Overview

The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are:

• 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.

Eligibility

Inclusion Criteria:

• Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
• 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:

• Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
• 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