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Can a brain zapping technique and online therapy fix sleep in depressed teens?

NCT ID NCT07807072

Disease control Sponsor: Central China Normal 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether combining an online form of Acceptance and Commitment Therapy with a noninvasive brain stimulation technique can improve sleep quality in adolescents with depression and sleep problems. About 160 teens aged 11 to 19 are randomly assigned to receive the combination, either treatment alone, or no active treatment. The study measures sleep quality, depressive symptoms, and psychological flexibility before, right after, and 30 days after the 12-day program.

What this could mean

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

Active substance
Internet-delivered Acceptance and Commitment Therapy combined with intermittent theta burst stimulation
What this could lead to
If effective, this combination could offer a non-drug approach to improve sleep and reduce depressive symptoms in adolescents.
What could go wrong
The trial is relatively small and early, and results may not apply broadly. Brain stimulation can cause headache or scalp discomfort, and the online therapy requires consistent participation.

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

160 people

The number who actually took part.

Started

Aug 2023

Finished

Jan 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

11 to 19 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: 1. Age 11 to 19 years. 2. A primary depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by independent evaluations conducted by two board-certified psychiatrists using semistructured clinical interviews. Any discrepancy was adjudicated by a senior psychiatrist. 3. Hamilton Depression Rating Scale, 17-item version (HAMD-17) score of at least 8. 4. Current subjective sleep disturbance, including difficulty initiating sleep, frequent nighttime awakenings, or nonrestorative sleep, confirmed during the diagnostic interview. 5. Either no antidepressant medication or stable antidepressant pharmacotherapy for at least 2 weeks before enrollment. 6. No concurrent systematic psychological or physical treatment during the study. 7. Right-handedness. 8. Written informed consent from a parent or legal guardian and written assent from the adolescent participant. Exclusion Criteria: 1. History of epilepsy, major neurological disorder, or any contraindication to transcranial magnetic stimulation, including relevant metal implants. 2. Acute suicide risk requiring immediate clinical intervention. 3. Substance use disorder within the previous year. 4. Severe somatic illness that could interfere with study participation or outcome assessment. 5. Current use of targeted hypnotic or sedative medication.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder Parasomnias sleep disorder

As listed by the trial registrant

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

Depressive disorder Sleep disturbance

Contacts and locations

Locations

  • Anhui Mental Health Center

    Wuhan, Hubei, 430079, China

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