Study Results
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Basic Information
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RECRUITING
PHASE4
54 participants
INTERVENTIONAL
2026-01-01
2027-01-30
Brief Summary
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* Are HRT and CBT-I effective in reducing insomnia in menopausal women?
* Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population?
Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions.
Participants will:
* Complete a screening and baseline assessment
* Receive Hormone Replacement Therapy (as prescribed), Cognitive Behavioral Therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks.
* Keep a daily diary (sleep e-diary), to assess sleep-quality.
* Wear an electroencephalogram (EEG) during 6 nights (3 at baseline \& 3 post-intervention), to assess deep sleep cycles and waking episodes.
* Receive a phone call for intervention compliance
* Complete a post-intervention assessment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive Behavioral Therapy for insomnia (CBT-I)
Participants in this experimental arm will receive cognitive behavioral therapy specifically designed to treat insomnia (CBT-I). The therapy will be delivered over 8 weekly sessions, each lasting 60 minutes. The sessions will include techniques such as sleep restriction, stimulus control, cognitive restructuring, and relaxation training. The primary goal is to improve sleep quality and reduce the severity of insomnia.
Cognitive Behavioural Therapy for Insomnia (CBT-I)
CBT-I is conducted in an individual setting according to the manual used in McCurry (1). Factors at the level of behavior, cognitions, and physiology that perpetuate sleep onset and sleep maintenance disorders are addressed. In addition, psychoeducation on sleep and sleep hygiene, stimulus control, sleep restriction, relaxation, structured worry time, cognitive restructuring, and relapse prevention are part of the training. Each session will include homework.
Hormone Replacement Therapy (HRT)
Participants in this experimental arm will receive hormone replacement therapy, specifically a combination of estrogen and progesterone over the course of 8 weeks. The therapy aims to alleviate menopausal symptoms, including insomnia, by addressing hormonal imbalances.
Hormone Replacement Therapy (HRT)
Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1 capsule of Utrogestan® 200). This combination is the most popular HRT regimen, as it has a neutral effect on lipids, glucose, haemostasis. Participants will receive a conventional prescription for the 2 products that are covered by all health insurances in Switzerland.
Sleep Hygiene
Participants in this sham comparator arm will receive sleep hygiene instructions. Instructions will be delivered over 8 weekly sessions. The instructions will provide general information about healthy sleep habits, such as food and drink choices, a regular sleep schedule, evening routine, etc. Although being widely used in daily clinical practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.
Sleep Hygiene
Sleep hygiene refers to healthy sleep habits, e.g. food and drink choices, a regular sleep schedule, evening routine. Although being widely used in daily practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.
Interventions
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Cognitive Behavioural Therapy for Insomnia (CBT-I)
CBT-I is conducted in an individual setting according to the manual used in McCurry (1). Factors at the level of behavior, cognitions, and physiology that perpetuate sleep onset and sleep maintenance disorders are addressed. In addition, psychoeducation on sleep and sleep hygiene, stimulus control, sleep restriction, relaxation, structured worry time, cognitive restructuring, and relapse prevention are part of the training. Each session will include homework.
Hormone Replacement Therapy (HRT)
Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1 capsule of Utrogestan® 200). This combination is the most popular HRT regimen, as it has a neutral effect on lipids, glucose, haemostasis. Participants will receive a conventional prescription for the 2 products that are covered by all health insurances in Switzerland.
Sleep Hygiene
Sleep hygiene refers to healthy sleep habits, e.g. food and drink choices, a regular sleep schedule, evening routine. Although being widely used in daily practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.
Eligibility Criteria
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Inclusion Criteria
* Pittsburgh Sleep Quality Index (PSQI) score \> 5
* Insomnia Severity Index (ISI) score \> 7
* Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
* Willingness to use HRT for menopausal symptom reliefs
Exclusion Criteria
* Untreated hormonal disorder
* Obesity (BMI ≥ 30)
* Current psychotherapy
* Current psychopharmacological therapy including regular sleep medication
* History of unsuccessful CBT-I
* Psychiatric illness
* Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)
* Shift work
* Long-haul flights across different time zones in the past 3 months
* Pregnancy and lactation
* Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/)
* Inability to follow procedures or insufficient knowledge of project language
* Inability to give consent
45 Years
69 Years
FEMALE
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Petra Stute, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Locations
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University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Petra Stute, Prof.
Role: primary
References
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Pavicic E, Stute P, Rudzik F, Urech A, Lozza-Fiacco S. No more sleepless nights in perimenopause-an open-label, randomized, parallel-group, active controlled intervention study in perimenopausal women with vasomotor symptoms and insomnia to investigate the efficacy of hormone replacement therapy and cognitive behavioral therapy for the treatment of insomnia: study protocol. Trials. 2025 Dec 30. doi: 10.1186/s13063-025-09366-9. Online ahead of print.
Other Identifiers
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2023-00209
Identifier Type: -
Identifier Source: org_study_id
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