Clinical Trial

Rumination-Tailored Guided Internet-Based CBT-I for University Students

Study acronym: RUM-CBTI
Active, Not Recruiting
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 changes
critical Trial status changed: Enrolling by Invitation → Active, Not Recruiting 2026-07-15
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-07-01
Trial Details
NCT Number NCT07623889
Lead Sponsor Shahid Beheshti University of Medical Sciences
Conditions Insomnia, Insomnia Disorder
Enrollment 70 participants
Start Date 2026-07-04
Primary Completion 2026-09 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-14