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Clinical Trials/ISRCTN12655391
ISRCTN12655391
Completed
未知

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

niversity College London Hospitals NHS Foundation Trust0 sites206 target enrollmentJuly 17, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Motor neuron disease
Sponsor
niversity College London Hospitals NHS Foundation Trust
Enrollment
206
Status
Completed
Last Updated
last year

Overview

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)

Registry
who.int
Start Date
July 17, 2017
End Date
April 30, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London Hospitals NHS Foundation Trust

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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