Tuijt Remco, Livingston Gill, Gould Rebecca L, Jones Rebecca, Verdaguer Elisabet Sole, Orgeta Vasiliki
Division of Psychiatry, University College London, London, UK.
BMJ Open. 2018 Feb 8;8(2):e021074. doi: 10.1136/bmjopen-2017-021074.
Depressive symptoms are common among people with dementia, impacting quality of life and cognitive and functional decline. Currently, little is known about the acceptability and feasibility of psychological interventions for people with mild dementia, with recent reviews identifying the need for further evidence. Developing and evaluating psychological interventions to prevent and treat these symptoms is, therefore, an important clinical and research priority. This protocol describes a study testing the acceptability and feasibility of a manual-based behavioural activation (BA) intervention for preventing and treating depressive symptoms in people with mild dementia. The aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial of clinical effectiveness of an eight-session intervention. The Intervention to prevent Depressive symptoms and promote well-being in EArly-stage dementia (IDEA) programme supports people with dementia and their family carers in identifying and scheduling enjoyable and meaningful activities.
Sixty people who have received a diagnosis of dementia of any type in the last 6 months will be recruited via memory clinics. Further criteria are a Mini-Mental State Examination score of ≥20, and a family carer who can assist with the intervention. Consenting participants will be randomised in a ratio of 2:1 to BA or to treatment as usual. Analyses will estimate parameters such as rates of recruitment, retention and number of sessions completed. Questionnaires measuring depressive symptoms and quality of life for both the person with dementia and their carer will be completed at baseline, 3 and 6 months. Qualitative interviews will explore acceptability of the intervention, study procedures and experiences of the sessions.
This study received a favourable ethical opinion from the London Camberwell St Giles Research Ethics Committee (16/LO/0540). We will disseminate findings at key conferences, the Alzheimer's Society and University College London websites and local stakeholder events.
ISRCTN75503960; Pre-results.
抑郁症状在痴呆症患者中很常见，会影响生活质量以及认知和功能衰退。目前，对于轻度痴呆症患者心理干预的可接受性和可行性知之甚少，最近的综述指出需要更多证据。因此，开发和评估预防和治疗这些症状的心理干预措施是一项重要的临床和研究重点。本方案描述了一项研究，该研究测试基于手册的行为激活（BA）干预措施对预防和治疗轻度痴呆症患者抑郁症状的可接受性和可行性。本研究的目的是探讨开展一项关于为期八节干预措施临床效果的实用多中心随机对照试验的可行性。早期痴呆症抑郁症状预防与幸福促进干预（IDEA）项目帮助痴呆症患者及其家庭护理人员识别并安排愉快且有意义的活动。
将通过记忆诊所招募60名在过去6个月内被诊断患有任何类型痴呆症的患者。进一步的标准包括简易精神状态检查表得分≥20，以及有一名可协助干预的家庭护理人员。同意参与的参与者将按2:1的比例随机分配至BA组或常规治疗组。分析将估计诸如招募率、留存率和完成的节数等参数。将在基线、3个月和6个月时完成针对痴呆症患者及其护理人员的测量抑郁症状和生活质量的问卷调查。定性访谈将探讨干预措施的可接受性、研究程序以及各节的体验。
本研究获得了伦敦坎伯韦尔圣贾尔斯研究伦理委员会的有利伦理意见（16/LO/0540）。我们将在重要会议、阿尔茨海默病协会和伦敦大学学院网站以及当地利益相关者活动中传播研究结果。
ISRCTN75503960；预结果。
