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

Area of Science:

• Women's Health
• Behavioral Science
• Digital Health Interventions

Background:

• Hot flashes and night sweats (HFNS) significantly impact menopausal women's quality of life.
• Cognitive-behavioral interventions show promise in managing menopausal symptoms.

Purpose of the Study:

• To assess the effectiveness of a mobile-app-based cognitive-behavioral therapy (Meno-iCBT) for reducing hot flashes and night sweats (HFNS).
• To evaluate Meno-iCBT's impact on menopausal symptom severity and related quality of life.

Main Methods:

• A multi-center, randomized controlled trial involving 180-210 menopausal women (aged 45-60) experiencing frequent HFNS.
• Participants were assigned to two Meno-iCBT groups (with/without therapist support) or a face-to-face education control group.
• Outcomes measured at baseline, 6, and 16 weeks included HFNS severity, quality of life, sleep, and marital relationships.

Main Results:

• The study aims to determine the primary impact of Meno-iCBT on HFNS at 16 weeks post-randomization.
• Secondary outcomes will assess earlier symptom changes (6 weeks) and broader quality of life indicators.
• Intention-to-treat analysis will be used to evaluate the program's effectiveness.

Conclusions:

• This trial is the first in Iran to test mobile-app-based CBT (Meno-iCBT) for menopausal HFNS.
• If effective, Meno-iCBT offers a potentially cost-effective solution to enhance menopausal women's quality of life.