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

NCT07431034 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rasool Hamidi Choolabi

    lead OTHER

Principal Investigators

  • Omid Amani, PhD · Department of Psychology, Shahid Beheshti University, Tehran, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-21
Primary Completion
2026-04-04
Completion
2026-08-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07431034 on ClinicalTrials.gov