The Diabetes Tune-Up Group: A Multidisciplinary Approach to Improve Diabetes Distress and A1C Among Adults With Type 1 and Type 2 Diabetes.

PURPOSE: The purpose of this study was to assess the feasibility of delivering the Diabetes Tune-Up Group (DTU), a cognitive-behavioral-therapy-based (CBT) multidisciplinary intervention for adults with diabetes distress and elevated A1C using a group in-person delivery format. METHODS: The DTU intervention consisted of 6 weekly group sessions (90 minutes in duration per session). The groups were cofacilitated by a diabetes care and education specialist (DCES) and a master's-level clinical psychology trainee. The intervention integrated CBT with patient-centered diabetes education. Using a pre/post study design, participants completed assessments at baseline, post-intervention, and 3 months following the intervention. RESULTS: The sample consisted of 29 adults with type 1 diabetes (N = 8) or type 2 diabetes (N = 21) who were predominantly female (79%), White (59%), and educated (56% with a college degree or greater). Participants attended 131 total sessions out of 174 possible sessions, for an overall attendance rate of 75.3%. At 3-month follow-up, significant improvements were observed in A1C values (mean decrease = 0.39%). Diabetes distress improved significantly from baseline (mean = 3.44, SD = 0.68) to post-intervention (mean = 2.94, SD = 0.68), and 3-month follow-up (mean = 2.55, SD = 0.75). Significant improvements were also observed in diabetes self-efficacy from baseline to post-intervention and at 3-month follow-up. CONCLUSIONS: This group-based, multidisciplinary intervention resulted in improvements in A1C, diabetes distress, and patient self-efficacy in caring for diabetes. Future studies to validate this intervention approach across settings and delivery platforms are needed.

Emotional Correlates of the COVID-19 Pandemic in Individuals With and Without Diabetes.

OBJECTIVE: To compare the mental health experiences associated with coronavirus disease 2019 (COVID-19) in adults with and without diabetes. RESEARCH DESIGN AND METHODS: Between 29 May 2020 and 30 June 2020, 2,176 U.S. adults completed an online survey including demographics, COVID-19 experiences, depression (eight-item Patient Health Questionnaire) and anxiety (seven-item Generalized Anxiety Disorder) symptoms, perceived stress (10-item Perceived Stress Scale), resilience (Brief Resilience Scale), and diabetes-related distress (in participants with diabetes) (17-item Diabetes Distress Scale). RESULTS: Mean age was 49.6 years (SD 16.9); participants were primarily women (80.0%) and White (88.3%), with an annual household income of ≥$60,000 (57.6%). One hundred reported a diagnosis of type 1 diabetes (4.6%), 304 type 2 diabetes (13.9%), and 145 prediabetes (6.6%). Nearly one-third (29.7%) indicated decreases in income attributable to the pandemic. Participants with type 1 diabetes had higher levels of diabetes distress than participants with type 2 diabetes (P < 0.05), with moderate severity in both groups. Participants with type 2 diabetes had significantly more comorbidities and COVID-19 risk factors than all other groups (all P < 0.01). After controlling for covariates, participants with type 2 diabetes reported significantly more depressive symptoms than those without diabetes (P < 0.05) and lower levels of resilience (P < 0.05). Subgroup analyses by sex and age indicated that women and younger adults, particularly those age 18-34 years, reported significantly more depression and anxiety symptoms, stress, and diabetes-related distress and lower levels of resilience than men and adults age ≥51 years. CONCLUSIONS: In this naturalistic observational study, participants with type 2 diabetes reported more depression, lower resilience, and significantly more COVID-19 risk factors and medical comorbidities than participants without diabetes. Overall, our participants demonstrated worse depression and anxiety symptoms during compared with before the pandemic.

Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes.

BACKGROUND: Participant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states. METHODS: Quantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff. RESULTS: Contact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment. CONCLUSIONS: Recruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03371940 . Registered on 13 December 2017.