Effect of mobile-based cognitive behavior therapy (CBT) on lowering of blood lipid levels in atherosclerotic cardiovascular disease (ASCVD) patients: study protocol for a multicenter, prospective, randomized controlled trial

BACKGROUND: Atherosclerotic cardiovascular disease (ASCVD) remains a major source of mortality in China. Convincing evidence has demonstrated that the reduction of low-density lipoprotein cholesterol (LDL-C) is correlated with lowering ASCVD risk. The efficacy of lifestyle management in lipid levels reduction has been confirmed in numerous studies. However, considering that low compliance to lifestyle management has limited the benefits of lowering lipid levels, cognitive behavior therapy (CBT) is proposed as a solution to improve clinical outcomes. The objective of this trial is to compare the LDL-C outcome in ASCVD patients receiving mobile device-based CBT to a control group, with both groups under standard pharmacological treatments. METHODS: This trial is designed as a multicenter, prospective randomized controlled trial with a 6-month follow-up. Mean LDL-C level and the percentage of different LDL-C levels, coefficient of variation of LDL, General Self-Efficacy Scale (GSEs), quality of life index (QL-index), etc., between the two groups at baseline, 1, 3, and 6 months will be measured. DISCUSSION: This trial should demonstrate that the implementation of mobile-based CBT intervention will be potentially effective in lowering LDL-C levels in ASCVD patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2100046775) [registered: 2021/5/28].