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NCT07623889
Rumination-Tailored Guided Internet-Based CBT-I for University Students
Conditions: Insomnia, Insomnia Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 70
Sponsor: Shahid Beheshti University of Medical Sciences
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07623889). StuddyBuddy aggregates publicly available trial information.
