School of Psychology, Université Laval, 2325 rue des Bibliothèques, Quebec City, Quebec, G1V 0A6, Canada.
Centre d'Excellence sur le Vieillissement de Québec, Quebec City, Canada.
BMC Geriatr. 2021 May 22;21(1):324. doi: 10.1186/s12877-021-02221-x.
Only a small proportion of older patients with generalized anxiety disorder (GAD) seek professional help. Difficulties in accessing treatment may contribute to this problem. Guided self-help based on the principles of cognitive-behavioral therapy (GSH-CBT) is one way of promoting access to psychological treatment. Moreover, because the therapist's role in GSH-CBT is limited to supporting the patient, this role could be assumed by trained and supervised lay providers (LPs) instead of licensed providers. The main goal of this study is to evaluate the efficacy of GSH-CBT guided by LPs for primary threshold or subthreshold GAD in older adults.
We will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LPs (n = 45) to a wait-list control group (n = 45). Treatment will last 15 weeks and will be based on a participant's manual. Weekly telephone sessions with LPs (30 min maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. Primary outcomes will be the tendency to worry and severity of GAD symptoms. Secondary outcomes will be anxiety symptoms, sleep difficulties, functional deficit, diagnosis of GAD, and cognitive difficulties. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the primary outcomes.
This project will provide evidence on the efficacy of a novel approach to treat GAD in older adults. If effective, it could be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce.
The trial was registered at ClinicalTrials.gov, number NCT03768544 , on December 7, 2018.
只有一小部分患有广泛性焦虑症（GAD）的老年患者寻求专业帮助。获得治疗的困难可能是造成这种情况的原因之一。基于认知行为疗法（CBT）原则的指导性自助治疗（GSH-CBT）是促进获得心理治疗的一种方式。此外，由于 GSH-CBT 中治疗师的角色仅限于支持患者，因此这个角色可以由经过培训和监督的非专业人员（LPs）来担任，而不是由持照人员来担任。本研究的主要目标是评估由 LPs 指导的 GSH-CBT 对老年人原发性或亚阈值 GAD 的疗效。
我们将进行一项多地点随机对照试验，比较由 LPs 指导的实验组（n=45）和等待名单对照组（n=45）。治疗将持续 15 周，基于参与者的手册进行。LP 每周进行一次电话会议（最长 30 分钟），仅提供支持。数据将通过临床医生评估和自我评估问卷获得。主要结果将是担忧倾向和 GAD 症状严重程度。次要结果将是焦虑症状、睡眠困难、功能缺陷、GAD 诊断和认知困难。对于实验组，测量将在治疗前和治疗后以及治疗后 6 个月和 12 个月进行。对于对照组，计划进行三次评估：两次治疗前评估（等待期前后）和接受治疗后评估（治疗后）。通过比较两组主要结局的变化来确定 GSH-CBT 的疗效。
该项目将提供治疗老年 GAD 的新方法的疗效证据。如果有效，它可以在更大的范围内实施，并通过扩大劳动力为许多老年人提供急需的心理健康治疗。
该试验于 2018 年 12 月 7 日在 ClinicalTrials.gov 注册，编号为 NCT03768544。
