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

Overview

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

This study is a pilot randomized controlled trial with three parallel arms. Participants will be randomly assigned to either (1) guided internet-based cognitive behavioral therapy for insomnia (iCBT-I), (2) guided iCBT-I with additional rumination-tailored, rule-based personalized feedback, or (3) a waitlist control group. The study aims to evaluate the feasibility and preliminary efficacy of integrating targeted cognitive feedback into a digital insomnia intervention. The study will recruit university students with clinically relevant insomnia symptoms. Participants will be included if they are university students, 18 years of age or older, fluent in Persian and able to read and understand online study materials, reporting clinically relevant insomnia symptoms, and willing to complete online questionnaires and use the internet-based intervention platform. Participants will be excluded if they have a current severe psychiatric condition requiring immediate treatment, such as psychosis, mania, or active suicidal intent; are currently receiving another structured insomnia treatment or CBT-I program; have a diagnosed sleep disorder other than insomnia that would better explain the sleep problem, such as sleep apnea, restless legs syndrome, or narcolepsy; work regular night shifts or have a highly irregular sleep-wake schedule that would make the intervention unsuitable; have a substance use problem severe enough to interfere with participation; or have a cognitive or language problem that prevents completion of the online materials or questionnaires. The base intervention consists of a structured guided internet-based CBT-I program including standard components such as sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relaxation techniques. Participants receive weekly brief supportive guidance during the intervention period (for intervention arms only). In the experimental condition, participants additionally receive rumination-tailored, rule-based personalized feedback generated based on their levels of repetitive negative thinking and sleep-related cognitive arousal. The feedback is predefined according to decision rules and is not dynamically generated. The feedback targets repetitive negative thinking patterns, sleep-related worry and cognitive arousal, and maladaptive pre-sleep cognition. Feedback is delivered in written format alongside standard CBT-I guidance and is designed to complement, not replace, core therapeutic components. Participants in the waitlist control condition will not receive immediate intervention during the study period. After study completion, they will be offered access to the guided iCBT-I program. The primary outcome is insomnia severity measured using a validated insomnia questionnaire. Secondary outcomes include repetitive negative thinking (rumination), treatment adherence, treatment satisfaction, and dropout rate. Participants will be randomly allocated to one of three study conditions using a parallel group randomized design with balanced allocation. Due to the nature of the intervention, participants and intervention providers cannot be blinded. Outcome assessment is based on self-report measures, and participants will be aware of their group allocation. Assessments will be conducted at baseline, post-intervention, and follow-up. Data collection will be fully online through a secure platform. Participants will complete weekly monitoring measures during the intervention period. Feasibility will be evaluated through recruitment rate, retention, and adherence to intervention modules. Acceptability will be assessed using self-reported treatment satisfaction. Insomnia is frequently maintained by cognitive arousal and repetitive negative thinking, particularly rumination before sleep. While standard CBT-I is effective, variability in treatment response suggests a need for personalization. This study investigates whether augmenting CBT-I with structured rumination-focused feedback can improve engagement and outcomes in a scalable digital format.