health Technology Assessment and the Motor Neurone Diesase Association
SponsorUniversity College London
Study designInterventional; Qualitative research; Feasibility/ pilot study.
Intervention (if applicable)Psychological & Behavioural treatment
Phase (if applicable)Not applicable.
Outcome measuresIndicators of the acceptability of the intervention: uptake and engagement with/deliverability of the intervention.
Publications / Results reportsLinks will be provided when papers from this study are published.
Participant Information SheetDownload here