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New Web-Based therapy aims to cure insomnia in persian speakers

NCT ID NCT07431034

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tested whether a Persian-language internet program called Omid, based on cognitive behavioral therapy, can improve sleep in adults with insomnia. Thirty participants were randomly assigned to use the program or receive usual care. The program includes weekly online lessons and a sleep diary. Researchers measured changes in insomnia severity, sleep quality, and daytime sleepiness.

What this could mean

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

Active substance
Omid internet-based cognitive behavioral therapy for insomnia (ICBT-I) program
What this could lead to
If it works, this could offer a convenient, accessible treatment option for Persian-speaking adults with insomnia, potentially reducing reliance on sleep medications.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply to everyone. The control group receives no active treatment, and the program's effectiveness may depend on user engagement.

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

30 people

The number who actually took part.

Started

Feb 2026

Finished

May 2026

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 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: * Age between 18 and 60 years. * Meets diagnostic criteria for insomnia disorder according to DSM-5, based on clinical interview or a validated screening procedure. * Insomnia Severity Index (ISI) score ≥ 10, indicating at least subthreshold insomnia. * Reports difficulty initiating or maintaining sleep or early-morning awakenings at least three nights per week for at least three months, with associated daytime impairment (e.g., fatigue, concentration problems, irritability). * Able to read and understand Persian. * Has regular access to the internet and a smartphone and/or computer to use the Omid web-based program. * Willing and able to provide informed consent and to complete online questionnaires and daily sleep diaries. Exclusion Criteria: * Uncontrolled medical or neurological conditions that significantly interfere with sleep or require immediate treatment (e.g., untreated moderate-to-severe obstructive sleep apnea, uncontrolled epilepsy, unstable cardiac disease, advanced cancer). * Current shift work or rotating work schedules that regularly disrupt nighttime sleep. * Pregnancy. * Participation in another clinical trial or research study that could affect sleep during the study period. * Ongoing structured psychotherapy specifically targeting insomnia or other major psychiatric conditions within the past 6 months. * Current major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, psychotic disorders), as determined by clinical assessment or structured interview. * Evidence of problematic substance use, such as heavy alcohol use (more than approximately 3 standard drinks per day on most days of the month) or frequent misuse of recreational drugs (e.g., cannabis use more than once per week), in the judgment of the investigators. * Active suicidal ideation or behavior requiring urgent clinical intervention. * Primary diagnosis of another untreated sleep disorder (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorder) where insomnia is not the main problem. * Having an infant or child under 2 years of age whose care regularly disrupts nighttime sleep, in the judgment of the investigators.

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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.

Contacts and locations

Locations

  • Shahid Beheshti University of Medical Sciences

    Tehran, Iran

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