People with motor neurone disease (MND) will receive up to eight sessions of acceptance and commitment therapy (ACT) to see if it improves their psychological health and quality of life. MND progressively paralyses the body, and around half of those affected develop significant depression or anxiety. Existing psychological support is limited, and no therapy has been rigorously tested for this group. This trial addresses that gap by first developing an ACT intervention tailored to MND—focusing on psychological flexibility rather than trying to change unchangeable symptoms—then testing it in a large randomised controlled trial across 14 UK sites. If ACT proves effective, it would give clinicians a practical, evidence-based tool to help people with MND cope better with their diagnosis and daily life. The study also measures cost-effectiveness, so the NHS could decide whether to roll it out. For carers, the trial tracks burden and quality of life, recognising that MND affects entire families. The research is applied and directly aimed at improving care—not fundamental science—so success would mean a new, scalable therapy option for a condition that currently has few psychological interventions.
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PHASE 1 (months 1-19): Develop an ACT intervention with people with MND and clinicians through workshops/interviews and assess acceptability/feasibility in a feasibility study. 28 people with MND will receive ACT (see below [17-21]). Primary outcomes will be uptake and initial engagement. Secondary outcomes will be other acceptability/feasibility measures and patient-reported outcomes at pre- and post-treatment. Qualitative interviews will be conducted with up to 15 patients and all therapists. Progression to Phase 2 if 80%+ of target sample are recruited in 4 months, with 70%+ completing at least 2 sessions. PHASE 2 (months 20-54): Assess the clinical and cost effectiveness of ACT in a multicentre, single-blind, parallel, 2-arm RCT, with an internal pilot in months 20-29 to assess the feasibility of recruiting 71 participants, with 70%+ in the ACT arm completing at least 2 sessions by then. SETTING: Community. PARTICIPANTS: 188 people with MND from 14 sites. INCLUSIONS: Diagnosis of definite/probable/lab-supported probable MND (diagnostically synonymous with ALS [1, 81]); aged 18+; all eligible with respect to mood as per the Brief. EXCLUSIONS: Need for gastrostomy feeding or non-invasive ventilation; diagnosis of dementia; already receiving psychotherapy; unable to communicate in English; lacking capacity to give informed consent; severe psychiatric disorder. INTERVENTION: ACT adapted for people with MND plus usual care. Therapists in psychology services will be trained to deliver up to 8 face-to-face/video sessions over 3 months under regular supervision. COMPARATOR: Usual care RANDOMISATION: 1:1 stratified randomisation via the CTU's online system. PRIMARY OUTCOME: Psychological health measured by total score on McGill Quality of Life Questionnaire at 6 months post-randomisation (7). SECONDARY OUTCOMES: Patients: Existential and Psychological subscales of McGill Quality of Life Questionnaire; Modified Hospital Anxiety and Depression Scale for MND; EQ-5D-5L; Acceptance and Action Questionnaire-II to assess psychological flexibility/coping; cost effectiveness ratios/quality-adjusted life years using modified Client Service Receipt Inventory and EQ-5D-5L; non-physical adverse events plus self-harm; 9-month survival; ALS Functional Rating Scale-Revised; satisfaction with therapy (7, 87-91). Carers: EQ-5D-5L; Zarit Burden Interview (90, 92). Qualitative questionnaires will examine barriers to implementation in patients/therapists. TIMING OF OUTCOMES: Telephone/online/face-to-face assessment at 0, 6 and 9 months post-randomisation by a blind outcome assessor. SAMPLE SIZE: 188 patients will allow detection of an effect size of 0.44 SDs with a 2-sided alpha of 5% and 90% power, assuming: 20% attrition at 6 months; 0.01 intra-class correlation coefficient among ACT therapists; and 0.58 correlation between 0 and 6 months (13, 18, 84). TIMETABLE: -6-0 months: Gain HRA approval. 1-6 months: Develop intervention, train therapists, set up sites. 7-19 months: Feasibility study, gain HRA approval, RCT set-up. 20-39 months: Recruit to RCT (9.4 people per month). 20-48 months: Collect data. 49-54 months: Data analyses, dissemination. OUR TEAM: Has experience of successfully working together and leading NIHR multisite studies, with expertise in: MND (AAC/CG/CM/LG/PS); developing psychological interventions (CG/LG/LM/MS/RG); ACT (CG/LM/MS/RG); qualitative methods (VL); statistics (MB); health economics (TY); and trial methodology (all).
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