Objective
The objective of this proposal is to test whether the addition of a psychological intervention that directly targets anxiety, depression and diabetes self-management in young adults with type 1 diabetes will yield clinically significant improvements in both emotional wellbeing and glycemic control relative to CGM alone, which has become the current standard of type 1 diabetes care.
Background Rationale
Young adults (YA) with type 1 diabetes (T1D) have high levels of anxiety and depression and some of the highest HbA1c levels among all age groups with T1D. Nevertheless, few rigorous trials have specifically targeted anxiety and depressive disorders in YA with T1D. It remains unknown whether such interventions can positively impact glycemic outcomes in YA with T1D, limiting availability of effective care for this vulnerable population. The YA period is unique, with psychological issues emerging most often during this developmental stage. In addition, increasing independence in diabetes self-management tasks and transitioning from pediatric to adult healthcare add significant burden for YA with T1D. Thus, a successful intervention approach to address anxiety and depression in YA with T1D should be adapted to the unique stressors they face and be aligned with their developmental stage and preferences. Thirty-five years of behavioral science research has established that anxiety and depression are common in diabetes, are associated with problematic diabetes self-management, and predict negative health outcomes. Although various interventions for depression in adults T1D or type 2 diabetes have been developed and generally show positive effects on both depression and glycemic control, few trials are available that target anxiety, despite its greater or equivalent prevalence to depression. Typically, trials exclude patients who experience comorbidity between anxiety and depression, despite the fact that this comorbidity is very common in clinical practice. Thus, the relevance of disorder-specific approaches (targeting either depression or anxiety, both not both) to clinical care is limited. Although treatment recommendations from the American Diabetes Association emphasize the need for routine screening for anxiety and depression and provision of evidence based treatments as part of comprehensive diabetes care, models for how to implement this in real world settings are lacking. Translation of evidence-based interventions to diabetes care settings is further limited by the mismatch between empirically supported disorder-specific protocols and the clinical realities of psychiatric comorbidity. The Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) provides a promising answer to these challenges by targeting the underlying psychological mechanisms that are shared across various emotional disorders with a single, time-limited protocol. Prior research shows strong evidence for efficacy of UP-CBT in a variety of patient populations for anxiety disorders and comorbid disorders, including depression. However, the UP-CBT has not been previously evaluated in diabetes. Testing the efficacy of the UP-CBT in YA with T1D provides an opportunity to address the needs of a high-risk group of individuals living with diabetes. Integrating continuous glucose monitoring (CGM) review and feedback and adapting the UP-CBT to address problems with self-management that often co-occur with anxiety and depression should maximize the impact of this approach on diabetes health outcomes.
Description of Project
Young adults with type 1 diabetes have increased prevalence of psychiatric conditions as compared to those without diabetes. Most common among these are anxiety and depressive disorders, which often occur together. Young adults with type 1 diabetes also have some of the highest HbA1c levels among all age groups with type 1 diabetes. Anxiety and depression have each been associated with problems with diabetes self-management and glycemic regulation, making young adults with these conditions among the highest risk for poor diabetes health outcomes. This project proposes to use a telemedicine-delivered unified protocol for cognitive behavioral therapy (CBT), enhanced with continuous glucose monitoring (CGM) review, to target anxiety and depression in young adults with type 1 diabetes. The unified protocol for CBT (UP-CBT) was developed to target the common mechanisms underlying a variety of emotional disorders and has previously demonstrated efficacy for multiple disorders, including co-morbid anxiety and depression. However, it has not previously been tested in or adapted for diabetes. The efficacy of UP-CBT for anxiety and depression in young adults with type 1 diabetes will be tested in comparison to CGM only in a randomized controlled trial. Our central hypothesis is that the addition of the UP-CBT which will target the underlying psychological causes of emotional disorders and provide skills and support to enhance diabetes self-management will yield clinically significant improvements in anxiety and depression symptom severity (primary outcomes) and glycemic control (secondary outcome, reflected by CGM-derived time in range) relative to CGM alone. We propose to recruit 94 young adults (age 18-30) with type 1 diabetes from a national population for an entirely virtual 12-month study over three years, with targeted recruitment of racial/ethnic minorities. In addition to use of gold-standard clinical interviews for anxiety and depression, administered by a clinician blinded to treatment condition, and CGM-derived time in range, we will examine other outcomes related to glycemic regulation derived from CGM (e.g., time in hyperglycemia, time in hypoglycemia, variability of blood glucose levels over time) and based on HbA1c data collected over the course of the trial. We will also administer validated patient-reported outcome (PRO) surveys and will collect 'in-the-moment' ratings of emotional well-being, self-care behaviors, and related factors via smartphone-based ecological momentary assessment. These momentary data will be integrated with CGM data to assess day-to-day changes in anxiety, depression, well-being, self-management, and glycemia over the course of the trial. Finally, we will collect information on the costs, feasibility and acceptability of the intervention to inform future efforts at widespread dissemination if the trial demonstrates the efficacy of UP-CBT.
Anticipated Outcome
• Potential new care approach to impact psychosocial and glycemic outcomes in young adults with type 1 diabetes • Answer gap in literature of whether targeting anxiety and depression with a specific psychological intervention improves glycemic outcomes in type 1 diabetes • Testing of new research methodology pairing mobile ecological momentary assessment and continuous glucose monitoring (CGM) to perform intensive longitudinal analysis that provides data on within-person, day-to-day changes in anxiety, depression, affective states, diabetes self-management, and glycemia • Calculation of intervention costs and implementation data for future dissemination plans
Relevance to T1D
This proposal will have major impact across several areas relevant to type 1 diabetes (T1D). We will directly test whether targeting anxiety, depression and self-management in young adults with T1D with a time-limited cognitive behavioral intervention can result in clinically significant improvements, over those achieved with standard of medical care CGM alone. Our design is scientifically rigorous and our results will have a significant impact on our scientific understanding of the relationship between emotional disorders and glycemic levels and variability. Our approach is also translation-focused and aimed at addressing questions of interest to patients and providers. We lay the groundwork for a new therapeutic option for mental health and diabetes providers that can be disseminated widely through various clinical practice settings as a billable service, creating a sustainable model supporting implementation of recent guidelines that recommend routine screening and interventions for anxiety and depression as part of comprehensive diabetes care. Our work will highlight new technologies and analytic approaches to uncover important relationships between emotional states and glycemic control in T1D, which other researchers can use in future diabetes technology, pharmacological, and behavioral trials. We also offer the larger T1D community with the potential for a new clinical approach to improve quality of life and glycemic control in T1D that is scalable, accessible, and sustainable.