Szigethy Eva, Solano Francis, Wallace Meredith, Perry Dina L, Morrell Lauren, Scott Kathryn, Bell Megan Jones, Oser Megan
Department of Psychiatry and Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Department of Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
BMJ Open. 2018 Jan 13;8(1):e019108. doi: 10.1136/bmjopen-2017-019108.
Generalised anxiety disorder (GAD) and subclinical GAD are highly prevalent in primary care. Unmanaged anxiety worsens quality of life in patients seen in primary care practices and leads to increased medical utilisation and costs. Programmes that teach patients cognitive-behavioural therapy (CBT) techniques have been shown to improve anxiety and to prevent the evolution of anxiety symptoms to disorders, but access and engagement have hampered integration of CBT into medical settings.
This pragmatic study takes place in University of Pittsburgh Medical Center primary care practices to evaluate a coach-supported mobile cognitive- behavioural programme (Lantern) on anxiety symptoms and quality of life. Clinics were non-randomly assigned to either enhanced treatment as usual or Lantern. All clinics provide electronic screening for anxiety and, within clinics assigned to Lantern, patients meeting a threshold level of mild anxiety (ie, >5 on Generalised Anxiety Disorder 7-Item Questionnaire (GAD-7)) are referred to Lantern. The first study phase is aimed at establishing feasibility, acceptability and effectiveness. The second phase focuses on long-term impact on psychosocial outcomes, healthcare utilisation and clinic/provider adoption/sustainable implementation using a propensity score matched parallel group study design. Primary outcomes are changes in anxiety symptoms (GAD-7) and quality of life (Short-Form Health Survey) between baseline and 6-month follow-ups, comparing control and intervention. Secondary outcomes include provider and patient satisfaction, patient engagement, durability of changes in anxiety symptoms and quality of life over 12 months and the impact of Lantern on healthcare utilisation over 12 months. Patients from control sites will be matched to the patients who use the mobile app.
Ethics and human subject research approval were obtained. A data safety monitoring board is overseeing trial data and ethics. Results will be communicated to participating primary care practices, published and presented at clinical and scientific conferences.
NCT03035019.
广泛性焦虑障碍（GAD）和亚临床广泛性焦虑障碍在初级保健中极为常见。未经治疗的焦虑会使初级保健机构中患者的生活质量恶化，并导致医疗利用率和成本增加。已证明，教授患者认知行为疗法（CBT）技术的项目可改善焦虑状况，并预防焦虑症状演变为疾病，但获取途径和参与度问题阻碍了将CBT纳入医疗环境。
这项实用性研究在匹兹堡大学医学中心的初级保健机构中进行，以评估一项由教练支持的针对焦虑症状和生活质量的移动认知行为项目（Lantern）。诊所被非随机分配至常规强化治疗组或Lantern组。所有诊所均提供焦虑症的电子筛查，在分配至Lantern组的诊所中，达到轻度焦虑阈值水平（即广泛性焦虑障碍7项问卷（GAD-7）得分>5）的患者会被转介至Lantern项目。第一个研究阶段旨在确定可行性、可接受性和有效性。第二阶段使用倾向得分匹配平行组研究设计，重点关注对心理社会结果、医疗保健利用率以及诊所/提供者采用/可持续实施的长期影响。主要结局是比较对照组和干预组在基线和6个月随访之间焦虑症状（GAD-7）和生活质量（简明健康调查）的变化。次要结局包括提供者和患者满意度、患者参与度、焦虑症状和生活质量在12个月内变化的持续性，以及Lantern项目在12个月内对医疗保健利用率的影响。来自对照组的患者将与使用移动应用程序的患者进行匹配。
已获得伦理和人体研究批准。一个数据安全监测委员会正在监督试验数据和伦理情况。研究结果将传达给参与的初级保健机构，并在临床和科学会议上发表和展示。
NCT03035019。
