Evaluating a Mobile Digital Therapeutic for Vasomotor and Behavioral Health Symptoms Among Women in Midlife: Randomized Controlled Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".