What question did this study set out to answer?

To assess the effectiveness of a low-intensity digital intervention on psychological distress associated with PMS among women.

May 21, 2026BMC Women s Health0 citationsOpen Access

A digital self-care intervention for psychological distress associated with premenstrual syndrome: a fully online controlled trial using alternating allocation

YIYumie IkedaKyoto University MEMiho EgawaKyoto University TOTakuma OhsugaKyoto University

Key Points

To assess the effectiveness of a low-intensity digital intervention on psychological distress associated with PMS among women.
Conducted a fully internet-based, open-label, parallel-group, nonrandomized controlled trial in Japan.
Participants aged 18 or older self-identified as experiencing PMS and were alternately assigned to intervention or control groups.
The intervention involved daily symptom tracking via a smartphone app and twice-weekly informational emails over 3 months.
The intervention group (n = 210) showed greater improvement in self-reported psychological distress than the control group (n = 209).
The between-group difference in change score was −1.37 points (95% CI, −2.47 to −0.27; p = 0.015).
The digital self-care intervention demonstrated potential as a self-management strategy for psychological distress associated with PMS.

Abstract

Abstract Background Premenstrual syndrome (PMS) is associated with significant psychological distress and productivity loss in women. This study aimed to evaluate whether a low-intensity digital intervention—comprising a symptom-tracking smartphone application and standardized informational emails—could reduce the psychological burden of PMS among women who self-identified as experiencing PMS. Methods We conducted a fully internet-based, open-label, parallel-group, nonrandomized controlled trial using centrally administered alternating allocation among women aged 18 years or older in Japan who self-identified as experiencing PMS. Participants were allocated alternately to either a 3-month intervention group (daily symptom tracking using a smartphone app and twice-weekly informational emails) or a waitlist control group. The primary outcome was the between-group difference in change scores on the psychological subscale of the Japanese version of the PMS-Impact Scale, measured from baseline to 3 months. Analyses were conducted per protocol. Results A total of 419 women were enrolled and assigned to either the intervention group (n = 210) or the waitlist control group ( n = 209). Of these, 355 participants were included in the per-protocol analysis. The intervention group showed greater improvement in self-reported psychological distress than the waitlist control group. The between-group difference in change score, defined as intervention minus control, was − 1.37 points (95% CI, − 2.47 to − 0.27; p = 0.015). Conclusions A simple, scalable digital intervention was associated with greater improvement in self-reported psychological distress among women who self-identified as experiencing PMS. These findings suggest that accessible, non–clinician-led tools may have potential as a self-management strategy for PMS, although causal interpretation is limited by the nonrandomized design. Trial registration This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) on September 26, 2022. Trial registration number: UMIN000048422.

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