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临床试验/NCT05380115
NCT05380115撤回不适用

Implementation of Cognitive-behavioral Therapy for Older Adults With Generalized Anxiety Disorder

Wake Forest University Health Sciences0 个研究点开始时间: 2024年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Feasibility-Number of participants who complete at least 75% of sessions

研究概览

简要总结

The purpose of this research study is to assess the acceptability and feasibility of the implementation strategy and fidelity of cognitive-behavioral therapy (CBT) for older adults with Generalized Anxiety Disorder.

详细描述

All participants will receive CBT. Each subject will be given a workbook and each chapter in the workbook provides information about a different coping strategy for managing worry and anxiety. There will be a daily assignment in the workbook to complete before a call with the personal study coach. For 10 weeks, participants will have a 45-50 minute session (telephone or video) each week with their study coach. These calls will be confidential. The participant and the personal study coach will review the assigned chapter and completed homework during the weekly telephone sessions. Participants will also fill out questionnaires before starting sessions, when completing all 10 sessions, and 6 months after completing sessions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • participants who have had an outpatient visit to an Atrium provider
  • at least one of the following: any diagnosis of an anxiety or depressive disorder; anxiety, depression, or sleep disturbance as a symptom in the problem list or in the note; and use of anxiolytic, anti-depressant, and sleep aide medications.

排除标准

  • diagnosis of dementia or cognitive impairment in the problem list

结局指标

主要结局

Feasibility-Number of participants who complete at least 75% of sessions

时间窗: Week 11

Penn State Worry Questionnaire-Abbreviated (PSWQ-A)

时间窗: week 11

8-item measure of frequency/intensity of worry; most commonly used worry measure. Scores can range from 8 to 40; higher scores indicate higher levels of worry.

Feasibility-Expectancy Rating Scale

时间窗: Week 1

Assesses beliefs in how logical the treatment received seems, confidence in undergoing treatment/recommending to others, and expectations for success. Used in anxiety treatment studies with older adults. Scores can range from 4 to 40; higher scores indicate more positive expectations.

Generalized Anxiety Disorder scale (GAD-7)

时间窗: Week 11

Self-report measure of GAD symptoms. Total scores can range from 0 to 21; higher scores indicate more GAD symptoms.

Feasibility-Intervention adherence

时间窗: Week 11

The percentage of completed sessions

次要结局

  • Patient-Reported Outcomes Measurement Information System (PROMIS)(baseline, week 6, week 11)
  • Generalized Anxiety Disorder scale (GAD-7)(Week 6)
  • Insomnia Sleep Index(baseline, week 6, week 11)
  • Feasibility-Client Satisfaction Questionnaire(Week 11)
  • Feasibility-Working Alliance Inventory, Client(Week 11)
  • Feasibility-Working Alliance Inventory, Therapist(Week 11)
  • Penn State Worry Questionnaire-Abbreviated (PSWQ-A)(week 6)

研究者

申办方类型
Other
责任方
Sponsor

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