A trial of acceptance and commitment therapy for people with motor neuron disease

Not Applicable

Completed

• Conditions: Motor neuron disease; Nervous System Diseases

• Registration Number: ISRCTN12655391
• Lead Sponsor: niversity College London Hospitals NHS Foundation Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36380299/ (added 23/11/2022) 2023 Results article in https://doi.org/10.1186/s40814-023-01354-7 Co-primary feasibility and acceptability outcomes (added 10/07/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38735299/ Effectiveness of ACT (added 17/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-17
• Study Completion: 2023-04-30
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 206

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1:<br>1. Uptake rate is recorded as the number of eligible participants who consent to participate in the study<br>2. Initial engagement rate is recorded as the number of eligible participants who complete at least 2 sessions<br><br>Phase 2:<br>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