Ali Afia, Francis Cheryl, Hoare Sarah, Carter Joanna, Goulden Nia, Clarke Caroline S, Charlesworth Georgina, Hoare Zoe, Acton Danny, Khanum Shafia, Onafalujo Akinwande, Jejeloye Adebayo, Brackley Kate, Aguirre Elisa, Spector Aimee
Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Department of Clinical, Educational & Health Psychology, University College London, London, UK.
BJPsych Open. 2025 Aug 1;11(5):e168. doi: 10.1192/bjo.2025.10764.
Group cognitive stimulation therapy (CST) has been shown to improve cognition and quality of life of people with dementia in multiple trials, but there has been scant research involving people with intellectual disability and dementia. This study aimed to assess the feasibility of conducting a randomised controlled trial of group CST for this population.
To assess the feasibility of participant recruitment and retention, the appropriateness of outcome measures, and the feasibility of group CST (adherence, fidelity, acceptability), as well as the feasibility of collecting data for an economic evaluation.
Participants were recruited from six National Health Service trusts in England and randomised to group CST plus treatment as usual (TAU) or TAU only. Cognition, quality of life, depression, and use of health and social care services were measured at baseline and at 8-9 weeks. Qualitative interviews with participants, carers and facilitators were used to explore facilitators of and barriers to delivery of CST. Trial registration number: ISRCTN88614460.
We obtained consent from 46 participants, and 34 (73.9%) were randomised: 18 to CST and 16 to TAU. All randomised participants completed follow-up. Completion rates of outcome measures (including health economic measures) were adequate; 75.7% of sessions were delivered, and 56% of participants attended ten or more. Fidelity of delivery was of moderate quality. CST was acceptable to all stakeholders; barriers included travel distance, carer availability and sessions needing further adaptations. The estimated cost per participant of delivering CST was £602.
There were multiple challenges including recruitment issues, a large dropout rate before randomisation and practical issues affecting attendance. These issues would need to be addressed before conducting a larger trial.
在多项试验中,团体认知刺激疗法(CST)已被证明可改善痴呆症患者的认知能力和生活质量,但针对智障和痴呆症患者的研究却很少。本研究旨在评估针对该人群开展团体CST随机对照试验的可行性。
评估参与者招募与留存的可行性、结局指标的适用性、团体CST的可行性(依从性、保真度、可接受性),以及为经济评估收集数据的可行性。
从英国的六个国民保健服务信托机构招募参与者,并将其随机分为接受团体CST加常规治疗(TAU)组或仅接受TAU组。在基线和8 - 9周时测量认知、生活质量、抑郁以及健康和社会护理服务的使用情况。通过对参与者、护理人员和治疗师进行定性访谈,探讨CST实施的促进因素和障碍。试验注册号:ISRCTN88614460。
我们获得了46名参与者的同意,其中34名(73.9%)被随机分组:18名接受CST,16名接受TAU。所有随机分组的参与者均完成了随访。结局指标(包括健康经济指标)的完成率足够;75.7%的疗程得以实施完成,56%的参与者参加了十次或更多次疗程。实施的保真度质量中等。CST为所有利益相关者所接受;障碍包括出行距离、护理人员的可及性以及疗程需要进一步调整。提供CST的每位参与者估计成本为602英镑。
存在多个挑战,包括招募问题、随机分组前的高退出率以及影响参与度的实际问题。在开展更大规模的试验之前,需要解决这些问题。