InsomniaNCT07443644
Targeting Insomnia to Prevent Depression in the Menopause Transition
A study testing digital cognitive behavioral therapy for insomnia and Digital sleep hygiene education in people with Insomnia and Menopause Related Conditions, run by SRI International.
Trial summary
This randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Insomnia, Menopause Related Conditions
- What is being tested?
- digital cognitive behavioral therapy for insomnia and Digital sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2031
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 40 years old and in the perimenopause,
- Willingness to participate in a digital research protocol,
- Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause,
- English fluency.
Who cannot join
- Current major depressive disorder
- Existing diagnosis of a sleep disorder other than insomnia
- Experiencing excessive daytime sleepiness
- Having received CBT-I in the preceding 6 months
- Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims
- Hysterectomy and/or bilateral ovariectomy or current hormonal therapy,
- Night shift worker
About this study
This randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period.
The two main questions the study aims to answer are:
- Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation?
- Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?
Read the detailed description
Insomnia is a common problem for women in perimenopause. Previous research found that insomnia predicts future development of depression and suggests that treating insomnia can lead to improvement in mood. This study will investigate the long-term effects of treating insomnia with two different interventions on depression among perimenopausal individuals. The two interventions are, digital cognitive behavioral therapy for insomnia (dCBT-I), which has been proven effective, and sleep hygiene intervetion (SHI), which is in common use in general practice.
Participants will be screened for eligibility. Those eligible will be randomized to one of the two treatment arms (dCBT-I or SHI) and complete assessments at 3-month intervals across a 2-year period. Assessments will include questionnaires, clinical interviews, and using a wearable device. All assessments will be done remotely.
Aim 1: To determine if dCBT-I in the menopause transition prospectively prevents depressive symptoms and improves menopause-specific quality of life.
Aim 2: To determine whether the effect of dCBT-I on depressive symptoms is mediated through improving insomnia symptom severity (primary) and secondarily, reducing wakefulness after sleep onset in the menopause transition.
The study will also explore pathways linking dCBT-I and prevention of depressive symptoms.
- Conditions
- Insomnia, Menopause Related Conditions
- Being tested
- digital cognitive behavioral therapy for insomnia, Digital sleep hygiene education
- Keywords
- menopause, hot flashes, cognitive behavioral therapy for insomnia, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital cognitive behavioral therapy for insomniaBehavioural
Also called dCBT-I
A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy
Digital sleep hygiene educationBehavioural
A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.
| Study group | Role | What they receive |
|---|---|---|
| Digital cognitive behavioral therapy for insomnia | Experimental | An automated digital CBT-I program, delivered in 6 modules at least one week apart. Receives: Behavioral: digital cognitive behavioral therapy for insomnia |
| Digital sleep hygiene education | Active comparator | A digital sleep hygiene intervention delivered in 6 modules, at least one week apart. Receives: Behavioral: Digital sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom severity (PHQ-9 score)
Measured: Baseline and every 3 months post randomization for 2 years
Insomnia severity index (ISI)
Score on the insomnia severity index
Measured: Baseline and every 3 months post-randomization for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443644
- Sponsor's protocol ID
- 2089409
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Insomnia to Prevent Depression in the Menopause Transition
- ClinicalTrials.gov ID
- NCT07443644
- Acronym / sponsor ID
- 2089409
- Conditions
- Insomnia, Menopause Related Conditions
- Keywords
- menopause, hot flashes, cognitive behavioral therapy for insomnia, insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 2 Mar 2026 (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 randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period.
The two main questions the study aims to answer are:
- Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation?
- Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?
Detailed description
Insomnia is a common problem for women in perimenopause. Previous research found that insomnia predicts future development of depression and suggests that treating insomnia can lead to improvement in mood. This study will investigate the long-term effects of treating insomnia with two different interventions on depression among perimenopausal individuals. The two interventions are, digital cognitive behavioral therapy for insomnia (dCBT-I), which has been proven effective, and sleep hygiene intervetion (SHI), which is in common use in general practice.
Participants will be screened for eligibility. Those eligible will be randomized to one of the two treatment arms (dCBT-I or SHI) and complete assessments at 3-month intervals across a 2-year period. Assessments will include questionnaires, clinical interviews, and using a wearable device. All assessments will be done remotely.
Aim 1: To determine if dCBT-I in the menopause transition prospectively prevents depressive symptoms and improves menopause-specific quality of life.
Aim 2: To determine whether the effect of dCBT-I on depressive symptoms is mediated through improving insomnia symptom severity (primary) and secondarily, reducing wakefulness after sleep onset in the menopause transition.
The study will also explore pathways linking dCBT-I and prevention of depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital cognitive behavioral therapy for insomnia | Experimental | Behavioral: digital cognitive behavioral therapy for insomniaAn automated digital CBT-I program, delivered in 6 modules at least one week apart. |
| Digital sleep hygiene education | Active comparator | Behavioral: Digital sleep hygiene educationA digital sleep hygiene intervention delivered in 6 modules, at least one week apart. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 40 years old and in the perimenopause,
- Willingness to participate in a digital research protocol,
- Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause,
- English fluency.
Key exclusion criteria (7 listed)
- Current major depressive disorder
- Existing diagnosis of a sleep disorder other than insomnia
- Experiencing excessive daytime sleepiness
- Having received CBT-I in the preceding 6 months
- Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims
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 |
|---|---|---|
| digital cognitive behavioral therapy for insomniaAlso: dCBT-IA digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy | Behavioural | Digital cognitive behavioral therapy for insomnia |
| Digital sleep hygiene educationA digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep. | Behavioural | Digital sleep hygiene education |
Primary outcome
Depressive symptom severity (PHQ-9 score)
Time frame: Baseline and every 3 months post randomization for 2 years
Insomnia severity index (ISI)
Time frame: Baseline and every 3 months post-randomization for 2 years
Score on the insomnia severity index
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing digital cognitive behavioral therapy for insomnia and Digital sleep hygiene education in people with Insomnia and Menopause Related Conditions, run by SRI International.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom severity (PHQ-9 score) (time frame: Baseline and every 3 months post randomization for 2 years). The study lists 2 primary outcomes in all. 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 2 Mar 2026.