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临床试验/ISRCTN12655391
ISRCTN12655391已完成未知

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 个研究点目标入组 206 人开始时间: 2017年7月17日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
206

研究概览

简要总结

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)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
niversity College London Hospitals NHS Foundation Trust

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