ACT1VATE: Addressing Emotional Distress to Improve Outcomes among Diverse Adults with Type 1 Diabetes

7.项目概要/摘要 2016年，美国糖尿病协会（ADA）发布了其关于心理社会问题的就职立场声明。 护理糖尿病患者，确定糖尿病自我管理教育和持续支持 (DSME/S）作为DD的一线干预措施。然而，没有证据表明DSME/S是适当的 干预DD。拟定的RCT将比较DSME + ACT 1VATE与传统DSME/S（口服） 护理; UC）在N=484例不同人群（约25%西班牙裔，10%黑人，5%亚裔）中改善血糖控制， 主要是工作年龄的成年人，控制不佳的T1 D和显著的DD。参与者将被招募 来自斯克里普斯糖尿病和内分泌科-一个大型的临床内分泌实践， 医生成员为成千上万的T1 D成年人提供服务。利用现有的和真实的世界进程， 电子健康记录将用于确定符合条件的患者并检查主要结果。所有 参加者将获得UC，其中包括标准的，1：1 DSME由斯克里普斯注册 注册糖尿病护理和教育专家（RN/CDCES）。此后，与会者将获得5 1）T1 D支持小组的远程医疗小组会议，传统内容由 RN/CDCES（即，DSME/S的持续支持组件“S”; UC组），或2）心理 干预，直接设计用于解决DD，由行为健康提供者提供， 糖尿病护理团队（ACT 1VATE组）的综合成员。灵活的ACT 1VATE协议有助于 根据（1）参与者DD的根本原因，（2）这一主要工作年龄段的发展需求进行定制 成人组;和（3）患者人群的不同文化组成，通过敏感的考虑， 影响糖尿病自我管理的价值观和思维模式/信念。ACT 1VATE接地 接受和承诺疗法，通过简短的形式在诊所有效地提供; 通过电话和其他方式实施;并适用于广泛的慢性病。然而，在这方面， 只有两项小型研究在糖尿病中检查了这种方法，并且都没有关注DD患者， 将ACT干预者纳入糖尿病护理团队。我们预测DSME + DSME + ACT 1VATE在改善DD和血糖控制方面上级传统DSME/S（UC），因为其（1） 特别关注DD，不期望与糖尿病相关的困难思想和情绪必须（或 可以）完全消除;和（2）糖尿病自我护理行为与个人的 根深蒂固的价值观，从而引发内在的，以病人为中心的动机，有意义的和持久的健康行为 变化我们认为，作为成功管理的副产品，ACT 1VATE中的DD将减少 一个人的健康和增加接受困难的糖尿病相关的思想和感情。

7. Project Summary/Abstract In 2016, the American Diabetes Association (ADA) released its inaugural Position Statement on Psychosocial Care for People with Diabetes, which identified diabetes self-management education and ongoing support (DSME/S) as the first-line intervention for DD. However, there is no evidence that DSME/S is the appropriate intervention for DD. The proposed RCT will compare DSME + ACT1VATE versus traditional DSME/S (Usual Care; UC) in improving glycemic control among N=484 diverse (~25% Hispanic, 10% Black, 5% Asian), predominantly working age adults with poorly controlled T1D and significant DD. Participants will be recruited from the Scripps Division of Diabetes and Endocrinology – a large clinical endocrine practice whose 13 physician members serve thousands of T1D adults. Capitalizing on existing and real world processes, electronic health records will be used to identify eligible patients and examine primary outcomes. All participants will receive UC, which consists of standard, 1:1 DSME delivered by a Scripps Registered Nurse/Certified Diabetes Care and Education Specialist (RN/CDCES). Thereafter, participants will receive 5 telemedicine group sessions of either 1) T1D support groups with traditional content delivered by an RN/CDCES (i.e., the ongoing support component, “S,” of DSME/S; UC group), or 2) a psychological intervention, directly designed to address DD, to be delivered by a Behavioral Health Provider who is an integrated member of the diabetes care team (ACT1VATE group). The flexible ACT1VATE protocol facilitates tailoring to the (1) participants’ root cause(s) of DD, (2) developmental needs of this predominantly working age adult group; and (3) diverse cultural composition of the patient population, via the sensitive consideration of values and thought patterns/beliefs that influence diabetes self-management. ACT1VATE is grounded in Acceptance and Commitment Therapy (ACT), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. However, only two small studies have examined this approach in diabetes, and neither focused on individuals with DD or integrated the ACT interventionist as a member of the diabetes care team. We predict that DSME + DSME + ACT1VATE will be superior to traditional DSME/S (UC) in improving DD and glycemic control given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual’s deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. We posit that DD will decrease in ACT1VATE as a by-product of achieving success in managing one’s health and increasing acceptance of difficult diabetes related-thoughts and feelings.