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NCT07431034

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

Sponsor: Rasool Hamidi Choolabi

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.

Official title: Evaluation of the Effectiveness of an Internet-Based Cognitive Behavioral Intervention on Sleep Quality, Insomnia Severity, and Daytime Sleepiness in Persian-Speaking Adults With Insomnia

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-03

Completion Date

2026-08

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Insomnia Disorder Chronic Insomnia

Interventions

BEHAVIORAL

Omid Internet-Based CBT-I Program

Omid is a Persian-language, semi-guided, web-based cognitive behavioral therapy for insomnia (ICBT-I) program designed for Persian-speaking adults with insomnia. The program is delivered via a secure web platform accessible on computers and smartphones and consists of six weekly structured sessions. Each session includes brief educational videos and texts, interactive exercises, and a daily sleep diary. Core components are based on the three-factor model of insomnia and CBT-I principles, and include sleep hygiene, stimulus control, sleep restriction, worry management, cognitive restructuring of unhelpful beliefs about sleep, and relapse prevention. Optional adjunct modules provide relaxation and mindfulness audio exercises and additional psychoeducational articles to support self-management and adherence.

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.

Locations (1)

Shahid Beheshti University of Medical Sciences

Tehran, Iran