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Sleep fix for depression? brain study tests CBT-I
NCT ID NCT06373718
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a proven sleep therapy (CBT-I) can improve how the brain regulates emotions, helping treat depression and anxiety. Researchers will use brain scans to see changes in emotion networks. 120 adults with insomnia and depression will participate. The goal is to understand if fixing sleep can ease depression symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and females of any racial or ethnic group, aged 18-65 * Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10) * Insomnia complaint ≥ 3 months in duration * Subjective complaint of depressive symptoms as defined by scores of ≥ 14 on the BDI * Fluent and literate in English * Written, informed consent * Reside within 60 miles of Stanford University Exclusion Criteria: * Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders * Use of psychotropic medications that would significantly impact sleep, alertness, or mood and unwilling or unable to discontinue medication specifically prescribed for sleep disturbance \> two weeks (anti-depressants) or \>1 week (sleep medications) prior to baseline data collection * Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion) * Presence of suicidal ideations representing imminent risk as determined by the empirically-supported, standardized suicide risk assessment * General medical condition, disease or neurological disorder that interferes with the assessments * Substance abuse or dependence * History of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities OR traumatic brain injury in the past two months * Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols * Pregnant or breast feeding * Current or lifetime history of bipolar disorder or psychosis * Current or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition * Received cognitive behavioral therapy for insomnia within the past year * Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months; unstable adult onset diabetes as defined by treatment regimen changes in the prior 3 months * Current exposure to trauma, or exposure to trauma within the past 3 months * Working a rotating shift that overlaps with 2400h * Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent or have untreated OSA of moderate severity or worse (AHI ≥ 15)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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