Targeting Insomnia to Prevent Depression in the Menopause Transition

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Menopause Related Conditions
• Intervention / Treatment: Behavioral: digital cognitive behavioral therapy for insomnia; Behavioral: Digital sleep hygiene education

Detailed Description

Insomnia is a common problem for women in perimenopause. Previous research found that insomnia predicts future development of depression and suggests that treating insomnia can lead to improvement in mood. This study will investigate the long-term effects of treating insomnia with two different interventions on depression among perimenopausal individuals. The two interventions are, digital cognitive behavioral therapy for insomnia (dCBT-I), which has been proven effective, and sleep hygiene intervetion (SHI), which is in common use in general practice.

Participants will be screened for eligibility. Those eligible will be randomized to one of the two treatment arms (dCBT-I or SHI) and complete assessments at 3-month intervals across a 2-year period. Assessments will include questionnaires, clinical interviews, and using a wearable device. All assessments will be done remotely.

Aim 1: To determine if dCBT-I in the menopause transition prospectively prevents depressive symptoms and improves menopause-specific quality of life.

Aim 2: To determine whether the effect of dCBT-I on depressive symptoms is mediated through improving insomnia symptom severity (primary) and secondarily, reducing wakefulness after sleep onset in the menopause transition.

The study will also explore pathways linking dCBT-I and prevention of depressive symptoms.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 40 years old and in the perimenopause,
2. Willingness to participate in a digital research protocol,
3. Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause,
4. English fluency.

Exclusion Criteria:

1. Current major depressive disorder
2. Existing diagnosis of a sleep disorder other than insomnia
3. Experiencing excessive daytime sleepiness
4. Having received CBT-I in the preceding 6 months
5. Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims
6. Hysterectomy and/or bilateral ovariectomy or current hormonal therapy,
7. Night shift worker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital cognitive behavioral therapy for insomnia; An automated digital CBT-I program, delivered in 6 modules at least one week apart.	Behavioral: digital cognitive behavioral therapy for insomnia; A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy; Other Names: dCBT-I
Active Comparator: Digital sleep hygiene education; A digital sleep hygiene intervention delivered in 6 modules, at least one week apart.	Behavioral: Digital sleep hygiene education; A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SRI International
• Collaborators: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: menopause; insomnia; hot flashes; cognitive behavioral therapy for insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Hot Flashes
• Other Study ID Numbers: 2089409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No