Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBT-I) | Experimental | 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. |
|
| Hormone Replacement Therapy (HRT) | Active Comparator | 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. |
|
| Sleep Hygiene | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy for Insomnia (CBT-I) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction 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. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Stute, Prof. | Contact | +41 31 632 1010 | petra.stute@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Petra Stute, Prof. | University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41462320 | Derived | 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;27(1):94. doi: 10.1186/s13063-025-09366-9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004358 | Drug Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hormone Replacement Therapy (HRT) | Drug | 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 | Behavioral | 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. |
|
| Week 10 |
| Changes in bio-functional age | Change from baseline in biofunctional status (i.e. differences between chronological age and biofunctional age). | 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. | Week 10 |
| D001523 |
| Mental Disorders |
| D013812 |
| Therapeutics |