No phaseActive, not recruiting

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

A Pilot Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Preliminary Efficacy of a Web-based Psychological Intervention to Promote Well-being and Mental Health During (Peri)Menopause

Sponsor
University of Coimbra (Academic or other)
Enrolment
150 planned
Conditions
Menopause; Perimenopause
Interventions
Cuidar-ME
Ages
adults
Registry
NCT07672002

From the registry

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…

Primary outcomes

  • Changes from baseline in quality of life
Full record on ClinicalTrials.gov