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

NCT07672002 | Not Yet Recruiting

• 2 other identifiers: Cuidar-ME/20262023.00144.RESTART
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Menopause; Perimenopause

Keywords

Menopause; Cognitive-Behavioral Therapy; Web-Based Intervention; Quality of Life; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and post-intervention (11 weeks after randomization)

Secondary Outcomes (10)

• Changes from baseline in anxiety and depressive symptoms

  Baseline and post-intervention (11 weeks after randomization)

• Changes from baseline in positive mental health

  Baseline and post-intervention (11 weeks after randomization)

• Changes from baseline in menopausal symptoms

  Baseline and post-intervention (11 weeks after randomization)

• Changes from baseline in insomnia severity and impact

  Baseline and post-intervention (11 weeks after randomization)

• Changes from baseline in menopause representations

  Baseline and post-intervention (11 weeks after randomization)

Study Arms (2)

Web-based intervention (Cuidar-ME program)

EXPERIMENTAL

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.

Behavioral: Cuidar-ME

Control (waiting list)

NO INTERVENTION

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.

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.

Web-based intervention (Cuidar-ME program)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being female;
• Being between 40 and 60 years old;
• Being in perimenopause or natural post-menopause;
• Residence in Portugal;
• Having access to a computer, tablet, or smartphone and internet (a necessary - condition to complete the program);
• Being able to read and write in Portuguese.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead

Related Publications (1)

• Branquinho, M., Monteiro, F., & Fonseca, A. (2026). Development of a CBT-Based e-Health Intervention for Menopausal Symptoms ("Cuidar-ME"): Perspectives from Mental Health Professionals and (Peri)menopausal Women. International Journal of Cognitive Behavioral Therapy, 19, 33-59. https://doi.org/10.1007/s41811-025-00266-z

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Ana Fonseca

CONTACT

+351 239851450; anadfonseca@fpce.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06