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Targeting Insomnia to Prevent Depression in the Menopause Transition

NCT07443644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-03-02

No results posted yet for this study

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.

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?

Conditions

Interventions

BEHAVIORAL

digital cognitive behavioral therapy for insomnia

A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy

BEHAVIORAL

Digital sleep hygiene education

A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-02-28
Completion
2031-02-28

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443644 on ClinicalTrials.gov