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A digital self-care intervention for psychological distress associated with premenstrual syndrome: a fully online
Yumie Ikeda1,2, Miho Egawa3, Takuma Ohsuga3
1Department of Health Informatics, Kyoto University School of Public Health, Konoe-cho Yoshida, Sakyo-ku, Kyoto, 606-8303, Japan. yumieikeda@gmail.com.
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.
