Mindfulness-based cognitive therapy for health-related and work-related quality of life in working women with premenstrual syndrome: A cluster randomized controlled trial

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This cluster randomized controlled trial examined whether mindfulness-based cognitive therapy (MBCT) improves health-related quality of life (HRQoL), work-related quality of life (WRQoL), and reduces the impact of premenstrual syndrome (PMS) on daily life among working women with PMS. From August 2023 to May 2024, working women from 20 schools were randomized into intervention or control groups, yielding 110 working women with PMS (55 per group). The intervention comprised eight weekly 45–60-minute group MBCT sessions. Outcomes included HRQoL (SF-12), WRQoL, the impact of PMS on daily life (IPMSDLS), and mindfulness (FFMQ-15). The prespecified primary analysis (linear mixed-effects models with school as a random intercept) found no significant intervention effects on any outcome (all p > 0.05). In secondary, exploratory repeated-measures ANCOVA analyses not accounting for school-level clustering, the MBCT group showed significantly greater improvements across all outcomes, with medium effect sizes (partial η2 = 0.108–0.149; all p < 0.001); these exploratory findings were not confirmed in the primary analysis and should be interpreted with caution. Because the cluster-adjusted primary analysis did not confirm a significant intervention effect, the findings do not provide evidence of MBCT effectiveness, although the consistent direction of exploratory findings suggests MBCT may warrant further evaluation in adequately powered cluster-randomized trials.RCT registration The study protocol was prospectively registered in the Iranian Registry of Clinical Trials under decree code IRCT20221213056810N1; 2023-05-05.