An RCT of CBT-Telephone for Late-Life GAD

CBT 电话治疗晚年广泛性痴呆症的随机对照试验

基本信息

批准号：
7782455
负责人：
GRETCHEN A BRENES
金额：
$ 45.77万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-02-05 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7782455
关键词：
Activities of Daily Living Adherence Adult Age Anxiety Anxiety Disorders Attention Award Beck depression inventory Behavior Therapy Behavioral Bibliotherapy Client satisfaction Clinical Research Clinical Trials Design Cognitive Cognitive Therapy Communities Comorbidity Depressive disorder Diagnosis Education Elderly Face Gender Generalized Anxiety Disorder High Prevalence Income Intervention K-Series Research Career Programs Location Maintenance Measures Mediator of activation protein Medical Mental Depression Mental disorders Methods Mission Morbidity - disease rate Outcome Participant Patient Self-Report Pharmaceutical Preparations Population Principal Investigator Process Provider Public Health Quality of life Questionnaires Race Randomized Randomized Controlled Trials Recruitment Activity Research Research Personnel Rural SF-36 Services Severities Sleep Sleeplessness Stigmata Supportive care Symptoms Telephone Testing Therapeutic Therapeutic Uses Training Translational Research Transportation Treatment Efficacy Treatment Protocols Treatment outcome Universities Work cost depressive symptoms disability effective therapy functional status improved indexing mortality portability public health relevance response rural area satisfaction secondary outcome social stigma tool treatment effect trial comparing underserved rural area urban area

项目摘要

DESCRIPTION (provided by applicant): Research on anxiety disorders in older adults is of growing importance due to its high prevalence. Anxiety is associated with significant morbidity and mortality, highlighting the urgency to develop effective treatments. In this R01 resubmission from a New Investigator, we propose a carefully designed clinical trial to test a cognitive behavioral treatment for late-life GAD, delivered by telephone and workbook to community-dwelling rural elders. The proposal builds upon the PI's successful K Award findings, in which she demonstrated the feasibility of recruiting diverse older adults, satisfaction with the treatment, very low attrition rates (8.3%), and preliminary evidence of the efficacy of the intervention in reducing symptoms of anxiety and worry. Older adults in rural locations often face significant barriers to treatment, including stigma, transportation, lack of local appropriately trained service providers, and impaired mobility. The proposed treatment is delivered using a telephone and workbook format, which maximizes its portability. Treatment will be compared with nondirective supportive therapy, a very credible comparison condition equivalent to the intervention in therapist attention. We propose to randomize 88 adults = 60 years with a diagnosis of GAD to either cognitive behavioral therapy delivered by telephone, or nondirective supportive therapy delivered by telephone. The 2 primary treatment outcomes are anxiety symptoms as assessed by the HAM-A, and worry symptoms as assessed by the PSWQ- A. The proposed secondary outcomes are depressive symptoms, sleep, disability, and quality of life. Further, mediators and moderators of the treatment effect will also be examined. Mediators include process variables (therapeutic alliance, adherence, participant satisfaction, and treatment credibility) and new psychotropic medication use; moderators include demographic information (age, education, gender, race, income), psychiatric variables (baseline anxiety severity, baseline depressive disorders, baseline psychotropic medication use), medical comorbidity, and therapist assignment. Maintenance of response will be assessed over 6 months. This research has great public health significance, because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs. PUBLIC HEALTH RELEVANCE: Anxiety disorders are associated with significant morbidity and mortality among older adults, highlighting the urgency to develop effective treatments. This project proposes to treat Generalized Anxiety Disorder in underserved rural older adults by reducing barriers associated with treatment. This research has great public health significance because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs.

描述（由申请人提供）：由于老年人焦虑症的高患病率，其研究变得越来越重要。焦虑与显着的发病率和死亡率相关，凸显了开发有效治疗方法的紧迫性。在新研究者重新提交的 R01 中，我们提出了一项精心设计的临床试验，以测试针对晚年广泛性焦虑症的认知行为疗法，该试验通过电话和工作簿向居住在社区的农村老年人提供。该提案以 PI 成功的 K 奖研究结果为基础，其中她证明了招募不同老年人的可行性、对治疗的满意度、极低的流失率 (8.3%) 以及干预措施在减少老年人症状方面的有效性的初步证据。焦虑和担忧。农村地区的老年人在治疗方面常常面临重大障碍，包括耻辱、交通、缺乏当地经过适当培训的服务提供者以及行动不便。所提出的治疗方法是通过电话和工作簿格式提供的，从而最大限度地提高了其便携性。治疗将与非指导性支持治疗进行比较，这是一种非常可信的比较条件，相当于治疗师注意力的干预。我们建议将 88 名 60 岁诊断为广泛性焦虑症的成年人随机分组，接受通过电话提供的认知行为治疗或通过电话提供的非指导性支持治疗。 2 个主要治疗结果是由 HAM-A 评估的焦虑症状和由 PSWQ-A 评估的担忧症状。建议的次要治疗结果是抑郁症状、睡眠、残疾和生活质量。此外，还将检查治疗效果的中介因素和调节因素。中介因素包括过程变量（治疗联盟、依从性、参与者满意度和治疗可信度）和新精神药物的使用；调节因素包括人口统计信息（年龄、教育、性别、种族、收入）、精神变量（基线焦虑严重程度、基线抑郁症、基线精神药物使用）、医疗合并症和治疗师分配。将在 6 个月内评估反应的维持情况。这项研究具有重大的公共卫生意义，因为它是一种低成本的干预措施，具有广泛传播的潜力，并且针对的是服务不足的群体——居住在社区的农村老年人——他们目前缺乏针对其需求的有效治疗干预措施。公共卫生相关性：焦虑症与老年人的显着发病率和死亡率相关，凸显了开发有效治疗方法的紧迫性。该项目建议通过减少与治疗相关的障碍来治疗服务不足的农村老年人的广泛性焦虑症。这项研究具有重大的公共卫生意义，因为它是一种低成本的干预措施，具有广泛传播的潜力，并且针对的是服务不足的群体——居住在社区的农村老年人——他们目前缺乏针对其需求的有效治疗干预措施。