A randomized controlled trial comparing mobile-app-based cognitive behavioral therapy with and without therapist...

Hot flashes and night sweats (HFNS), the primary symptoms of the menopausal transition, can greatly affect women's quality of life. There is substantial evidence that cognitive-behavioral interventions positively influence the management of HFNS in women.

The aim of this study is to evaluate the effectiveness of a mobile-app-based cognitive-behavioral therapy (Meno-iCBT) on the problem rating of hot flashes and night sweats (HFNS).

Women aged 45 to 60 who experience seven or more problematic HFNS per week will be selected for a multi-center, randomized, controlled trial without blinding. A total of 180-210 menopausal transition or postmenopausal women will be randomly assigned to three groups: two mobile-app-based intervention groups of CBT (with or without therapist support) and one comparison group (face-to-face education). The primary outcome is the impact on HFNS 16 weeks after randomization. Secondary outcomes include the impact on HFNS 6 weeks after randomization, quality of life for menopausal women, sleep quality, and the quality of marital relationships, which will be evaluated using self-report questionnaires at baseline (T0), 6 weeks post-intervention (T1), and 16 weeks post-intervention (T2). The effectiveness of the program will be assessed based on intention-to-treat analysis.

This study will be the first clinical trial to assess the effectiveness of a mobile-app-based cognitive-behavioral therapy (Meno-iCBT) in reducing the impact of HFNS in menopausal women in Iran. If this program is proven effective, it could serve as a highly cost-effective method for improving the quality of life for menopausal women.