Aguirre Elisa, Stott Josh, Charlesworth Georgina, Noone Deirdre, Payne Jacob, Patel Mina, Spector Aimee
Research and Development Department, North East London NHS Foundation Trust, Goodmayes Hospital, First floor, Maggie Lillie Suite, Ilford, IG3 8XJ UK.
Department of Clinical, Education and Health Psychology, University College London, London, UK.
Pilot Feasibility Stud. 2017 May 31;3:28. doi: 10.1186/s40814-017-0143-x. eCollection 2017.
Depression and dementia are major public health problems in the UK. Depression in early-stage dementia is very common and significantly reduces quality of life, speeds cognitive decline and increases functional impairment. Mindfulness-Based Cognitive Therapy (MBCT) is an effective depression prevention programme, and the National Institute for Clinical Excellence (NICE) has suggested that MBCT is a priority for implementation. Alongside this, there is emerging evidence demonstrating promising results in relation to the benefits of adapted mindfulness interventions for people with dementia, suggesting that it could be beneficial in reducing depressive symptoms and in slowing deterioration in cognitive functions such as sustained attention, distraction inhibition and task switching.
The design is a single-blind randomised controlled feasibility trial. Participants with mild to moderate depression and early stages of dementia will be recruited from the participating memory services. Participants will receive either immediate or delayed access to an 8-week MBCT programme. Participants will be assessed by a blind assessor and complete cognitive and mood-related outcome measures before and after the intervention. This feasibility study will test the trial design and assess recruitment, retention, acceptability and adherence, as well as providing preliminary efficacy data.
This study will inform the design and sample size for a future full randomised controlled trial (RCT), which will be carried out to determine the effectiveness of the intervention in reducing depressive symptoms in people with early stages of dementia.
ClinicalTrials.gov ISRCTN16382776.
抑郁症和痴呆症是英国主要的公共卫生问题。早期痴呆症患者中的抑郁症非常常见，会显著降低生活质量，加速认知衰退并增加功能障碍。基于正念的认知疗法（MBCT）是一种有效的抑郁症预防方案，英国国家卫生与临床优化研究所（NICE）建议将MBCT作为实施重点。与此同时，越来越多的证据表明，针对痴呆症患者的适应性正念干预措施具有良好效果，这表明它可能有助于减轻抑郁症状，并减缓诸如持续注意力、分心抑制和任务切换等认知功能的衰退。
本研究为单盲随机对照可行性试验。将从参与研究的记忆服务机构招募轻度至中度抑郁症且处于痴呆症早期阶段的参与者。参与者将被随机分配，立即或延迟接受为期8周的MBCT方案。参与者将由一名盲法评估者进行评估，并在干预前后完成认知和情绪相关的结局测量。这项可行性研究将测试试验设计，并评估招募、留存率、可接受性和依从性，同时提供初步疗效数据。
本研究将为未来的全随机对照试验（RCT）的设计和样本量提供信息，该试验将用于确定该干预措施在减轻早期痴呆症患者抑郁症状方面的有效性。
ClinicalTrials.gov ISRCTN16382776。
