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临床试验/NCT01259596
NCT01259596已完成不适用

A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
2
主要终点
Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13

研究概览

简要总结

The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive therapy delivered by telephone are effective for reducing worry and anxiety in rural older adults with Generalized Anxiety Disorder (GAD).

详细描述

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 in a workbook format and by telephone, 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. The 2 primary treatment outcomes are anxiety symptoms as assessed by the Hamilton Anxiety Rating Scale, and worry symptoms as assessed by the Penn State Worry Questionnaire-Abbreviated. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 years GAD Reside in rural county Proficient in English

排除标准

  • Current psychotherapy Active alcohol or substance abuse with use within last month Dementia or global cognitive impairment Psychotic symptoms Active suicidal ideation with plan and intent Change in psychotropic medications within last 1 month Significant hearing loss

结局指标

主要结局

Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13

时间窗: baseline to week 13

self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.

Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13

时间窗: baseline to week 13

interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.

次要结局

  • Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks(baseline to week 13)
  • Short Form (36) Health Survey (SF-36) to Week 13(week 13)
  • Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13(baseline to week 13)
  • Pepper Center Tool for Disability (PCT-D)(week 13)
  • Insomnia Severity Index (ISI)(week 13)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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