If you are interested in taking part in the study, you can contact the central study team by emailing email@example.com . They will contact you to check your eligibility for the study and then identify a site that could accept you onto the study, and arrange a research referral from your clinical team to the research site. All study procedures can be completed “remotely”, which means by telephone or video-call, without the need for you to physically attend a clinical site.
|Study title||A randomised controlled trial of acceptance and COMmitment therapy for people with Motor nEuroN Disease (COMMEND)|
|UK Chief Investigator||Rebecca Gould|
|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 4 months, delivered to individuals within the MND clinic or participant’s home or via videoconferencing or telephone. Sessions will be supported by online 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.
The trial has been adapted to the coronavirus pandemic so that participation is possible without direct contact with the research team or therapists, to avoid the risk of infection.
|Inclusion/exclusion criteria||INCLUSION CRITERIA
1. Aged 18 and over.
2. Diagnosis of definite, laboratory-supported probable, clinically probable, or possible familial or sporadic ALS (which is diagnostically synonymous with MND) using the World Federation of Neurology’s El Escorial criteria, and additionally the Progressive Muscular Atrophy (PMA) and Primary Lateral Sclerosis (PLS) variants where appropriate investigation has excluded mimics of MND.
3. All people with MND will be eligible to participate with respect to the presence or absence of mood symptoms, irrespective of whether they are currently experiencing symptoms of depression or anxiety.
4. For caregivers: Primary caregiver of a person with MND.
1. Need for any form of gastrostomy feeding or non-invasive ventilation (NIV). That is, if a participant has a current clinical need then they will not be eligible to participate. For the RCT, a clinical need is defined as the participant being dependent upon percutaneous endoscopic gastronomy to meet all their nutrition and hydration needs, or meeting the NICE criteria for the offer of a trial of non-invasive ventilation as defined in NICE Guidance NG42, section 1.14.17. (These are markers of significantly reduced life expectancy and more advanced disease stage, and hence an indicator that participants might not survive the duration of the study.) Potential participants who use PEG feeds or receive NIV at earlier points in the disease course because of local practice or for reasons other than their MND diagnosis should not be excluded.
2. Diagnosis of dementia using standard diagnostic guidelines. (This would impede engagement with the intervention.)
3. Currently receiving ongoing formal psychological therapy delivered by a formally trained psychologist or psychotherapist and unwilling to refrain from engaging in such formal psychological therapy during the receipt of ACT. (Concurrent engagement may lead to conflicts in therapeutic approaches and goals.)
4. Insufficient understanding of English to enable engagement in ACT and completion of screening measures and patient-reported outcome measures. (Translators will not be employed due to difficulties inherent in ensuring adequate translation of discussions in therapy sessions, therapy materials, screening measures and outcome measures, insufficient time within the study time frame for materials to be translated, and unpredictable availability of interpreters.)
5. 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.
6. Need for treatment for severe psychiatric disorder such as schizophrenia or bipolar disorder, or expressing suicidal ideation with active plans/suicidal behaviours and imminent intent. (Other forms of treatment would be indicated in such instances.)
7. Other medical factors that could compromise full study participation such as intellectual disabilities or severe sensory deficits (e.g. visual blindness).
8. Previous participation in Phase 1 of COMMEND (feasibility study).
|Current status||Active – recruiting|
London (The Royal London Hospital)
London (UCL/National Hospital for Neurology and Neurosurgery)
London (King’s College Hospital)
Royal Preston Hospital
It may be possible to participate remotely if you are not at one of these locations. Please contact the study team using the details below to discuss this.
Other sites coming on board shortly - watch this space!
|Contact details||If you would like more information about the study, please email: firstname.lastname@example.org|
|Recruitment group(s)||Participant groups:
1. Patients with MND
2. Caregivers of patients with MND.
|Recruitment target(s)||188 participants.|
|Key dates||Actual opening date: 18 September 2019
Recruitment planned end date: 28th May 2021
|Funder(s)||NIHR: Health Technology Assessment grant award and the Motor Neurone Disease Association (MNDA)
|Sponsor||University College London|
|Study design||Randomised Interventional trial|
|Intervention (if applicable)||Treatment; Psychological & Behavioural|
|Phase (if applicable)||Not applicable|
|Outcome measures||The main outcome measure is McGill Quality of Life-Revised questionnaire.|
|Publications / Results reports||Links will be provided when papers are published.|
|Participant Information Sheet|