The evaluation of cognitive-behavioral therapy-based intervention on type 2 diabetes patients with comorbid metabolic syndrome: a randomized controlled trial.

BACKGROUND: Cognitive behavior therapy (CBT) has been applied in intervention research in diabetes patients with satisfying results. However, there was no research on type 2 diabetes (T2DM) patients with comorbidities. This study aimed to investigate the effectiveness of CBT on psychological variables, behavior variables, quality of life, sleep quality, and physical variables among adult T2DM patients with comorbid metabolic syndrome (MS). METHODS: 281 patients aged 18-75 years were recruited from Ningbo First Hospital in China from October 2021 to March 2022. Patients were randomized to the intervention group (IG, N = 148) or control group (CG, N = 133). Patients in the IG received 12 CBT-based sessions during a six-month intervention time. Patients in the CG received the usual care only. Univariate General Linear Model was used to analyze the effect of CBT-based interventions. The analysis was conducted by SPSS Version 28. RESULTS: Results indicated that CBT-based intervention was superior in the following aspects: relieving depression symptoms: IG (4.11 ± 4.35 vs. 1.99 ± 2.12), CG (3.40 ± 3.26 vs. 2.32 ± 1.88), interaction effect (F = 4.074, P = 0.044); enhancing diabetes self-care behaviors: IG (26.79 ± 12.18 vs. 37.49 ± 10.83), CG (25.82 ± 13.71 vs. 31.96 ± 11.72), interaction effect (F = 5.242, P = 0.022); promoting the efficacy of CBT: IG (47.45 ± 6.83 vs. 50.76 ± 4.98), CG (46.74 ± 6.94 vs. 47.87 ± 5.11), interaction effect (F = 5.198, P = 0.023); improving subjective sleep quality: IG (0.93 ± 0.68 vs. 0.69 ± 0.63), CG (1.03 ± 0.72 vs. 1.01 ± 0.68), interaction effect (F = 3.927, P = 0.048). CONCLUSIONS: The CBT-based intervention was beneficial in improving depression symptoms, diabetes self-care behaviors, the efficacy of CBT, and sleep quality in T2DM patients with comorbid MS. The downtrend of body mass index, systolic blood pressure, diastolic pressure, and glycated hemoglobin was larger in the intervention group but not to a significant level. TRIAL REGISTRATION: This study has been prospectively registered at Australia New Zealand Clinical Trials Registry (Registration ID: ACTRN12621001348842 website: https://www.anzctr.org.au/trial/MyTrial.aspx ).