RecruitingNot ApplicableNCT07672002

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

Enrollment

150 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 40 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Cuidar-ME for people with menopause and perimenopause. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCuidar-ME

Cuidar-ME is a self-guided web-based intervention structured into 8 weekly thematic modules grounded in CBT principles. Each module targets specific thematic content and delivers information and therapeutic strategies through text, audio and video formats. Access to the initial modules is sequential, and three subsequent modules are optional, allowing women flexibility to autonomously select content according to their individual needs.


Locations(1)

University of Coimbra

Coimbra, Portugal

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NCT07672002


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