Targeting Insomnia to Prevent Depression in the Menopause Transition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorSRI International
About this trial
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:
1. Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation? 2. Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- digital cognitive behavioral therapy for insomnia
- Digital sleep hygiene education
Treatment groups
230 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
SRI International
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov