Rumination-Tailored Guided Internet-Based CBT-I for University Students (RUM-CBTI)

A Pilot Randomized Trial of Rumination-tailored Feedback in Guided Internet-based CBT-I for University Students

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Insomnia Disorder
• Intervention / Treatment: Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I); Behavioral: Rumination-Tailored Rule-Based Personalized Feedback

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasool Hamidi Choolabi; Phone Number: +989213014631; Email: rasoolhamidi.official@gmail.com
• Study Contact Backup: Name: Omid Amani; Email: o.amani69@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control
Active Comparator: Guided CBT-I	Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I); Participants receive a structured guided internet-based cognitive behavioral therapy program for insomnia (iCBT-I). The intervention includes core CBT-I components such as sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, relaxation techniques, and sleep-related behavioral recommendations. The program is delivered online over several weeks. Participants receive brief weekly supportive guidance throughout the intervention period.
Experimental: CBT-I + Rumination Feedback	Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I); Participants receive a structured guided internet-based cognitive behavioral therapy program for insomnia (iCBT-I). The intervention includes core CBT-I components such as sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, relaxation techniques, and sleep-related behavioral recommendations. The program is delivered online over several weeks. Participants receive brief weekly supportive guidance throughout the intervention period.; Behavioral: Rumination-Tailored Rule-Based Personalized Feedback; Participants receive predefined personalized feedback targeting repetitive negative thinking and rumination-related cognitive processes associated with insomnia. Feedback is generated according to rule-based decision algorithms derived from participants' rumination severity, brooding and reflection patterns, treatment adherence, and longitudinal change during the intervention period. Feedback messages focus on cognitive distancing, reduction of maladaptive repetitive thinking, attentional regulation, behavioral activation, and structured problem solving. Personalized feedback is delivered in written format alongside the standard guided iCBT-I program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI) Score	Insomnia severity will be assessed using the Persian version of the Insomnia Severity Index (ISI). Higher scores indicate greater insomnia severity.	Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ruminative Responses Scale (RRS-22) Total Score	Rumination severity will be assessed using the Persian version of the 22-item Ruminative Responses Scale (RRS-22). Higher scores indicate greater repetitive negative thinking and rumination.	Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) Score	Sleep-related dysfunctional beliefs and attitudes will be assessed using the Persian version of the Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS). Higher scores indicate greater maladaptive sleep-related cognitions.	Time Frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Pittsburgh Sleep Quality Index (PSQI) Score	Sleep quality will be assessed using the Persian version of the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer subjective sleep quality.	Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Client Satisfaction Questionnaire (CSQ-8) Total Score	Treatment satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-8). Higher scores indicate greater satisfaction with the intervention.	Post-intervention (Week 6)
Intervention Module Completion Rate	Treatment adherence will be assessed by the percentage of completed intervention modules during the study period.	Throughout the 6-week intervention period
Sleep Diary Completion Rate	Adherence to daily sleep monitoring will be assessed by the percentage of completed sleep diary entries.	Throughout the 6-week intervention period
Study Dropout Rate	Dropout rate will be defined as discontinuation of participation before completion of the post-intervention assessment.	From baseline (Week 0) to post-intervention assessment (Week 6)

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: university students; rumination; cognitive behavioral therapy for insomnia; personalized feedback; sleep intervention; Internet-based CBT-I; guided CBT-I
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Digestive System Diseases; Gastrointestinal Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Feeding and Eating Disorders; Rumination Syndrome; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: ICBTI-RUM-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) collected in this study will include demographic information, baseline characteristics, questionnaire responses (e.g., insomnia severity, rumination, sleep quality), treatment adherence indicators, and treatment outcome measures. No directly identifiable personal information will be shared. All data will be fully anonymized prior to sharing.
• IPD Sharing Time Frame: De-identified IPD and supporting documents will become available after publication of the primary study results or within 12 months after study completion, whichever occurs first. Data will remain available for a minimum of 5 years following publication.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents will be granted upon reasonable request to qualified researchers for academic and non-commercial purposes. Requests will be reviewed by the principal investigator. Data will be shared under a data use agreement to ensure confidentiality, ethical use, and compliance with institutional and ethical guidelines. Only de-identified datasets will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No