Insomnia affects up to 50% of patients with cardiovascular diseases (CVD) and is associated with poor clinical outcomes. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia, but little is known on the effects of CBT-I in patients with established CVD. We aimed to investigate the effects of CBT-I on insomnia symptom severity, sleep parameters, and daytime symptoms in patients with CVD and comorbid insomnia. Medline, Embase, PsycINFO and ClinicalTrials.gov were searched for randomized controlled and open trials up to December 2023. Study selection, data extraction, and risk of bias assessment (Cochrane's risk of bias 2 tool) were independently conducted by co-authors. Data were meta-analyzed using random-effects models. In all, 1275 records with five studies fulfilled the inclusion criteria (n=352 patients). Compared with active control groups, CBT-I significantly reduced insomnia severity post-treatment (standardized mean difference [SMD] = -0.90, 95%CI: -1.43, -0.37, p < .001), sleep onset latency (SOL), anxiety, and fatigue. Moreover, CBT-I significantly improved sleep quality (SMD = -0.77, 95%CI: -1.10, -0.45, p < .001) and sleep efficiency (SMD = 0.68, 95%CI: 0.12-1.25, p < .001). We regarded three RCTs as having low risk of bias, and had some concerns with another. Evidence from our analyses indicated that CBT-I seems to be effective for alleviating insomnia symptoms among CVD patients, largely in line with the results of previous meta-analyses in patients with insomnia. The limited sample size encourages more robust evidence from high-quality, large-scale trials with long-term follow-up. Registry: PROSPERO; Identifier: CRD4202448873; Title: Effects of cognitive behavioral therapy for insomnia in patients with coronary heart disease: A systematic review; URL: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024488739.
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