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.
This research will compare ACT1VATE versus usual care in improving clinical, behavioral, psychosocial, process, and cost outcomes among type 1 diabetes patients with significant diabetes distress and poor glycemic control in a real world, healthcare environment. By positioning the ACT1VATE program within a large, ?real-world? clinical endocrine practice, the researchers will maximize integration with routine medical care for type 1 diabetes and maximize generalizability. The ACT1VATE telemedicine intervention empowers individuals with strategies to manage their diabetes effectively in the context of diabetes distress.
