The Effectiveness of a 6-Week Online Mindfulness-Based Intervention on Patients With Cervical Cancer or High-Grade Squamous Intraepithelial Lesion: A Randomized Controlled Trial Using Multimodal Data of Scales and Electroencephalogram.

BACKGROUND: Patients with cervical cancer or High-Grade Squamous Intraepithelial Lesion (HSIL) often experience mental problems such as anxiety and depression. Online mindfulness-based interventions offer accessible mental health support. However, evidence for cervical cancer or HSIL patients remains scarce, and evaluations often rely solely on self-reported scales, with a lack of neurophysiological assessments. This study aimed to assess the effectiveness of a 6-week online mindfulness-based intervention on mental health outcomes in this population by using scales, with exploratory frontal electroencephalogram (EEG) biomarkers as supplementary neurophysiological indicators. METHODS: A single-center randomized controlled trial enrolling 151 cervical cancer or HSIL patients was conducted. The intervention group received a 6-week online mindfulness-based intervention, while the control group received general mental health education. Primary outcomes were depressive and anxiety symptoms assessed by validated scales. Frontal EEG metrics were collected as exploratory supplementary neurophysiological indicators. Assessments were conducted at baseline and post-intervention. Independent samples t-tests and Mann-Whitney U tests were used for intergroup comparisons, with Benjamini-Hochberg FDR correction applied to control for multiple testing. RESULTS: A total of 149 patients completed the study. After the intervention, the intervention showed significantly lower symptoms of depression (t = 12.238, FDR-q < 0.001), anxiety (t = 11.150, FDR-q < 0.001), and higher levels of resilience, mindfulness, and perceived social support than the control group. Exploratory EEG analysis revealed that the intervention group exhibited higher relative theta and alpha power, higher time-domain standard deviation, and lower relative beta and gamma power than the control group. CONCLUSION: This study demonstrates that a 6-week online mindfulness-based intervention effectively alleviates depressive and anxiety symptoms among patients with cervical cancer or HSIL. Exploratory EEG findings provide preliminary neurophysiological support for these psychological benefits, though further validation with larger samples is warranted. TRIAL REGISTRATION: The trial was prospectively registered on the Chinese Clinical Trial Registry (ID: ChiCTR2400087926, https://www.chictr.org.cn/) on August 07, 2024.