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

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.

• Changes from baseline in anxiety and depressive symptoms [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in positive mental health [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in menopausal symptoms [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in insomnia severity and impact [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in menopause representations [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in menopause-related shame [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in self-compassion [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Changes from baseline in emotional regulation [Срок оценки: Baseline and post-intervention (11 weeks after randomization)]
• Acceptability of the program for (peri)menopausal women [Срок оценки: Measured at post-intervention (11 weeks after randomization)]
• Feasibility of the program for (peri)menopausal women [Срок оценки: Measured at post-intervention (11 weeks after randomization)]