Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes with Comorbid Depressive and/or Distress Symptoms—Twelve-Month Outcomes from COMRADE

Patients with type 2 diabetes (T2D) and co-morbid depressive and/or distress symptoms have poor glycemic control and worse health outcomes. This prospective randomized controlled trial 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 HbA1c = 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: height, weight, BP, A1c, diabetes distress (DDS-17), depressive symptoms (PHQ-9), self-care behaviors (SDSCA), empowerment (DES), and medication adherence (ModMAS) were measured using validated instruments. There were no differences between groups at baseline. Between group (IG vs. CG) differences at 12-months follow-up were significant for changes from baseline in diabetes-related distress (-0.83 ± 0.88 vs. -0.15 ± 0.92; p = 0.001), regimen-related distress (-1.12 ± 1.vs. -0.31 ± 1.22; p = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; p = 0.01), self-care behaviors (+1.10 ± 1.30 vs. +0.58 ± 1.45; p = 0.03), and medication adherence (+1.00 ± 2.0 vs. +0.17 ± 1.0; p = 0.02). Differences in change in A1c (-0.92 ± 1.81 vs. -0.31 ± 2.04; p = 0.06) were substantially greater in the intervention group and achieved borderline significance. There were no significant differences in glycemic response patterns by race or gender. A tailored cognitive behavioral intervention significantly improves behavioral outcomes and glycemic control in rural black and white patients with T2D and co-morbid depressive and/or distress symptoms.