Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or Regimen-Related Distress Symptoms: 12-Month Outcomes From COMRADE

OBJECTIVE This study evaluated the effect of cognitive behavioral therapy (CBT) plus lifestyle counseling in primary care on hemoglobin A(1c) (HbA(1c)) in rural adult patients with type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. RESEARCH DESIGN AND METHODS This study was a randomized controlled trial of a 16-session severity-tailored CBT plus lifestyle counseling intervention compared with usual care. Outcomes included changes in HbA(1c), RRD, depressive symptoms, self-care behaviors, and medication adherence across 12 months. RESULTS Patients included 139 diverse, rural adults (mean age 52.6 +/- 9.5 years; 72% black; BMI 37.0 +/- 9.0 kg/m(2)) with T2D (mean HbA(1c) 9.6% [81 mmol/mol] +/- 2.0%) and comorbid depressive or distress symptoms. Using intent-to-treat analyses, patients in the intervention experienced marginally significant improvements in HbA(1c) (-0.92 +/- 1.81 vs. -0.31 +/- 2.04; P = 0.06) compared with usual care. However, intervention patients experienced significantly greater improvements in RRD (-1.12 +/- 1.05 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) versus usual care. Improvement in HbA(1c) correlated with improvement in RRD (r = 0.3; P = 0.0001) and adherence (r = -0.23; P = 0.007). CONCLUSIONS Tailored CBT with lifestyle counseling improves behavioral outcomes and may improve HbA(1c) in rural patients with T2D and comorbid depressive and/or RRD symptoms.