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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
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 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.
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland
RECRUITINGReduction of Insomnia Severity
Change from baseline in Insomnia Severity Index (ISI). The ISI is a seven-item questionnaire, asking respondents to rate the severity of sleep-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 28, where 0 indicates no presence of sleep-related symptoms and 28 indicates very severe symptoms.
Time frame: Week 10
Improvement in Climacteric Syndrome
Change from baseline in Menopause Rating Scale (MRS-II) The MRS-II is an eleven-item questionnaire, asking respondents to rate the severity of climcteric syndrome-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 44, where 0 indicates no presence of symptoms and 44 indicates very severe symptoms.
Time frame: Week 10
Changes in bio-functional age
Change from baseline in biofunctional status (i.e. differences between chronological age and biofunctional age).
Time frame: Week 10
Changes in maladaptive sleep-related cognitions
Change from baseline in Dysfunctional Attitudes and Beliefs about Sleep Scale (DBAS). The DBAS is a sixteen-item questionnaire, asking respondents to rate their attitudes/beliefs about sleep on 10-point numerical rating-scales (discrete intervals), ranging between 0 (I do not agree at all) and 10 (I agree completely). Total values may range between 0 and 160, where 0 indicates no presence of dysfunctional attitudes and 160 indicates very severe levels of maladaptive sleep-related cognitions.
Time frame: Week 10
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