Home›Psychiatry› MHT and CBCTi trial protocol evaluates insomnia treatment in perimenopausal women
MHT and CBCTi trial protocol evaluates insomnia treatment in perimenopausal womenNew trial plans to test hormone therapy for menopause insomnia
medRxivPublished July 24, 2026Study authors: van Baarzel, F.; Broekman, B. F. P.; van Dijken, D.; MenoPause Consortium, ; van Someren, E.; Konin…DOI ↗Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain
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Key Takeaway
Note that no results are available as this trial is currently only a protocol.
This randomized controlled trial protocol describes an investigation into the management of insomnia and climacteric symptoms in perimenopausal women. The study aims to recruit 222 participants through web-based, nationwide recruitment in the Netherlands.
The study compares three intervention arms: MHT (transdermal estradiol patches and progesterone tablets), CBCTi (cognitive behavioural and circadian therapy for insomnia), and a combination of MHT plus CBCTi. A control group is also included in the trial design.
The primary outcome is the change in insomnia symptoms measured by the Insomnia Severity Index at 8 weeks (T1) and 15 weeks (T2) relative to baseline (T0). Secondary outcomes include subjective sleep quality, objective sleep via actigraphy and headband EEG, climacteric symptoms, hot flash frequency, mental health complaints, wellbeing, and daytime functioning.
No results are available as the study is currently a protocol. Safety data, including adverse events and tolerability, were not reported. This trial will evaluate whether adding MHT to CBCTi provides additional benefits for insomnia in this specific population.
How this fits prior evidence
How this fits prior evidence: This trial addresses a gap regarding the management of insomnia specifically during the menopausal transition. While previous coverage noted that CBT-I doubles absolute insomnia remission compared with sleep hygiene, and that exercise combined with CBT is the most consistently supported intervention for improving subjective sleep quality in insomnia, this study will evaluate if adding MHT to CBCTi provides specific benefits for perimenopausal women.
Many women experience sleepless nights as they move through the menopausal transition. This phase of life often brings physical changes and sleep struggles that can impact daily life. A new study in the Netherlands is designed to see if a combination of treatments can help.
The trial will involve 222 women who deal with both insomnia and symptoms related to menopause. Researchers plan to test three different approaches: hormone therapy alone, a specific behavioral and circadian therapy for insomnia (CBCTi), or a combination of both hormone therapy and the behavioral treatment.
Because this is currently a study protocol, no results have been gathered yet. The researchers will track changes in sleep quality over 15 weeks using tools like headbands to monitor brain waves and wearable devices to track hot flashes. While we do not know if these treatments work yet, the trial aims to provide clear data on how to better manage sleep during this life stage.
What this means for you:
A new study will test if combining hormone therapy with behavioral techniques improves sleep for menopausal women.
Common questions
What treatments are being tested for sleep?
The study plans to test three different approaches: hormone therapy (MHT) using patches and tablets, a cognitive behavioral and circadian therapy for insomnia (CBCTi), and a combination of both MHT and CBCTi. These methods aim to address the specific challenges of sleeping during the menopausal transition.
Who is eligible for this study?
The trial is designed for 222 women who are in the perimenopausal stage and experience both insomnia and climacteric symptoms, which are physical changes related to menopause like hot flashes.
Are there any results available yet?
No results are available yet because this is a study protocol. The researchers have designed the plan for the trial but have not yet completed the testing or gathered data on how effective these treatments are.
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).
