Effectiveness of cognitive behavior therapy for sleep disturbance and glycemic control in persons with type 2 diabetes mellitus: A community-based randomized controlled trial in China

Abstract

BACKGROUND Poor sleep quality is a common clinical feature in patients with type 2 diabetes mellitus (T2DM), and often negatively related with glycemic control. Cognitive behavioral therapy (CBT) may improve sleep quality and reduce blood sugar levels in patients with T2DM. However, it is not entirely clear whether CBT delivered by general practitioners is effective for poor sleep quality in T2DM patients in community settings. AIM To test the effect of CBT delivered by general practitioners in improving sleep quality and reducing glycemic levels in patients with T2DM in community. METHODS A cluster randomized controlled trial was conducted from September 2018 to October 2019 in communities of China. Overall 1033 persons with T2DM and poor sleep quality received CBT plus usual care or usual care. Glycosylated hemoglobin A1c (HbAlc) and sleep quality [Pittsburgh Sleep Quality Index (PSQI)] were assessed. Repeated measures analysis of variance and generalized linear mixed effects models were used to estimate the intervention effects on hemoglobin A1c and sleep quality. RESULTS The CBT group had 0.64, 0.50, and 0.9 lower PSQI scores than the control group at 2 mo, 6 mo, and 12 mo, respectively. The CBT group showed 0.17 and 0.43 lower HbAlc values than the control group at 6 mo and 12 mo. The intervention on mean ΔHbAlc values was significant at 12 mo ( t = 3.68, P < 0.01) and that mean ΔPSQI scores were closely related to ΔHbAlc values ( t = 7.02, P < 0.01). Intention-to-treat analysis for primary and secondary outcomes showed identical results with completed samples. No adverse events were reported. CONCLUSION CBT delivered by general practitioners, as an effective and practical method, could reduce glycemic levels and improve sleep quality for patients with T2DM in community.

The Effectiveness of Cognitive Behavioral Therapy-Based Intervention on Improving Sleep-Related Outcomes for People with Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…CBT significantly improved sleep quality with a moderate effect size compared to the control group when studies reported CBT-based intervention with six sessions (n = 2) 29 , 34 (effect size=−0.25, 95% CI −0.38 to –0.13, Z = 4.13, p < 0.0001, I 2 =0%). Moreover, the CBT group showed statistically significant improvements in sleep quality with a large effect size compared with the control group when studies reported CBT-based intervention with more than six sessions (n = 2) 30 , 33 (effect size=−0.89, 95% CI −1.76 to –0.02, Z = 2.00, p = 0.05, I 2 =95%) (see Figure 4 ).…”

“…31 , 32 Six studies did not report adverse events; only one reported that the adverse events 14.28% in the CBT group, while in the control group the rate of adverse event is 0. 34 Two studies performed Intention-to-treat analysis, 29 , 32 four studies were conducted under protocols guideline. 29 , 30 , 34 , 35 Table 1 provides details of study characteristics.…”

“… 34 Two studies performed Intention-to-treat analysis, 29 , 32 four studies were conducted under protocols guideline. 29 , 30 , 34 , 35 Table 1 provides details of study characteristics.…”

“…There were a total of 2633 participants across the studies, with individual sample sizes ranging from 28 34 to 1142. 29 A total of 1308 participants with diabetes in the intervention group, and 1325 in the control groups, were included. Among the participants in the study, there were a wide range of ages, from 18 to 90 years old.…”

“…Participants in CBT-I received several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. Three out of seven studies conducted six sessions of CBT in six weeks to three months, 29 , 34 , 35 two studies conducted eight sessions in two months, 30 , 31 and one study conducted 12 sessions in six months. 33 Across all interventions, each session ranged from 20 min to 60 min, with the majority of sessions (n = 4) lasting 40–60 min.…”