An interventional study of digital cognitive behavioral therapy for insomnia and Digital sleep hygiene education in Insomnia and Menopause Related Conditions, sponsored by SRI International. Not yet recruiting. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by SRI International · Not applicable, Interventional, and Treatment
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:
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 230 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →SRI International is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
An automated digital CBT-I program, delivered in 6 modules at least one week apart.
Behavioral: digital cognitive behavioral therapy for insomnia
A digital sleep hygiene intervention delivered in 6 modules, at least one week apart.
Behavioral: Digital sleep hygiene education
A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy
Also known as: dCBT-I
A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.
Depressive symptom severity (PHQ-9 score)
Time frame: Baseline and every 3 months post randomization for 2 years
Insomnia severity index (ISI)
Score on the insomnia severity index
Time frame: Baseline and every 3 months post-randomization for 2 years
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2031, 53 months later.
Of 78 industry-sponsored interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 53 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →
SRI International