Motor neuron disease Nervous System Diseases Motor neuron disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Diagnosis of familial or sporadic MND (or amyotrophic lateral sclerosis, which is diagnostically synonymous with MND) - diagnosed as definite, laboratory-supported probable or probable according to the World Federation of Neurology’s El Escorial criteria
Exclusion criteria
Exclusion criteria: 1. 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) 2. Comorbid diagnosis of any form of dementia using standard diagnostic guidelines 3. Already receiving ongoing formal psychological therapy (e.g. Cognitive Behavioural Therapy, psychodynamic psychotherapy, systemic therapy, counselling, etc) at the baseline assessment or unwilling to refrain from engaging in such formal psychological therapy during the receipt of ACT 4. Insufficient understanding of English to enable engagement in the intervention and completion of patient-reported outcome measures 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. Requiring treatment for a severe psychiatric disorder such as schizophrenia, bipolar disorder, or suicidal ideation with active plans/suicidal behaviours and intent 7. For Phase 2 only: Already participated in Phase 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: 1. Uptake rate is recorded as the number of eligible participants who consent to participate in the study 2. Initial engagement rate is recorded as the number of eligible participants who complete at least 2 sessions Phase 2: 1. Quality of life is measured using the McGill Quality of Life Questionnaire (Cohen et al., 1995) at baseline, 6 months and 9 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: 1. Acceptability: 1.1. Satisfaction rate is recorded as the number of eligible participants who consent to participate in the study and give ‘satisfactory’ ratings of therapy using the Satisfaction with Therapy and Therapist Scale-Revised (Oei et al., 2008) at 6 months. There is no set definition of what constitutes “satisfactory” and so this will be defined as a total score of 21 or more on the Satisfaction with Therapy subscale 1.2. Failure to recruit rate due to lack of acceptability is recorded as the number of eligible participants who refuse to consent to participate in the study during the 4-month recruiting period due to lack of acceptability of the intervention 1.3. Attrition rate due to lack of acceptability is recorded as the number of eligible participants who consent to participate in the study that drop out due to lack of acceptability of the intervention by 6 months 2. Feasibility: 2.1. Referral rate is recorded as the number of eligible referrals to the study overall during the 4-month recruiting period 2.2. Failure to recruit rate for reasons other than lack of acceptability is recorded as the number of eligible participants who refuse to consent to participate in the study during the 4-month recruiting period for reasons other than dissatisfaction with therapy 2.3. Attrition rate for reasons other than lack of acceptability is recorded as the number of eligible participants who consent to participate in the study that drop out for reasons other than dissatisfaction with therapy during the 4-month recruiting period 2.4. Deliverability of the intervention within the NHS is recorded as the number of therapy sessions offered (as opposed to completed) during the 3-month therapy period 3. Patient-reported outcome measures: 3.1. Quality of life is measured using the McGill Quality of Life Questionnaire (Cohen et al., 1995) at baseline and 6 months 3.2. Anxiety and depression is measured using the Modified Hospital Anxiety and Depression Scale | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales