MenopauseCuidar-MENCT07672002
Cuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial
A study testing Cuidar-ME in people with Menopause and Perimenopause, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Perimenopause
- What is being tested?
- Cuidar-ME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Menopause, Perimenopause
- Being tested
- Cuidar-ME
- Keywords
- Menopause, Cognitive-Behavioral Therapy, Web-Based Intervention, Quality of Life, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuidar-MEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
Secondary outcomes (10)
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
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).
Measured: Baseline and post-intervention (11 weeks after randomization)
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in menopause representations
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in menopause-related shame
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in self-compassion
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
Changes from baseline in emotional regulation
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.
Measured: Baseline and post-intervention (11 weeks after randomization)
Acceptability of the program for (peri)menopausal women
Measured through specific questions developed by the researchers to assess acceptability.
Measured: Measured at post-intervention (11 weeks after randomization)
Feasibility of the program for (peri)menopausal women
Measured through website utilization (e.g., number of logins, number of exercises completed) and dropout rate.
Measured: Measured at post-intervention (11 weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Fonseca, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672002
- Sponsor's protocol ID
- Cuidar-ME/2026
- Other IDs
- 2023.00144.RESTART, 2023
- Acronym
- Cuidar-ME
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.
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 at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07672002
- Acronym / sponsor ID
- Cuidar-ME / Cuidar-ME/2026
- Conditions
- Menopause, Perimenopause
- Keywords
- Menopause, Cognitive-Behavioral Therapy, Web-Based Intervention, Quality of Life, Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention (Cuidar-ME program) | Experimental | Behavioral: Cuidar-MEWomen 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. |
| 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuidar-MECuidar-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. | Behavioural | Web-based intervention (Cuidar-ME program) |
Primary outcome
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.
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BackgroundBranquinho, 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
- Individual participant dataSharing planned: Undecided. After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.
Related trials for Menopause
RecruitingObservational study
Health, Imaging, and Cognition Across the Menopausal Transition
Menopause
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruiting
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Menopause, Vasomotor Symptoms (VMS)
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
RecruitingObservational study
QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
Cancer, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cuidar-ME in people with Menopause and Perimenopause, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in quality of life (time frame: Baseline and post-intervention (11 weeks after randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07672002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.