A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial.

OBJECTIVES:Our aim in this study was to determine whether a cognitive-behavioural therapy plus small changes lifestyle intervention can produce comparable improvements in insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. METHODS:This study is a secondary analysis of Collaborative Care Management for Distress and Depression in Rural Diabetes Study, a randomized, controlled trial of a 16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention compared with usual care. Outcomes included glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care. Our investigation provides 2 sets of contrasts: 1) insulin users in the intervention group compared with insulin users in the usual-care group and 2) insulin users compared with noninsulin users in the intervention group only. RESULTS:Of the 139 participants, 72 (52%) were using insulin at baseline and had significantly higher levels of A1C (10.2±2.1% vs 8.9±1.6%) and RRD (3.3±1.4 vs 2.8±1.1), and significantly poorer medication adherence (5.2±2.1 days/wk vs 5.5±1.7 days/wk). Intervention patients using insulin exhibited significantly greater reductions in RRD and marginally significant improvements in medication adherence and A1C compared with insulin users in usual care. Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use. CONCLUSIONS:Tailored cognitive-behavioural therapy with a small-changes lifestyle intervention improved elevated RRD and A1C outcomes at least as effectively in insulin users as non‒insulin users. Future powered studies need to address the role of insulin use in uptake and treatment outcomes.