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Sleep therapy may rewire brain to fight depression

NCT ID NCT04424407

Symptom relief Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a sleep therapy called CBT-I could reduce depression and anxiety by improving how the brain controls emotions. 51 adults with poor sleep and depression symptoms took part. They met with a psychologist weekly for six weeks to learn better sleep habits. The researchers used brain scans to see if the therapy changed emotion-related brain activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If it works, this could point toward a drug-free way to ease depression and anxiety by fixing sleep and the brain's emotion control.
What could go wrong
This is a small, early study (51 people) with no control group, so results may not apply broadly. The main goal was to measure brain changes, not prove a treatment works.

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

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

51 people

The number who actually took part.

Started

May 2021

Finished

Mar 2024

Lead sponsor

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

25 to 60 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ages 25-60 * Subjective complaint of sleep disturbance for ≥ 3 months (ISI≥10) * Subjective complaint of depression (BDI≥14) and not at imminent risk for suicide, as measured by CSSRS assessment * 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 * Medications that would significantly impact sleep, alertness, or mood * \>14 alcoholic drinks per week or \>4 drinks per occasion * General medical condition, disease or neurological disorder that interferes with the assessments or outpatient participation * Substance abuse or dependence * Mild traumatic brain injury * Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols * Pregnant or breast feeding * Current or lifetime history of bipolar disorder or psychosis * Current or or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition * Received CBT-I within the past year * Acute or unstable chronic illness * Current exposure to trauma, or exposure to trauma within the past 3 months * Working a rotating shift that overlaps with 2400h. * Presence of suicidal ideations representing imminent risk as determined by the empirically-supported, standardized suicide risk assessment" to the exclusion criteria * Individuals who 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.

anxiety disorder Depression depressive disorder insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Insomnia

Contacts and locations

Locations

  • Stanford University

    Palo Alto, California, 94304, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.