JMIR Publications

ABSTRACT

Background:

In midlife, many women experience significant physical and psychological symptoms associated with menopause, impacting their well-being and quality of life. While behavioral interventions are effective in alleviating these symptoms, access can be challenging. Digital technology, especially smartphones, offers a promising avenue for delivering self-management interventions for menopausal symptoms, but research in this domain remains limited.

Objective:

This study aimed to evaluate the efficacy of a novel digital care program, the Caria App, in reducing vasomotor and behavioral health symptoms among women experiencing menopause.

Methods:

The study enrolled 149 women for a randomized control trial, with 112 in the treatment group and 37 in the control group. Enrolled participants had problematic vasomotor symptoms and at least one elevated behavioral health symptom (depression, anxiety, or sleep issues). Participants were recruited online and randomized into a treatment group, receiving access to the self-guided Caria App for six weeks, and a control group, provided with online educational materials. The Caria app utilizes approaches such as CBT, mindfulness, and mobility for menopausal symptom management. Web-based self-reported assessments using the Hot Flush Rating Scale, PHQ8, GAD7, and PSQI were conducted at baseline, 3 weeks, and 6 weeks.

Results:

At 6 weeks, the treatment group showed significant improvements in hot flush distress (p<.001), depression (p<.001), and sleep quality (p=.001), while the control group showed no significant changes. Specifically, for those in the treatment group, distress from hot flashes decreased by 17.1%, depression symptoms decreased by 12.3%, and sleep problems decreased by 5.9%. The depression effect size was comparable to therapist-delivered interventions for depression in similar mildly distressed populations. The control group experienced improvement in hot flash symptoms and anxiety in the first 3 weeks of the study. However, those who used Caria showed additional improvement in hot flash distress and depression in the second half of the intervention (3 weeks - 6 weeks) while there was no change in the control group. Those with elevated anxiety symptoms who used Caria also showed a decrease in symptoms, but so did those in the control group. Engagement with the Caria app was high, with an average of 53.2 logins over 6 weeks.

Conclusions:

The findings of this study highlight the potential of digital interventions for mitigating vasomotor and behavioral health symptoms associated with menopause. The significant improvements observed in the intervention group underscore the app's effectiveness in providing relief from some of the most challenging aspects of menopause. This study contributes to the growing body of evidence supporting digital health interventions in managing menopausal symptoms, presenting a promising avenue for accessible and scalable solutions for women in midlife. Clinical Trial: ClinicalTrials.gov NCT04882982