Rumination-Tailored Guided Internet-Based CBT-I for University Students (NCT07623889) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Rumination-Tailored Guided Internet-Based CBT-I for University Students
70 participantsStarted 2026-06
Plain-language summary
The goal of this clinical trial is to evaluate whether adding rumination-tailored, rule-based personalized feedback to guided internet-based cognitive behavioral therapy for insomnia (iCBT-I) improves treatment outcomes in university students with insomnia symptoms.
The main questions it aims to answer are:
Does rumination-tailored feedback improve insomnia severity compared to standard guided iCBT-I? Does the addition of personalized feedback improve rumination, treatment adherence, and treatment satisfaction compared to standard guided iCBT-I? Researchers will compare three conditions: (1) standard guided iCBT-I, (2) guided iCBT-I with additional rumination-tailored feedback, (3) waitlist control group, to determine whether the enhanced intervention leads to superior clinical and behavioral outcomes.
Participants will:
complete an online screening and baseline assessment be randomly assigned to one of three study conditions receive either guided iCBT-I, guided iCBT-I with rumination-tailored feedback, or no intervention (waitlist condition) complete a structured internet-based CBT-I program over several weeks (for intervention arms) receive weekly guidance according to group allocation complete post-treatment and follow-up questionnaires assessing sleep, rumination, and treatment experience
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* University students
* Aged 18 years or older
* Fluent in Persian and able to read and understand online study materials
* Reporting clinically relevant insomnia symptoms as indicated by screening measures
* Willing to complete online questionnaires and participate in an internet-based intervention program
Exclusion Criteria:
* Current severe psychiatric condition requiring immediate clinical attention (e.g., psychosis, mania, or active suicidal ideation)
* Current participation in another structured psychological treatment for insomnia (including CBT-I)
* Presence of a diagnosed sleep disorder other than insomnia that better explains sleep problems (e.g., sleep apnea, restless legs syndrome, narcolepsy)
* Regular night-shift work or highly irregular sleep-wake schedule that would interfere with CBT-I protocols
* Severe substance use problems that may interfere with participation or adherence
* Cognitive, language, or technological limitations that prevent completion of online assessments or intervention materials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.