Cognitive Behavioral Intervention Produces Comparable Reductions in Regimen-Related Distress in Insulin Users and Nonusers—Twelve-Month Results from COMRADE

Complex treatment and monitoring behaviors that accompany insulin use can be associated with higher levels of regimen-related distress (RRD), poor glycemic control, and lower medication adherence. Whether cognitive behavioral intervention can provide comparable impact on distress levels in insulin-using and non-insulin using patients is poorly described. COMRADE was a prospective randomized controlled trial that evaluated the effectiveness of a 16-session severity tailored cognitive behavioral intervention plus lifestyle change counseling (n = 67; IG=intervention group) delivered by trained staff compared to usual care (n = 72; CG=control group), in 139 rural adult patients (mean age = 52.6 ± 9.5 years.; 72% black; BMI = 37.0 ± 9.0) with uncontrolled (mean A1c = 9.6 ± 2.0) type 2 diabetes and co-morbid depressive (PHQ-2) or distress (DDS-2) symptoms at screening in an academic primary care clinic. At baseline and at 12-month follow-up: A1c, RRD (sub-score of DDS-17), self-care behaviors (SDSCA), and medication adherence (ModMAS) were measured using validated instruments. This analysis specifically examined changes in RRD in insulin users (n = 41, 61%) vs. oral medications and lifestyle change users (n = 26, 39%) in the intervention arm only. While A1c was higher in insulin users at baseline as expected, there were no other significant differences between insulin-users and non-users at baseline. Cognitive behavioral intervention produced comparable improvement in RRD (-1.1 ± 1.1 vs. -1.0 ± 0.9; p = 0.6), self-care behaviors (+1.0 ± 1.3 vs. +1.3 ± 1.3; p = 0.4) and medication adherence (+1.0 ± 1.9 vs. +1.0 ± 2.2; p = 0.9) in insulin users vs. non-users. Insulin users had a greater reduction in A1c (-1.1 ± 1.9 vs. -0.6 ± 1.5; p = 0.3). Tailored cognitive behavioral intervention produces comparable improvements in RRD, self-care behaviors, medication adherence and A1c in insulin users and non-users.