Cuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cuidar-ME.
- Who it may be relevant to
- Registry conditions: Menopause, Perimenopause. Basic parameters: 40 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
In this study, a web-based intervention to promote mental health and quality of life of women during (peri)menopause (the Cuidar-ME program) will be tested. The development of the Cuidar-ME program was informed by a literature review about the characteristics and content of cognitive-behavioral interventions for menopausal symptoms, a focus group with health professionals and an online survey with the target population.
Cuidar-ME is self-guided web-based intervention grounded in cognitive-behavioral therapy (CBT) principles. It is structured into 8 thematic modules: 1) Menopause; 2) Emotions; 3) Thoughts; 4) Lyfestyle \& Self-care; 5) Sleep; 6) Interpersonal relationships; 7) Sexuality \& Intimacy; 8) Final Balance. Each module targets specific thematic content and delivers information and therapeutic strategies through text, audio and video formats. The program also includes interactive exercises with personalized feedback to support learning. 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.
The main goal of the research is to apply and evaluate the web-based intervention (the Cuidar-ME program), in terms of its acceptability, feasibility and preliminary efficacy. The research design of the pilot trial followed the methodological recommendations for the development and evaluation of web-based interventions.
This pilot study uses a two-arm randomized controlled trial (RCT) design. The intervention condition (the Cuidar-ME program) will be compared with a control condition (waitlist). The sample will include women during the (peri)menopause aged between 40 and 60 years old. Recruitment will be conducted online through the dissemination of the study on social media and other forums related to the topic of menopause. An anticipated sample of 150 women will be enrolled in the study. Women who demonstrate interest in the study will be informed of the study goals, structure and the researchers' and participants' roles. Women who agree to participate in the study will provide their informed consent. All ethical requirements for research with humans are guaranteed.
After women's agreement to participate in the study, women will be asked to complete an online self-report questionnaire to assess eligibility. Women who do not fulfill the eligibility criteria will end their participation in the study. Eligible participants will be randomly assigned (1:1 ratio, blocked randomization, with allocation concealment) to one of the conditions: the intervention (Cuidar-ME program) or control group (waitlist). The randomization sequence will be generated prior to study onset using a computerized random number generator.
Participation in the study will last about 3 months. The intervention will last about 8 weeks. Participants in both arms will be invited via email to complete baseline and post-intervention assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., quality of life, depressive and anxiety symptoms, menopausal symptoms), underlying therapeutic mechanisms (e.g., self-compassion, emotional regulation) and user's acceptability. The necessary statistical analyses will be conducted, using the intention-to-treat (ITT) principles.
Interventions
- Behavioral Cuidar-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.
Primary outcome measures
- Changes from baseline in quality of life [Time frame: Baseline and post-intervention (11 weeks after randomization)]
Secondary outcome measures (10)
- Changes from baseline in anxiety and depressive symptoms [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in positive mental health [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in menopausal symptoms [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in insomnia severity and impact [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in menopause representations [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in menopause-related shame [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in self-compassion [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Changes from baseline in emotional regulation [Time frame: Baseline and post-intervention (11 weeks after randomization)]
- Acceptability of the program for (peri)menopausal women [Time frame: Measured at post-intervention (11 weeks after randomization)]
- Feasibility of the program for (peri)menopausal women [Time frame: Measured at post-intervention (11 weeks after randomization)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07672002 · Cuidar-ME/2026 · 2023.00144.RESTART