Authors
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Shahid Beheshti University of Medical Sciences -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
This study is a pilot randomized controlled trial with three parallel arms. Participantswill be randomly assigned to either (1) guided internet‐based cognitive behavioraltherapy 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 toevaluate the feasibility and preliminary efficacy of integrating targeted cognitivefeedback 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, reportingclinically relevant insomnia symptoms, and willing to complete online questionnaires anduse the internet‐based intervention platform.Participants will be excluded if they have a current severe psychiatric conditionrequiring immediate treatment, such as psychosis, mania, or active suicidal intent; arecurrently receiving another structured insomnia treatment or CBT‐I program; have adiagnosed 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 orhave 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 acognitive or language problem that prevents completion of the online materials orquestionnaires.The base intervention consists of a structured guided internet‐based CBT‐I programincluding standard components such as sleep restriction, stimulus control, cognitiverestructuring, sleep hygiene education, and relaxation techniques. Participants receiveweekly brief supportive guidance during the intervention period (for intervention armsonly).In the experimental condition, participants additionally receive rumination‐tailored,rule‐based personalized feedback generated based on their levels of repetitive negativethinking and sleep‐related cognitive arousal. The feedback is predefined according todecision rules and is not dynamically generated. The feedback targets repetitive negativethinking patterns, sleep‐related worry and cognitive arousal, and maladaptive pre‐sleepcognition. Feedback is delivered in written format alongside standard CBT‐I guidance andis designed to complement, not replace, core therapeutic components.Participants in the waitlist control condition will not receive immediate interventionduring the study period. After study completion, they will be offered access to theguided iCBT‐I program.The primary outcome is insomnia severity measured using a validated insomniaquestionnaire. 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 parallelgroup randomized design with balanced allocation. Due to the nature of the intervention,participants and intervention providers cannot be blinded. Outcome assessment is based onself‐report measures, and participants will be aware of their group allocation.Assessments will be conducted at baseline, post‐intervention, and follow‐up. Datacollection will be fully online through a secure platform. Participants will completeweekly monitoring measures during the intervention period.Feasibility will be evaluated through recruitment rate, retention, and adherence tointervention modules. Acceptability will be assessed using self‐reported treatmentsatisfaction.Insomnia is frequently maintained by cognitive arousal and repetitive negative thinking,particularly rumination before sleep. While standard CBT‐I is effective, variability intreatment response suggests a need for personalization. This study investigates whetheraugmenting CBT‐I with structured rumination‐focused feedback can improve engagement andoutcomes in a scalable digital format.
Epistemonikos ID: d5c8d08e4ed4732925f8f5ba9f8b0d3b3074fb40
First added on: Jun 04, 2026