Title: A feasibility study and randomised controlled trial of acceptance and COMmitment therapy for people with Motor nEuroN Disease (COMMEND)
Funder: MND Association

Abstract: 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, singleblind, 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 postrandomisation 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).


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;NEUROLOGICAL