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

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Li, Yanni
Buys, Nicholas
Ferguson, Samantha
Li, Zhiyong
Shi, Yan-Chun
Li, Li
Sun, Jing
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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:

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Diabetology & Metabolic Syndrome

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© The Author(s) 2023. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

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Clinical sciences

Medical biochemistry and metabolomics

Public health

Cognitive Behavior Therapy

Health outcomes

Metabolic Syndrome

Type 2 diabetes

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Li, Y; Buys, N; Ferguson, S; Li, Z; Shi, Y-C; Li, L; Sun, J, The evaluation of cognitive-behavioral therapy-based intervention on type 2 diabetes patients with comorbid metabolic syndrome: a randomized controlled trial, Diabetology & Metabolic Syndrome, 2023, 15, pp. 158