InsomniaNCT07299903
IMB-Based Sleep Hygiene Education for Menopausal Women: Effects on Sleep Quality and Depression
A study testing Sleep Hygiene Education in people with Insomnia and Depressive Symptoms, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in women during menopause. Women will be randomly assigned to either an education group or a control group. The education group will receive training based on the Information-Motivation-Behavioral Skills (IMB) Model. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Insomnia, Depressive Symptoms
- What is being tested?
- Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara
Ankara Atatürk Sanatorium Training and Research Hospital, +90 544 574 56 95, busrakaragol22@gmail.com
Aytebn ARIÖZ DÜZGÜN
About this study
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
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in women during menopause. Women will be randomly assigned to either an education group or a control group. The education group will receive training based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the education. The results will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression in menopausal women.
Read the detailed description
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in menopausal women. The study will be conducted in two phases. In the first phase, a menopause-specific sleep quality scale will be developed to assess sleep habits, nighttime awakenings, sleep disruptors, and sleep hygiene behaviors in this population. In the second phase, participants will be randomly assigned to either a control group or an intervention group receiving sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the intervention using validated psychological and physiological assessments. Daily sleep tracking logs will also be used to monitor adherence and intervention effectiveness. The findings will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression among menopausal women, and will serve as a resource for developing nursing interventions and informing health policies.
- Conditions
- Insomnia, Depressive Symptoms
- Being tested
- Sleep Hygiene Education
- Keywords
- Menopause, Sleep quality, Sleep hygiene, Depression, Women's health, Randomized controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education | Experimental | Participants will receive sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep habits, routines, and behaviors to improve sleep quality will be taught. Sleep quality and depression will be measured before and after the intervention, and participants will maintain daily sleep logs. Receives: Behavioral: Sleep Hygiene Education |
| Control | No intervention | Participants will receive standard care without additional sleep hygiene education. Sleep quality and depression will be measured at the same time points as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Change in sleep quality measured using the Menopause-Specific Sleep Quality Scale before and after the sleep hygiene education intervention.
Measured: Baseline and 10 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayten ARIÖZ DÜZGÜN, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299903
- Sponsor's protocol ID
- 20.11.2025-09/1541
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD Sharing Plan: Yes. De-identified IPD (protocol, SAP, and raw outcome datasets for MSSQS and BDI) will be shared with researchers submitting a methodologically sound proposal. Data will be available starting 9 months post-publication and for 36 months. Access requires a signed Data Access Agreement (DAA). Contact the Principal Investigator at \[busrakaragol22@gmail.com\] for proposals.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07299903
- Acronym / sponsor ID
- 20.11.2025-09/1541
- Conditions
- Insomnia, Depressive Symptoms
- Keywords
- Menopause, Sleep quality, Sleep hygiene, Depression, Women's health, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in women during menopause. Women will be randomly assigned to either an education group or a control group. The education group will receive training based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the education. The results will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression in menopausal women.
Detailed description
This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in menopausal women. The study will be conducted in two phases. In the first phase, a menopause-specific sleep quality scale will be developed to assess sleep habits, nighttime awakenings, sleep disruptors, and sleep hygiene behaviors in this population. In the second phase, participants will be randomly assigned to either a control group or an intervention group receiving sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the intervention using validated psychological and physiological assessments. Daily sleep tracking logs will also be used to monitor adherence and intervention effectiveness. The findings will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression among menopausal women, and will serve as a resource for developing nursing interventions and informing health policies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education | Experimental | Behavioral: Sleep Hygiene EducationParticipants will receive sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep habits, routines, and behaviors to improve sleep quality will be taught. Sleep quality and depression will be measured before and after the intervention, and participants will maintain daily sleep logs. |
| Control | No intervention | –Participants will receive standard care without additional sleep hygiene education. Sleep quality and depression will be measured at the same time points as the intervention group. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene EducationEducation based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality. | Behavioural | Sleep Hygiene Education |
Primary outcome
Sleep Quality
Time frame: Baseline and 10 weeks after intervention
Change in sleep quality measured using the Menopause-Specific Sleep Quality Scale before and after the sleep hygiene education intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. IPD Sharing Plan: Yes. De-identified IPD (protocol, SAP, and raw outcome datasets for MSSQS and BDI) will be shared with researchers submitting a methodologically sound proposal. Data will be available starting 9 months post-publication and for 36 months. Access requires a signed Data Access Agreement (DAA). Contact the Principal Investigator at [busrakaragol22@gmail.com] for proposals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayten ARIÖZ DÜZGÜN study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education in people with Insomnia and Depressive Symptoms, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Busra Karagol (+90 544 574 56 95, busrakaragol22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Baseline and 10 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.