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

• 批准号: 8596849
• 负责人: GRETCHEN A BRENES
• 金额: $ 31.94万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-05 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8596849
• 关键词: Activities of Daily Living; Adherence; Adult; Age; Anxiety; Anxiety Disorders; Area; Attention; Award; Beck depression inventory; 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; 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

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.

描述（由申请人提供）：由于其高患病率，对老年人焦虑症的研究越来越重要。焦虑与显著的发病率和死亡率相关，突出了开发有效治疗方法的紧迫性。在这份来自新研究者的R 01重新提交的报告中，我们提出了一项精心设计的临床试验，以测试通过电话和工作簿向社区居住的农村老年人提供的晚年GAD的认知行为治疗。该提案建立在PI成功的K奖调查结果的基础上，其中她证明了招募不同老年人的可行性，对治疗的满意度，非常低的流失率（8.3%），以及干预措施在减少焦虑和担忧症状方面的有效性的初步证据。农村地区的老年人往往面临严重的治疗障碍，包括耻辱、交通、缺乏当地受过适当培训的服务提供者以及行动不便。拟议的治疗使用电话和工作簿格式进行，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，这是一个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名年龄≥ 60岁的GAD诊断成人随机分为两组，一组通过电话进行认知行为治疗，另一组通过电话进行非指导性支持治疗。2个主要治疗结局是由HAM-A评估的焦虑症状和由PSWQ-A评估的担忧症状。建议的次要结局是抑郁症状、睡眠、残疾和生活质量。此外，还将检查治疗效果的介导剂和调节剂。中介变量包括过程变量（治疗联盟、依从性、参与者满意度和治疗可信度）和新的精神药物使用;调节变量包括人口统计学信息（年龄、教育、性别、种族、收入）、精神变量（基线焦虑严重程度、基线抑郁障碍、基线精神药物使用）、医疗合并症和治疗师分配。将在6个月内评估缓解维持情况。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，具有广泛传播的高潜力，而且它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要的有效治疗干预措施。