认知焦虑敏感性治疗成人轻度认知障碍或痴呆患者焦虑的研究设计和方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-06 DOI:10.1016/j.cct.2025.108044

Abigail E. Markley , Kayley M. Stratton , Grace Y. Cho , Norman B. Schmidt , Julie Suhr , Julia L. Sheffler , Christopher Nguyen , Frederick T. Schubert , Jaime R.G. Quiles , Miracle R. Potter , Melissa A. Meynadasy , Sarah Millisor Irvin , Nicholas P. Allan

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引用次数: 0

摘要

背景：焦虑在患有轻度认知障碍（MCI）和轻度阿尔茨海默病及相关疾病（ADRD）的老年人中普遍存在，并可能导致认知衰退加速和护理伴侣负担增加。计算机化焦虑敏感性治疗（CAST）是一种新的基于cbt的针对焦虑敏感性的干预措施，尚未在该人群中进行广泛测试。方法：这项随机对照试验（NCT05748613）将比较194对MCI/轻度ADRD老年人及其护理伙伴的CAST和健康教育对照（HEC）。主要结局包括焦虑敏感性和焦虑症状的减少。次要结局包括心理健康和幸福症状的测量、认知能力的改善和护理伙伴负担的减轻。参与者将在基线、两次干预期间进行评估，并在干预后1、3和6个月进行随访。预期结果：与HEC相比，CAST干预后显著降低焦虑敏感性（AS），减少焦虑。次要的假设认为，CAST会比HEC更有效地减少其他精神症状和改善认知功能。此外，与HEC相比，CAST将减轻护理伴侣的痛苦并改善他们的生活质量，次要假设表明这些效果将通过老年人AS的减少来调节。此外，从干预前到干预后，AS的减少将解释CAST对焦虑的影响，并且第二个假设表明，内感受性恐惧条件反射的减少也将有助于观察到的焦虑减少。临床试验：政府注册：#NCT05748613。

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Study design and protocol for cognitive anxiety sensitivity treatment for anxiety in adults with mild cognitive impairment or dementia

Background

Anxiety is prevalent among older adults with mild cognitive impairment (MCI) and mild Alzheimer's disease and related disorders (ADRD) and may contribute to accelerated cognitive decline and increased care partner burden. Computerized Anxiety Sensitivity Treatment (CAST) is a novel, CBT-based intervention targeting anxiety sensitivity, which has not been widely tested in this population.

Methods

This randomized controlled trial (NCT05748613) will compare CAST to a health education control (HEC) in 194 dyads consisting of older adults with MCI/mild ADRD and their care partners. Primary outcomes include reductions in anxiety sensitivity and anxiety symptoms. Secondary outcomes include measures of mental health and well-being symptoms, improved cognitive performance, and decreased care partner burden. Participants will be assessed at baseline, during two intervention sessions, and follow-ups at 1-, 3-, and 6-months post-intervention.

Expected outcomes

CAST will significantly lower anxiety sensitivity (AS) post-intervention and reduce anxiety compared to HEC. Secondary hypotheses propose that CAST will reduce other mental symptoms and improve cognitive functioning more effectively than HEC. Additionally, CAST will alleviate care partner distress and improve their quality of life compared to HEC, with the secondary hypothesis suggesting that these effects will be mediated by reductions in AS in older adults. Furthermore, reductions in AS from pre- to post-intervention will account for the effect of CAST on anxiety, and the secondary hypothesis suggesting that reductions in interoceptive fear conditioning will also contribute to the observed anxiety reduction.

Clinicaltrials.gov registration: #NCT05748613.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.