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.
Being female;
Being between 40 and 60 years old;
Being in perimenopause or natural post-menopause;
Residence in Portugal;
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.
Parallel
Cuidar-ME
BehavioralCuidar-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.
Changes from baseline in quality of life
Measured with the Menopause-Specific Quality of Life Questionnaire (MENQOL). It is composed of four domains (vasomotor, physical, psychosocial, and sexual), each scored from 1 to 8. Higher scores indicate a lower perception of quality of life.
Changes from baseline in anxiety and depressive symptoms
Measured with the Hospital Anxiety and Depression Scale (HADS). The total score for each subscale ranges from 0 to 21, with higher scores being indicative of more severe symptoms.
Changes from baseline in positive mental health
Measured with the Mental Health Continuum-Short Form (MHC-SF). The MHC-SF can be scored continuously (total scores range from 0 to 70, and higher scores indicate better positive mental health) or categorically considering mental health status (flourishing, moderate mental health, languishing).
Changes from baseline in menopausal symptoms
Measured with the 10-item Cervantes Scale (CS-10). The total score ranges from 0 to 50, and higher scores indicate higher symptom severity.
Changes from baseline in insomnia severity and impact
Measured with the Insomnia Severity Index (ISI). Total score ranges from 0 to 28 and are interpreted as follows: no clinical insomnia (0-7); subthreshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher scores indicate higher insomnia severity.
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