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

Sponsor
University of Coimbra
Study ID
NCT07672002
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Cuidar-ME — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Web-based intervention (Cuidar-ME program)
    Women will receive a web-based intervention designed to promote well-being and mental health in women during (peri)menopause (the Cuidar-ME program). Cuidar-ME is a self-guided web-based intervention grounded in CBT principles.
  • No Intervention: Control (waiting list)
    Women will not receive the intervention during the study period but will be offered the Cuidar-ME program after the post-intervention assessment is completed.

Primary Outcome Measure

Changes from baseline in quality of life [ Time Frame: Baseline and post-intervention (11 weeks after randomization) ]

Central Contacts

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