RCT of Tailored Cognitive Behavioral Intervention Reduces Regimen-Related Distress—Relationship to Change in Medication Adherence and Glycemic Control at 12-Month Follow-Up

Elevated regimen related distress (RRD) in type 2 diabetes (T2D) is associated with poor glycemic control and lower medication adherence but the strategy for and impact of reducing RRD in primary care is unclear. Data for this study comes from 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) T2D (52% on insulin) 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, regimen-related distress (sub-score of DDS-17), depressive symptoms (PHQ-9), self-care behaviors (SDSCA), and medication adherence (ModMAS) were measured using validated instruments. There were no differences between groups at baseline in mean age, race, gender, or mean values for A1c, body mass index (BMI), PHQ-9, or RRD scores. At 12-month follow-up patients in the behavioral intervention group had significantly greater reduction in RRD scores than those in the control arm (-1.12 ± 1.vs. -0.31 ± 1.22; p = 0.001). Among intervention group patients only, those with an improvement in RRD score of ≥ 1 (n = 32) had substantially greater improvement in A1c [-1.3 ± 1.7 vs. -0.56 ± 1.9; p = 0.09] and self-care behaviors [+1.33 ± 1.38 vs. + 0.88 ± 1.2; p = 0.16] as well as significantly greater improvement in medication adherence [+1.6 ± 1.7 vs. +0.47 ± 2.2; p = 0.02]. A tailored cognitive behavioral intervention reduces RRD in patients with uncontrolled T2D and co-morbid behavioral problems and is associated with improved medication adherence that may be associated with improved glycemic control. Disclosure L. Lutes: None. D.M. Cummings: None. B. Hambidge: None. M. Carraway: None. S. Patil: None. A. Adams: None. C. Solar: None. K. Littlewood: None. S. Edwards: None. P. Gatlin: None.