Targeting Insomnia to Prevent Depression in the Menopause Transition

Sponsor
SRI International
Study ID
NCT07443644
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • digital cognitive behavioral therapy for insomnia — BEHAVIORAL
    A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy
  • Digital sleep hygiene education — BEHAVIORAL
    A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.

Study Details

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?

Key Dates

Start date
Sep 30, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital cognitive behavioral therapy for insomnia
    An automated digital CBT-I program, delivered in 6 modules at least one week apart.
  • Active Comparator: Digital sleep hygiene education
    A digital sleep hygiene intervention delivered in 6 modules, at least one week apart.

Primary Outcome Measure

Depressive symptom severity (PHQ-9 score) [ Time Frame: Baseline and every 3 months post randomization for 2 years ]

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