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

NCT07431034 | Active Not Recruiting

• 1 other identifier: ICBTI-GEN
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia Disorder; Chronic Insomnia

Keywords

Insomnia; Sleep Disorders; Cognitive Behavioral Therapy for Insomnia; CBT-I; Internet-based Intervention; Digital Therapeutics; Web-based CBT; Persian-speaking Adults; Omid Program

Outcome Measures

Primary Outcomes (4)

• Insomnia Severity (Insomnia Severity Index, ISI)

  Change in insomnia severity as measured by the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing difficulty falling asleep, staying asleep, early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, perceived noticeability of sleep problem, and level of distress/worry about sleep. Each item is scored 0-4, total scores range 0-28, higher scores indicate greater insomnia severity. Score interpretation: 0-7 = no clinically significant insomnia, 8-14 = subthreshold insomnia, 15-21 = moderate clinical insomnia, 22-28 = severe clinical insomnia.

  Baseline (Day 0), post-intervention (Day 30), follow-up (3 months post-intervention, Day 120).

• Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

  Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI), an 18-item self-report questionnaire assessing 7 components of sleep: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored 0-3, total scores range 0-21, higher scores indicate poorer sleep quality. A total score \>5 indicates poor sleep quality.

  Baseline (Day 0), post-intervention (Day 30), follow-up (3 months post-intervention, Day 120).

• Pre-Sleep Arousal (Pre-Sleep Arousal Scale, PSAS)

  Change in pre-sleep arousal as measured by the Pre-Sleep Arousal Scale (PSAS), a 16-item self-report questionnaire assessing somatic (questions 1-8) and cognitive (questions 9-16) arousal prior to sleep. Items are rated 1-5; total scores range 16-80, higher scores indicate greater pre-sleep arousal and higher risk of sleep disturbance. Score interpretation: 16-32 = low, 33-48 = moderate, \>48 = high pre-sleep arousal.

  Baseline (Day 0), post-intervention (Day 30), follow-up (3 months post-intervention, Day 120).

• Dysfunctional Beliefs and Attitudes about Sleep (DBAS-10)

  Change in dysfunctional beliefs and attitudes about sleep as measured by the DBAS-10, a 10-item self-report questionnaire assessing maladaptive cognitions and attitudes regarding sleep. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). Total scores range 10-50, higher scores indicate more dysfunctional beliefs and attitudes about sleep, which are associated with greater insomnia severity.

  Baseline (Day 0), post-intervention (Day 30), follow-up (3 months post-intervention, Day 120).

Study Arms (2)

Omid ICBT-I

EXPERIMENTAL

Participants in this arm will receive access to the Omid Persian-language internet-based cognitive behavioral therapy for insomnia (ICBT-I) program, consisting of weekly web-based modules with psychoeducation about sleep, sleep hygiene, stimulus control, sleep restriction, and cognitive techniques.

Behavioral: Omid Internet-Based CBT-I Program

Wait-list Control

NO INTERVENTION

Participants in this arm will remain on a wait-list and receive usual care during the study period. They will be offered access to the Omid ICBT-I program after completion of the final follow-up assessments.

Interventions

Omid Internet-Based CBT-I Program BEHAVIORAL

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.

Omid ICBT-I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rasool Hamidi Choolabi: lead

Study Sites (1)

Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Related Links

• Official website of the Omid internet-based CBT-I program

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Omid Amani, PhD

  Department of Psychology, Shahid Beheshti University, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychologist and Investigator

Model Details: Two-arm parallel-group randomized controlled trial with a web-based CBT-I intervention (Omid) versus wait-list control.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 24, 2026
• Study Start: February 21, 2026
• Primary Completion: April 4, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

IR (1)