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: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10585683
• 关键词: Acceleration; Affective; Alzheimer' s Disease; Alzheimer' s disease related dementia; Anxiety; Behavior Therapy; Cardiac; Caregiver Burden; Caring; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Cohort Studies; Data; Dementia; Development; Diagnostic; Distress; Dropout; Early Onset Alzheimer Disease; Elderly; Emotional; Esthesia; Exercise; Health education; Impaired cognition; Individual; Intervention; Learning; Maintenance; Mediating; Memory; Mental Depression; Meta-Analysis; Motivation; Neurobehavioral Manifestations; Participant; Patients; Persons; Probability; Psychopathology; Quality of life; Randomized; Research; Research Domain Criteria; Research Priority; Risk; Risk Factors; Sampling; Sleeplessness; Social Functioning; Stimulus; Stress; Symptoms; Testing; Translational Research; Treatment Protocols; Treatment outcome; Work; anxiety reduction; anxiety sensitivity; anxiety symptoms; brief intervention; care providers; clinically significant; cognitive ability; cognitive function; conditioned fear; design; efficacy evaluation; experience; follow-up; improved; mild cognitive impairment; mild traumatic brain injury; multimodality; point of care; post intervention; psychoeducation; psychoeducational; randomized, clinical trials; respiratory; response; stressor; trial comparing

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.

焦虑精神病理在轻度认知障碍（MCI）患者中非常普遍，