Evaluating a Mobile Digital Therapeutic for Vasomotor and Behavioral Health Symptoms Among Women in Midlife: Randomized Controlled Trial
Abstract
Abstract 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 149 participants or records.
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