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Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care Providers

Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care Providers
针对轻度认知障碍/轻度阿尔茨海默病及其护理人员的简短焦虑干预的随机临床试验
批准号:
10585683
负责人:
Nicholas Paul Allan
金额:
$76.45万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-01-01 至 2027-12-31

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项目成果

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中文摘要
翻译
焦虑精神病理学在轻度认知障碍(MCI)患者中非常普遍, 阿尔茨海默病和相关痴呆症(ADRD)及其护理伙伴。最近的Meta- 分析表明,在大约40%的患有焦虑症的人中, ADRD和大约25%的护理伙伴,以及焦虑率增加, MCI患者的临床样本。此外,最近的一项研究表明, 是一个标志物,并可能有助于早期发病的ADRD症状,其中 MCI。尽管如此,对于MCI/ADRD或其患者的焦虑, 关怀伙伴此外,焦虑症的先前治疗方案是冗长的,过度依赖 完整的记忆和认知能力,并导致高辍学率。简要,侧重机制 干预提供了一种有效的替代方法来处理焦虑的人, MCI/ADRD及其护理伙伴。焦虑敏感性(AS)是一种经过充分研究的风险 与焦虑和其他形式的焦虑的发生和维持有关的机制 精神病理学AS作为一个广泛的压力放大因素,因为它加剧了经验 身体和情感的感觉,导致增加的痛苦。因此,个人与 AS升高的人更有可能对各种各样的压力源做出夸张的反应 包括认知症状(例如,注意力和记忆力问题)。幸运的是,专注 已经开发的干预措施表明AS可以快速有效地减少。 这些干预措施包括心理教育,但重点是内感受性暴露(IE) 旨在将条件性恐惧减少到引起焦虑的内部刺激的练习。酯临床 试验,证据表明,这种干预措施可以显着减少AS,这些减少 减轻焦虑症状。虽然AS干预已成功用于 各种各样的样本,他们还没有被测试的人与MCI/ADRD。我们建议 进行一项完全有效的随机临床试验(RCT),以测试一种简短的、基于CBT的干预措施, 这被称为认知焦虑敏感性治疗(CAST),用于MCI/轻度AD患者。我们 我相信CAST的IE成分与MCI/轻度ADRD特别相关, 可能会因为认知能力下降而受损此外,我们的初步数据表明,CAST 在MCI老年人中产生中等至高的AS和焦虑降低效应量。二合体 由MCI/轻度AD及其护理伴侣组成的受试者将随机分配至CAST组, 教育控制(HEC)条件(N = 197),并随访6个月,以评估 焦虑和痛苦,认知功能和生活质量。
英文摘要
Anxiety psychopathology is highly prevalent in people living with mild cognitive impairment (MCI), Alzheimer's disease and related dementias (ADRD) and their care partners. Recent meta- analyses suggest clinically significant anxiety symptoms in approximately 40% of those with ADRD and approximately 25% in their care partners, as well as increased rates of anxiety in clinical samples of patients with MCI. Moreover, a recent review suggests that elevated anxiety is a marker for and potentially contributes to earlier onset of ADRD symptoms among those with MCI. Despite this, there are no well-established interventions for anxiety in MCI/ADRD or their care partners. Moreover, prior treatment protocols for anxiety are lengthy, excessively rely on intact memory and cognitive abilities, and result in high dropout rates. Brief, mechanism focused interventions offer an efficient, alternative approach to dealing with anxiety in people with MCI/ADRD and their care partners. Anxiety sensitivity (AS) is an extremely well-researched risk mechanism relevant to the genesis and maintenance of anxiety and other forms of psychopathology. AS acts as a broad stress amplification factor as it exacerbates the experience of somatic and emotional sensations, leading to increased distress. As such, individuals with elevated AS are more likely to experience exaggerated responses to a wide array of stressors including cognitive symptoms (e.g., concentration and memory problems). Fortunately, focused interventions have been developed showing that AS can be quickly and effectively reduced. These interventions include psychoeducation but focus heavily on interoceptive exposure (IE) exercises designed to reduce conditioned fear to anxiety-provoking internal stimuli. Across clinical trials, evidence shows such interventions can markedly reduce AS and that these reductions mediate reductions in anxiety symptoms. While AS interventions have been successfully used in a variety of samples, they have not been tested for people with MCI/ADRD. We propose to conduct a fully powered randomized clinical trial (RCT) to test a brief, CBT-based intervention, called cognitive anxiety sensitivity treatment (CAST) for people with MCI/mild AD. We believe the IE component of CAST will be particularly relevant to MCI/mild ADRD where learning may be compromised due to cognitive decline. Moreover, our preliminary data suggest that CAST yields medium to high effect size reductions in AS and anxiety in older adults with MCI. Dyads consisting of MCI/mild AD and their care partners will be randomized to CAST to a Health Education Control (HEC) condition (N = 197) and followed for six months to evaluate change in anxiety and distress, cognitive functioning and quality of life.
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Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
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