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?

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Key information

Conditions

Insomnia Dyssomnias Hot Flashes Menopause Related Conditions Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

digital cognitive behavioral therapy for insomnia

Behavioral

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

Other names: dCBT-I

Digital sleep hygiene education

Behavioral

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

Primary outcomes

Depressive symptom severity (PHQ-9 score)

Time frame: Baseline and every 3 months post randomization for 2 years
Insomnia severity index (ISI)

Time frame: Baseline and every 3 months post-randomization for 2 years

Score on the insomnia severity index

Sponsors and collaborators

Lead sponsor

SRI International

Industry

Collaborators

Stanford University

Registry information

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Mar 2, 2026
Registry last updated: Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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