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
1 other identifier
interventional
70
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
June 3, 2026
May 1, 2026
3 months
May 23, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Ruminative Responses Scale (RRS-22) Total Score
Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) Score
Time Frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Pittsburgh Sleep Quality Index (PSQI) Score
Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Client Satisfaction Questionnaire (CSQ-8) Total Score
Post-intervention (Week 6)
Intervention Module Completion Rate
Throughout the 6-week intervention period
- +2 more secondary outcomes
Study Arms (3)
Guided CBT-I
ACTIVE COMPARATORCBT-I + Rumination Feedback
EXPERIMENTALWaitlist Control
NO INTERVENTIONInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher in Clinical Psychology
Study Record Dates
First Submitted
May 23, 2026
First Posted
June 3, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
June 3, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- 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.
- 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.
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.