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

Study acronym: Cuidar-ME
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 8 of 10 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Recruitment opened
    • Study sites: 0 to 1
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07672002
Lead Sponsor University of Coimbra
Conditions
(from sponsor)		 Menopause, Perimenopause
Related terms Psychological Well-Being
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov