Targeting Insomnia to Prevent Depression in the Menopause Transition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: digital cognitive behavioral therapy for insomnia, Digital sleep hygiene education.
- Who it may be relevant to
- Registry conditions: Insomnia, Menopause Related Conditions. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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?
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.
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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07443644 · 2089409