Sleeping Through Menopause: study protocol of a randomized controlled trial of menopausal hormone therapy and online guided cognitive behavioural and circadian therapy for insomnia in perimenopausal women suffering from insomnia

van Baarzel F, Broekman BF, van Dijken DK, van Someren EJ, Koning AC
2026 · doi:10.64898/2026.07.22.26358657
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This randomized controlled trial protocol evaluates the effectiveness of menopausal hormone therapy and cognitive behavioral circadian therapy, alone or combined, on insomnia symptoms in perimenopausal women.

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This study protocol outlines a randomized controlled trial designed to evaluate the effectiveness of menopausal hormone therapy and combined cognitive behavioral and circadian therapy for insomnia in perimenopausal women. The research involves 222 participants recruited nationwide via an online platform, who are assigned to receive hormone therapy, psychological intervention, both treatments together, or no treatment as a control group. Primary outcomes focus on changes in insomnia severity over eight and fifteen weeks, while secondary measures include objective sleep data from actigraphy and EEG, climacteric symptoms, and overall mental health status. The paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

ABSTRACT Background About half of the women experience insomnia during the perimenopause, a transitional phase characterised by fluctuations in sex hormones. Insomnia is known to increase the risk of other mental health problems. Therefore, addressing insomnia could potentially prevent or alleviate mental health issues. Unfortunately, it is currently unknown which treatment is most effective in alleviating insomnia during the perimenopause. The Sleeping Through Menopause trial is among the first study to investigate side-by-side two interventions; menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The primary aim of this study is to evaluate the effectiveness of CBCTi and MHT on insomnia symptoms. Methods We plan a repeated measurement, randomised controlled trial (RCT) in perimenopausal women who experience insomnia and climacteric symptoms. The study uses a web-based, nationwide recruitment approach, allowing participants from across the Netherlands to self-enroll via an open-access research website. After informed consent, 222 women will be randomly allocated to one of four conditions in a two-by-two treatment design: 1. MHT, 2. CBCTi, 3. MHT + CBCTi and 4. control. MHT consists of transdermal estradiol patches and progesterone tablets in standard doses. CBCTi addresses sleep and circadian behaviour and cognitive restructuring. The primary study outcome is the change in insomnia symptoms assessed with the Insomnia Severity Index (ISI) after 8 weeks (T1) and 15 weeks (T2) relative to baseline (T0). Secondary outcomes are other subjective sleep quality indicators, objective sleep estimated from actigraphy and headband EEG, changes in climacteric symptoms, hot flash frequency estimated from wrist electrodermal activity, other mental health complaints, and wellbeing and daytime functioning. Furthermore, baseline personal characteristics will be assessed, including the history of hormone-related mental health problems. Discussion This study addresses the gap in research regarding optimal treatment for insomnia during the perimenopause, and how treatments alleviate or prevent other mental health problems and climacteric symptoms including hot flashes. Trial Registration The study was prospectively registered in the National Library of Medicine on May 13 th 2024 as ‘Improving Sleep and Mood in Peri-Menopause’ ( NCT06306404 , https://clinicaltrials.gov/study/NCT06306404?cond=NCT06306404&rank=1 ).
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Abstract

Background About half of the women experience insomnia during the perimenopause, a transitional phase characterised by fluctuations in sex hormones. Insomnia is known to increase the risk of other mental health problems. Therefore, addressing insomnia could potentially prevent or alleviate mental health issues. Unfortunately, it is currently unknown which treatment is most effective in alleviating insomnia during the perimenopause. The Sleeping Through Menopause trial is among the first study to investigate side-by-side two interventions; menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The primary aim of this study is to evaluate the effectiveness of CBCTi and MHT on insomnia symptoms.

Methods

We plan a repeated measurement, randomised controlled trial (RCT) in perimenopausal women who experience insomnia and climacteric symptoms. The study uses a web-based, nationwide recruitment approach, allowing participants from across the Netherlands to self-enroll via an open-access research website. After informed consent, 222 women will be randomly allocated to one of four conditions in a two-by-two treatment design: 1. MHT, 2. CBCTi, 3. MHT + CBCTi and 4. control. MHT consists of transdermal estradiol patches and progesterone tablets in standard doses. CBCTi addresses sleep and circadian behaviour and cognitive restructuring. The primary study outcome is the change in insomnia symptoms assessed with the Insomnia Severity Index (ISI) after 8 weeks (T1) and 15 weeks (T2) relative to baseline (T0). Secondary outcomes are other subjective sleep quality indicators, objective sleep estimated from actigraphy and headband EEG, changes in climacteric symptoms, hot flash frequency estimated from wrist electrodermal activity, other mental health complaints, and wellbeing and daytime functioning. Furthermore, baseline personal characteristics will be assessed, including the history of hormone-related mental health problems.

Discussion

This study addresses the gap in research regarding optimal treatment for insomnia during the perimenopause, and how treatments alleviate or prevent other mental health problems and climacteric symptoms including hot flashes. Trial Registration The study was prospectively registered in the National Library of Medicine on May 13th 2024 as ‘Improving Sleep and Mood in Peri-Menopause’ (NCT06306404, https://clinicaltrials.gov/study/NCT06306404?cond=NCT06306404&rank=1). Competing Interest Statement The authors have declared no competing interest. Clinical Trial NCT06306404 Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study has been approved by the Medical Research Ethics Committee of the Amsterdam University Medical Center (METC AUMC), and by the Institutional Review Boards of the participating sites. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability The data collected in this study will be available from the corresponding author upon reasonable request and after publication of findings.

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