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Not Yet Recruiting NCT07672002

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

Conditions: Menopause, Perimenopause

Sex: Female
Ages: 40 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 150
Sponsor: University of Coimbra

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Being female; * Being between 40 and 60 years old; * Being in perimenopause or natural post-menopause; * Residence in Portugal; * Having access to a computer, tablet, or smartphone and internet (a necessary - condition to complete the program); * Being able to read and write in Portuguese. Exclusion Criteria: * Having menopause induced by medical or surgical reasons; * Presence of a severe physical medical condition (self-reported); * Presence of a severe psychiatric illness (self-reported); * Presence of suicidal ideation.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07672002). StuddyBuddy aggregates publicly available trial information.