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

7.项目摘要/摘要 2016年，美国糖尿病协会(ADA)发布了关于心理社会的首份立场声明 关爱糖尿病患者，确定糖尿病自我管理教育和持续支持 (DSME/S)作为对DD的一线干预。然而，没有证据表明DSME/S是合适的 对DD的干预。建议的RCT将比较DSME+ACT1VATE和传统的DSME/S(通常 CARE；UC)在N=484个不同种族(约25%西班牙裔，10%黑人，5%亚洲人)中改善血糖控制， 主要是工作年龄成年人，T1D控制不佳，DD明显。参与者将被招募 来自斯克里普斯糖尿病和内分泌学分部-一家大型临床内分泌诊所，其13 医生会员服务于数以千计的T1D成人。利用现有的和现实世界的进程， 电子健康记录将用于识别符合条件的患者并检查主要结果。全 参与者将收到UC，该UC由注册的Scripps提供的标准1：1 DSME组成 护士/注册糖尿病护理和教育专家(RN/CDCES)。此后，参赛者将获得5 1)T1D支持小组的远程医疗小组会议，传统内容由 RN/CDCES(即，DSME/S的持续支持部分，UC组)，或2)心理 直接设计用于解决DD的干预，由行为健康提供者提供，该提供者是 糖尿病护理团队(ACT1VATE组)的综合成员。灵活的ACT1VATE协议便于 针对(1)参与者导致发育迟缓的根本原因(S)，(2)这一主要工作年龄的发展需求 成人群体；(3)患者群体的不同文化构成，通过敏感地考虑 影响糖尿病自我管理的价值观和思维模式/信念。ACT1VATE接地 接受与承诺疗法(ACT)，已通过简短的形式在临床上有效实施； 通过电话和其他方式实施；适应各种慢性病。然而， 只有两项小型研究检验了这种方法在糖尿病中的应用，而且都没有集中在患有糖尿病或糖尿病的患者身上。 将ACT干预者整合为糖尿病护理团队的成员。我们预测DSME+DSME+ ACT1VATE在改善DD和血糖控制方面优于传统的DSME/S(UC)，因为其(1) 特别关注糖尿病，没有任何期望，与糖尿病相关的困难想法和情绪必须(或 可以完全消除；和(2)有目的地将糖尿病自我护理行为与个人的 根深蒂固的价值观，从而激发有意义和持久的健康行为的内在、以患者为中心的动机 改变。我们假设，作为在管理上取得成功的副产品，DD将减少ACT1VATE 一个人的健康和对难治性糖尿病相关想法和感受的接受度越来越高。

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.