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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
digital cognitive behavioral therapy for insomnia
BehavioralA digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy
Digital sleep hygiene education
BehavioralA digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Digital cognitive behavioral therapy for insomniaExperimental treatment 1 intervention
Group B: Digital sleep hygiene educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depressive symptom severity (PHQ-9 score)
Time frame
Baseline and every 3 months post randomization for 2 years2
Insomnia severity index (ISI)
Score on the insomnia severity index
Time frame
Baseline and every 3 months post-randomization for 2 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SRI International
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: