Cuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial (Cuidar-ME)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ana Fonseca
- Número de telefone: +351 239851450
- E-mail: anadfonseca@fpce.uc.pt
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes from baseline in quality of life
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes from baseline in anxiety and depressive symptoms
Prazo: 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.
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Baseline and post-intervention (11 weeks after randomization)
|
|
Changes from baseline in positive mental health
Prazo: 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).
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Baseline and post-intervention (11 weeks after randomization)
|
|
Changes from baseline in menopausal symptoms
Prazo: 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.
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Baseline and post-intervention (11 weeks after randomization)
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Changes from baseline in insomnia severity and impact
Prazo: Baseline and post-intervention (11 weeks after randomization)
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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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Baseline and post-intervention (11 weeks after randomization)
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Changes from baseline in menopause representations
Prazo: 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.
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Baseline and post-intervention (11 weeks after randomization)
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Changes from baseline in menopause-related shame
Prazo: 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.
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Baseline and post-intervention (11 weeks after randomization)
|
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Changes from baseline in self-compassion
Prazo: 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.
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Baseline and post-intervention (11 weeks after randomization)
|
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Changes from baseline in emotional regulation
Prazo: 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.
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Baseline and post-intervention (11 weeks after randomization)
|
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Acceptability of the program for (peri)menopausal women
Prazo: Measured at post-intervention (11 weeks after randomization)
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Measured through specific questions developed by the researchers to assess acceptability.
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Measured at post-intervention (11 weeks after randomization)
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Feasibility of the program for (peri)menopausal women
Prazo: Measured at post-intervention (11 weeks after randomization)
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Measured through website utilization (e.g., number of logins, number of exercises completed) and dropout rate.
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Measured at post-intervention (11 weeks after randomization)
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Cuidar-ME/2026
- 2023.00144.RESTART (Número de outro subsídio/financiamento: Fundação para a Ciência e a Tecnologia)
Plano para dados de participantes individuais (IPD)
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