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

May 28, 2026 updated by: Rasool Hamidi Choolabi, Shahid Beheshti University of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI) Score
Time Frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ruminative Responses Scale (RRS-22) Total Score
Time Frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
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
Time Frame: Time Frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
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
Time Frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
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
Time Frame: Post-intervention (Week 6)
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
Time Frame: Throughout the 6-week intervention period
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
Time Frame: Throughout the 6-week intervention period
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
Time Frame: From baseline (Week 0) to post-intervention assessment (Week 6)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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