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Background <p>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.</p> Methods <p>We conducted a fully internet-based, open-label, parallel-group, nonrandomized controlled trial using centrally administered alternating allocation among women aged 18&#xa0;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&#xa0;months. Analyses were conducted per protocol.</p> Results <p>A total of 419 women were enrolled and assigned to either the intervention group (n = 210) or the waitlist control group (<i>n</i> = 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; <i>p</i> = 0.015).</p> Conclusions <p>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.</p> Trial registration <p>This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) on September 26, 2022. Trial registration number: UMIN000048422.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Yumie Ikeda,
  • Miho Egawa,
  • Takuma Ohsuga,
  • Eiji Nakatani,
  • Kaori Tsuyuki,
  • Yoshimitsu Takahashi,
  • Takeo Nakayama,
  • Masaki Mandai

摘要

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.