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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ana Fonseca
- 電話番号：+351 239851450
- メール：anadfonseca@fpce.uc.pt
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes from baseline in quality of life
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes from baseline in anxiety and depressive symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Cuidar-ME/2026
- 2023.00144.RESTART (その他の助成金/資金番号：Fundação para a Ciência e a Tecnologia)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Cuidar-MEの臨床試験
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MEI Pharma, Inc.終了しました辺縁帯リンパ腫 | 非ホジキンリンパ腫 | 濾胞性リンパ腫（FL）アメリカ, スペイン, 大韓民国, ベルギー, 台湾, ドイツ, フランス, イタリア, オーストラリア, ポーランド, ニュージーランド, イギリス, オーストリア, スイス