A randomized controlled trial comparing mobile-app-based cognitive behavioral therapy with and without therapist support versus face-to-face therapy: study protocol.

Background: 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.

Objective: 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).

Methods: 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.

Discussion: 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.