Clinical Trial

Internet-Based Cognitive Behavioral Therapy for Insomnia in Persian-Speaking Adults

Study acronym: ICBT-I
Completed
View on ClinicalTrials.gov →
Summary
This study will test whether an internet-based cognitive behavioral therapy for insomnia (ICBT-I) delivered through the Persian-language web program "Omid" can improve sleep in Persian-speaking adults with insomnia. Participants will be adults who have problems falling or staying asleep and meet diagnostic criteria for insomnia. Those who are eligible will be randomly assigned to either receive access to the Omid web-based CBT-I program or to a wait-list control group that will receive usual care during the study period. The Omid program provides weekly online modules with educational videos and texts about sleep and insomnia, sleep hygiene, stimulus control, sleep restriction, and cognitive techniques to manage unhelpful thoughts about sleep. Participants will complete questionnaires about insomnia severity, sleep quality, and daytime sleepiness before starting the program, after finishing the intervention, and at follow-up. The main goal is to see whether the Omid ICBT-I program reduces insomnia symptoms and improves overall sleep quality compared with the wait-list control group.
Protocol Amendment History 5 changes
critical Trial completed 2026-05-29
notable Enrollment reduced: 200 -> 30 participants 2026-05-29
minor Completion moved earlier: 2026-08 -> 2026-05-04 2026-05-29
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-04-25
notable Primary completion moved earlier: 2026-07 -> 2026-04-04 2026-04-25
Trial Details
NCT Number NCT07431034
Lead Sponsor Rasool Hamidi Choolabi
Conditions Insomnia Disorder, Chronic Insomnia
Enrollment 30 participants
Start Date 2026-02-21
Primary Completion 2026-04-04 (estimated)
Study Completion 2026-05-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-28