Evaluating a Mobile Digital Therapeutic for Vasomotor and Behavioral Health Symptoms Among Women in Midlife: Randomized Controlled Trial

Unlabelled: Background: Perimenopausal and menopausal symptoms affect many women's well-being and quality of life. Digital technologies, especially smartphones, allow self-management interventions for menopausal symptoms, but they are understudied., Objective: We evaluated whether a novel digital care app, Caria, effectively reduced vasomotor and behavioral health symptoms of menopause., Methods: We enrolled 149 women for a 6-week randomized controlled trial (app treatment: n=112; web-based educational control: n=37). Enrolled participants had problematic vasomotor symptoms and at least one elevated behavioral health symptom (depression, anxiety, or sleep issues). Web-based self-reported assessments (Hot Flush Rating Scale [HFRS], Patient Health Questionnaire Depression Scale-8 [PHQ-8], Generalized Anxiety Disorder-7, and Pittsburgh Sleep Quality Index [PSQI]) were conducted at baseline, 3 weeks, and 6 weeks., Results: For hot flash severity (HFRS; treatment baseline mean 16.4, SD 6.7 to 6-wk mean 13.6, SD 6.6; control: baseline mean 19.1, SD 7.3 to 6-wk mean 17.8, SD 7.2), a repeated-measures ANOVA revealed main effects for time (F2,262=9.82; P<.001) and treatment arm (F1,131=6.08; P=.01) and a significant time × treatment arm interaction (F2,262=3.23; P=.04); the treatment arm showed lower hot flash severity than the control arm (t147=2.72; P=.007). For depression scores (PHQ-8; treatment baseline mean 14.0, SD 3.8 to 6-wk mean 11.2, SD 5.3; control baseline mean 15.0, SD 3.7 to 6-wk mean 13.4, SD 4.1), a repeated-measures ANOVA showed a main effect of time in the treatment arm (F2,96=15.2; P<.001) but not the control arm (F2,40=2.0; P=.15). Follow-up 2-tailed paired t tests in the treatment arm showed depression decreased from baseline to week 3 (t49=3.3; P=.002) and from weeks 3 to 6 (t48=2.3; P=.02). For sleep quality scores (PSQI; treatment baseline mean 10.7, SD 3.1 to 6-wk mean 10.0, SD 3.5; control baseline mean 11.5, SD 3.7 to 6-wk mean 11.0, SD 3.7), the repeated-measures ANOVA showed a main effect of time in the treatment arm (F2,186=7.8; P=.001) but not the control arm (F2,62=1.3; P=.28). Follow-up 2-tailed paired t tests in the treatment arm showed a significant decrease in sleep issues from baseline to week 3 (t95=3.9; P<.001) but no change from weeks 3 to 6 (t93=0.2; P=.81). Participants with elevated anxiety symptoms showed decreased symptoms in both the treatment and control groups. App engagement was high (average logins over 6 weeks: 53.2)., Conclusions: The findings highlight the potential of digital interventions for mitigating menopausal vasomotor and behavioral health symptoms. Significant improvements 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 evidence supporting digital health interventions in managing menopausal symptoms, presenting a promising avenue for accessible and scalable solutions for women in midlife.