Effect of Group Cognitive Behavioral Therapy on Psychological Stress and Blood Glucose in People with Type 2 Diabetes Mellitus: A Community-Based Cluster Randomized Controlled Trial in China

Abstract

Background: Cognitive behavioral therapy (CBT) for psychological disorders in adults with type 2 diabetes mellitus (T2DM) is usually delivered by psychiatrists or researchers. We assessed whether CBT delivered by general practitioners reduced anxiety and depression and improved glycemic levels in adults with T2DM. Methods: We conducted a community-based cluster randomized controlled trial in adults with T2DM from 48 communities in China. Participants received either CBT plus usual care (UC) or UC only. The primary outcomes were depression (Patient Health Questionnaire-9; PHQ-9) and anxiety (General Anxiety Disorder questionnaire; GAD-7). The secondary outcome was glycated hemoglobin concentration. Outcome data were collected from all participants at baseline, two months, six months, and one year. Intention-to-treat analysis was used. Findings: There were 1208 participants. The CBT group showed greater improvement in GAD-7 and PHQ-9 scores, respectively, than the UC group after two months(t = 5.12, P<0.0001; t = 4.45, P<0.0001), six months(t = 4.58, P<0.0001; t = 4.37, P = 0.0001), and one year (t = 3.91, P<0.0001; t = 3.59, P = 0.0003). There was no difference in glycemic levels between the CBT and UC groups at two months, but levels were better in the CBT group at six months and one year (t = 6.83, P<0.0001; t = 4.93, P<0.0001, respectively). Subgroup analysis indicated a long-term effect of CBT only for mild and moderate anxiety and depression groups. Similarly, glycemic level improved only in these groups. All general practitioners had Cognitive First Aid rating scale scores ≥4. No CBT-related adverse events were reported. Interpretation: General practitioners can deliver CBT interventions. CBT plus UC is superior to UC for reducing mild/moderate anxiety and depression, and improves glycemic control in adults with T2DM. Trial Registration: The trial was prospectively registered with the Chinese Clinical Trials Registry (reference: ChiCTR-IOP-16008045) Funding Statement: This research was funded by the Preventive Medicine Research Projects of Jiangsu Province Health Department in 2015 and 2018 (Y2015010,Y2018016), the Science and Technology projects of Xuzhou city in 2015 (KC15SM046), and the Youth Medical Talent Project of “Ke Jiao Qiang Wei Projects” in Jiangsu Province (QNRC2016375). Declaration of Interests: No potential conflicts of interest relevant to this article were reported. Ethics Approval Statement: The present study was conducted under protocols approved by Xuzhou Center for Disease Control and Prevention and the Xuzhou of Medical Sciences Ethics Committee (Approval No. 20151210). Written informed consent was obtained from all participants. The trial was conducted according to the 2000 revised version of the Helsinki Declaration.