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.

Abstract

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. 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. Patients included 139 diverse, rural adults (mean age 52.6 ± 9.5 years; 72% black; BMI 37.0 ± 9.0 kg/m²) 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; <i>P</i> = 0.06) compared with usual care. However, intervention patients experienced significantly greater improvements in RRD (-1.12 ± 1.05 vs. -0.31 ± 1.22; <i>P</i> = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; <i>P</i> = 0.01), self-care behaviors (1.10 ± 1.30 vs. 0.58 ± 1.45; <i>P</i> = 0.03), and medication adherence (1.00 ± 2.0 vs. 0.17 ± 1.0; <i>P</i> = 0.02) versus usual care. Improvement in HbA_1c correlated with improvement in RRD (<i>r</i> = 0.3; <i>P</i> = 0.0001) and adherence (<i>r</i> = -0.23; <i>P</i> = 0.007). 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.