Effectiveness of a Digital Self-care Application Based on Cognitive Behavioral Change in Addressing Subthreshold Depression in Perimenopausal Women: A randomized controlled trial (Japanese)

Objective: This study examined the effectiveness of a digital healthcare intervention based on a cognitive behavioral approach for women suffering from depressive symptoms caused by physical and psychosocial changes associated with menopause. Methods: Women aged 40 to under 60 years were recruited online, and 968 participants who met the eligibility criteria were randomly assigned to an intervention group (n = 488) or a control group (n = 480). For four weeks the intervention group was provided with a self-care application mainly focused on psychoeducation (five days per week). The primary outcome was measured with the “Coping with Menopausal Symptoms Scale.” Secondary outcomes included depressive symptoms (PHQ-9), anxiety symptoms (GAD-7), menopausal symptoms (Simplified Menopausal Index: SMI), and mental well-being (WHO-5). Data were analyzed using a mixed model for repeated measures (MMRM). Results: For the primary outcome, the intervention group did not show a statistically significant improvement compared with the control group. For PHQ-9, GAD-7, and WHO-5 the intervention group showed significant improvements compared with the control group. No significant difference was observed in the SMI between the two groups. Limitations: Only 238 participants (approximately 50%) in the intervention group implemented the intervention, and outcome measures were not collected from participants who did not participate in the intervention. Therefore, the effects of the intervention may have been overestimated. Conclusion: This digital self-care intervention may be effective in improving depressive symptoms, anxiety symptoms, and subjective well-being among perimenopausal and menopausal women.