Targeting Insomnia to Prevent Depression in the Menopause Transition

NCT07443644 | Not Yet Recruiting

• 1 other identifier: 2089409
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation?
2. 2.Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?

Conditions

Insomnia; Menopause Related Conditions

Keywords

menopause; hot flashes; cognitive behavioral therapy for insomnia; insomnia

Outcome Measures

Primary Outcomes (2)

• Depressive symptom severity (PHQ-9 score)

  Baseline and every 3 months post randomization for 2 years

• Insomnia severity index (ISI)

  Score on the insomnia severity index

  Baseline and every 3 months post-randomization for 2 years

Study Arms (2)

Digital cognitive behavioral therapy for insomnia

EXPERIMENTAL

An automated digital CBT-I program, delivered in 6 modules at least one week apart.

Behavioral: digital cognitive behavioral therapy for insomnia

Digital sleep hygiene education

ACTIVE COMPARATOR

A digital sleep hygiene intervention delivered in 6 modules, at least one week apart.

Behavioral: Digital sleep hygiene education

Interventions

digital cognitive behavioral therapy for insomnia BEHAVIORAL

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

Also known as: dCBT-I

Digital cognitive behavioral therapy for insomnia

Digital sleep hygiene education BEHAVIORAL

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

Digital sleep hygiene education

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims
• Hysterectomy and/or bilateral ovariectomy or current hormonal therapy,
• Night shift worker

Sponsors & Collaborators

• SRI International: lead
• Stanford University: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hot Flashes

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share