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

June 26, 2026 updated by: Ana Fonseca, University of Coimbra

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in quality of life
Time Frame: Baseline and post-intervention (11 weeks after randomization)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in anxiety and depressive symptoms
Time Frame: Baseline and post-intervention (11 weeks after randomization)
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.
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)
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).
Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in menopausal symptoms
Time Frame: Baseline and post-intervention (11 weeks after randomization)
Measured with the 10-item Cervantes Scale (CS-10). The total score ranges from 0 to 50, and higher scores indicate higher symptom severity.
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)
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.
Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in menopause representations
Time Frame: Baseline and post-intervention (11 weeks after randomization)
Measured with the Menopause Representations Questionnaire, which comprises four subscales: identity, negative consequences, positive consequences, and control/awareness/cause. The total score for each subscale ranges from 1 to 5, with higher scores indicating stronger beliefs regarding that specific dimension.
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)
Measured with an adapted version of the Chronic Illness-related Shame Scale. (CISS) for menopause. The total score ranges between 0 and 28, and higher scores indicate a higher level of shame associated with menopause.
Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in self-compassion
Time Frame: Baseline and post-intervention (11 weeks after randomization)
Measured with the Self-Compassion Scale - Short Form (SCS-SF). The total score ranges between 12 and 60, and higher scores indicate higher levels of self-compassion.
Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in emotional regulation
Time Frame: Baseline and post-intervention (11 weeks after randomization)
Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). The total score can range between 18 and 90, and higher scores are indicative of more difficulties in emotion regulation.
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)
Measured through specific questions developed by the researchers to assess acceptability.
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)
Measured through website utilization (e.g., number of logins, number of exercises completed) and dropout rate.
Measured at post-intervention (11 weeks after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cuidar-ME/2026
  • 2023.00144.RESTART (Other Grant/Funding Number: Fundação para a Ciência e a Tecnologia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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