Objective
The primary objective of this research is to test a novel treatment for EDs in T1D (iACT), optimized for delivery in routine health care setting. iACT is an mHealth intervention for eating disorders in type 1 diabetes mellitus (ED-T1DM) based on Acceptance and Commitment Therapy (Merwin et al., 2021). This treatment was piloted in a small trial of ED-T1DM patients and showed good outcomes. This study adapts the intervention for maximum portability and conducts a stringent test of its efficacy by comparing it to a Waitlist Control (i.e. individuals not receiving the treatment). A secondary objective of this study is to examine whether continuous glucose monitoring can be used to detect EDs earlier, when it is easier to intervene. We do this by examining whether there are glycemic patterns reliably associated with EDs in T1DM.
Background Rationale
EDs in T1DM are associated with early and severe diabetes-related medical complications and a 3-fold increase in risk of premature death. Existing treatments for EDs are less effective for individuals with T1D because they are not tailored to the unique experiences of living with diabetes and special circumstances in which ED behaviors develop or are maintained. Our previous studies of ED-T1DM have identified psychological experiences and events that are associated with EDs or increase the risk of ED behaviors occurring in real time, such as momentary increases in anxiety or guilt/shame prior to eating. We used this information to develop a model of EDs in T1DM and a novel treatment, iACT. iACT was grounded in Acceptance and Commitment Therapy (ACT), a newer cognitive-behavioral therapy (CBT) that may be well-suited to chronic health conditions like T1D because it emphasizes approaching situations that are emotionally upsetting in order to pursue personal values or goals. iACT combined more typical face-to-face sessions with interventions delivered by mobile phone to help individuals develop skills more quickly and apply these skills at home at times of emotional distress, and when they were making decisions about their eating or diabetes management. In the current project, we work with patients and practitioners to determine the best strategy to deliver the intervention with the least burden to patients and greatest likelihood of successful adoption and implementation diverse health care settings. We then randomize individuals with T1DM-ED to either iACT or the Waitlist control and compare the outcomes of the groups. We also examine processes by which change occurs which might help us improve the treatment (make it more efficient or effective) or learn more about how these problems develop or are maintained. Participants in the Waitlist group are given access to the treatment after the study ends. ED treatment in T1DM has been slowed by a lack of intervention, but also difficulties detecting EDs, which may be shrouded by guilt, secrecy or shame. Thus, the current study also examines whether these problems can be identified by continuous glucose monitoring, which may help practitioners engage pts in treatment when it is easier to intervene.
Description of Project
Eating disorders (EDs) in T1DM are associated with early and severe diabetes-related medical complications and premature death. Existing treatments for EDs are less helpful for individuals with T1DM, potentially because they are not tailored to the unique experiences of living diabetes, or the special circumstances in which EDs develop or are maintained. "iACT” is a novel treatment that we developed specifically for EDs in T1DM based on our previous research. The intervention is grounded in Acceptance and Commitment Therapy (ACT), a newer CBT that has been found to be helpful for a lot of people and may be particularly well-suited for chronic illnesses, such as T1DM. iACT is also novel in that it is an mHealth intervention that includes both face-to-face interactions and interventions delivered by mobile phone. These interventions help individuals identify triggers for EDs in-the-moment and cope more effectively using ACT-based skills. We piloted iACT in a small clinical trial with 23 individuals with ED-T1DM. Most participants had bulimia nervosa. Overall, iACT was highly acceptable. The vast majority of participants who started treatment completed it. iACT was also associated with large improvements in ED behavior, diabetes management and diabetes distress. Many individuals also improved their HbA1c. However, this was a small study and there was no comparison group, thus it is unclear whether change was attributable to the intervention, and what amount of change might have occurred with time alone. In the current study, we test this intervention with a larger sample of individuals with ED-T1DM, and compare their outcomes to a group of individuals with ED-T1DM not receiving the treatment. Assessments are taken at baseline, and 6, 12, 24 and 36 weeks (corresponding with baseline, mid-treatment, end-of-treatment, and 3- and 6-months post-treatment). Waitlist participants are offered the treatment after they complete their final assessment. Our primary outcome is glycemic control, assessed with continuous glucose monitoring (CGM) and includes variables such as time spent in range, and frequency of Level 1 and Level 2 hypo- and hyperglycemia and blood glucose (BG) variability. We also look at episodes of diabetic ketoacidosis and HbA1c. Other outcomes of interest are ED symptoms (assessed with a diagnostic interview, questionnaires and daily reports made by mobile phone) and diabetes distress. In addition to testing treatment outcomes, we also examine the process by which symptoms improve (what changes when and how this is associated with outcomes), and identify factors that might influence how people respond to the treatment. Finally, EDs can be difficult to detect for a variety of reasons, leading to treatment delays. Thus, the current study also examines whether there are particular glucose patterns in CGM data that indicate the presence or type of ED to help health care providers identify these problems earlier when it is easier to intervene. The overarching goal of this project is to establish an effective treatment for EDs in T1DM to reduce suffering and preserve the longevity and quality of people’s lives.
Anticipated Outcome
This project will determine how best to implement iACT and its effectiveness in relieving EDs in T1DM. The project will also provide information about how the treatment works and for whom, which could help refine the intervention or inform treatment matching; and information about how to detect EDs with CGM, which could be helpful in identifying individuals in need. It is anticipated that iACT will result in superior improvements in glycemic control, ED symptoms, diabetes management, and diabetes distress, relative to a Waitlist control. It is expected that the treatment will work by increasing psychological flexibility –or the ability to self-regulate emotional and behavioral responses (inhibiting avoidance/escape behaviors in order to engage in effective, value and goal-directed behavior), which may be facilitated by early changes in glycemic control.
Relevance to T1D
EDs affect a significant number of individuals with T1DM. If successful, this project will establish an empirically-supported treatment for EDs in T1DM, which are sorely needed. It will also advance knowledge of how to implement the intervention in health care settings with minimum burden and maximum impact, and increase ED detection, which could greatly reduce the duration of untreated illness and improve prognosis. The project may also advance scientific knowledge of the dynamic interplay between blood glucose and self-regulation, which could have implications for the prevention or treatment of other emotional and behavioral disorders in T1DM.