Sleep-hygiene education to improve sleep quality and mood in menopausal women.
Official title: The Effect of Information, Motivation, Behavioral Skills (IMB) Model-Based Sleep Hygiene Education on Sleep Quality and Depression Level in Menopausal Women: A Methodological and Experimental Study
Run by Ankara Yildirim Beyazıt University · NCT07299903 · Data updated 2026-11-12
This trial will try sleep-hygiene education based on the IMB model to see if it improves sleep quality and reduces depressive symptoms in menopausal women with poor sleep.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 60 Years |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Ankara Yildirim Beyazıt University Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | March 1, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07299903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 40–60 who are in menopause, have low sleep quality on the menopause-specific scale, can use a smartphone/tablet/computer with internet, and do not have major psychiatric, neurologic, or chronic systemic illnesses or recent sleep-hygiene training.
✕Probably not a fit
Patients with diagnosed chronic psychiatric disorders, those currently treated for a sleep disorder, on hormone replacement therapy, with neurologic/systemic conditions affecting sleep, or without internet access are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study first develops a menopause-specific sleep quality scale, then randomizes eligible menopausal women to either an IMB-model sleep-hygiene education program or a control group. The intervention is delivered via online training and participants complete daily sleep logs to monitor adherence. Sleep quality and depressive symptoms are measured before and after the intervention using validated questionnaires and physiologic tracking where applicable. Results will show whether a targeted education program can change sleep behavior and mood in this population.
Why it matters
Potential benefit: If successful, the program could provide a low-cost, non-drug way to improve nighttime sleep and reduce depressive symptoms for menopausal women.
How similar studies have gone: Behavioral sleep-hygiene and cognitive-behavioral approaches have shown modest improvements in insomnia symptoms in prior research, but applying the IMB model specifically to menopausal sleep is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being in menopause * Being between 40 and 60 years of age * Having a low sleep quality score according to the Menopause-Specific Sleep Quality Scale. * Being willing to participate in the study. * Having no physical or mental disabilities that would hinder communication. * Having technology (smartphone, tablet, or computer) with internet access and the ability to participate in online training. Exclusion Criteria: * Having a history of receiving psychological support. * Having been diagnosed with a chronic psychiatric illness (previously diagnosed depression, anxiety disorder, etc.). * Having a neurological or chronic systemic illness that may affect sleep quality. * Being treated for a sleep disorder (receiving medication or psychotherapy). * Receiving hormone replacement therapy (HT). * Having received sleep hygiene training/therapy within the last 6 months.
Where it's running
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Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Busra Karagol
- Email: busrakaragol22@gmail.com
- Phone: +90 544 574 56 95
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.