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Can a website cure your sleepless nights? new study tests online insomnia therapy

NCT ID NCT04300218

Symptom relief Sponsor: I.M. Sechenov First Moscow State Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether an internet-based cognitive-behavioral therapy program (iCBT-I) can help people with chronic insomnia. 107 adults were randomly assigned to receive the online program or usual care. The program included educational videos, sleep tracking, and techniques like sleep restriction and relaxation. Researchers measured changes in insomnia severity and sleep quality to see if the online approach is effective and cost-effective.

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 cognitive-behavioral therapy for insomnia (iCBT-I)
What this could lead to
If successful, this could provide an effective, low-cost treatment option for chronic insomnia that people can access from home.
What could go wrong
This is a completed trial with 107 participants, so results may not apply to everyone. The therapy requires active participation and may not work for all types of insomnia.

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

107 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2023

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

18 to 80 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: * Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement * Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report Exclusion Criteria: * Presence of dementia (identified by history or a score \< 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement * Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score \> 28 ) and the Beck Anxiety Inventory (BAI; score \> 26) - assessed by the questionnaires * History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history * Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) \> 15), restless legs syndrome (movement index with arousal \> 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history * pregnancy, lactation - assessed by self-report * having a serious somatic condition or brain disorders (stroke, Parkinson's disease…) preventing further participation - assessed by self-report * Having high suicidality risk - assessed by clinical judgement, high total BDI-II score (\> 29) or score \>1 on a BDI-II of suicidality subscale

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

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

Chronic insomnia

Contacts and locations

Locations

  • Kuzbass clinical veterans hospital

    Kemerovo, Russia

  • Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University

    Moscow, Moscow, 119021, Russia

  • Stavropol regional somnological center

    Stavropol, Stavropol Kray, Russia

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