Cuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial

The Cuidar-ME program is a web-based cognitive-behavioral intervention designed to promote well-being and mental health in women during (peri)menopause. The main goal of this research is to evaluate its acceptability, feasibility and preliminary evidence of efficacy of the intervention. This pilot randomized controlled trial uses a two-arm design and serves as a preliminary step before a full-scale RCT. A sample of at least 150 (peri)menopausal women, aged 40 to 60, will be recruited online. Participants who meet the eligibility criteria will be randomly assigned to either the web-based intervention (Cuidar-ME) or a waitlist control condition (which will receive access to the program after the study concludes). Participation in this study will last approximately 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline and post-intervention assessments. These assessments will include self-report questionnaires evaluating several outcomes (e.g., quality of life, menopausal symptoms, depressive and anxiety symptoms, menopause representations, etc.), potential mechanisms of treatment response (emotional regulation and self-compassion), as well as user acceptability and feasibility.

NCT Number	NCT07672002
Lead Sponsor	University of Coimbra
Conditions	Menopause, Perimenopause
Enrollment	150 participants
Start Date	2026-09-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-30