InsomniaRUM-CBTINCT07623889
Rumination-Tailored Guided Internet-Based CBT-I for University Students
A study testing Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) and Rumination-Tailored Rule-Based Personalized Feedback in people with Insomnia and Insomnia Disorder, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Insomnia Disorder
- What is being tested?
- Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) and Rumination-Tailored Rule-Based Personalized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 4 Jul 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Insomnia, Insomnia Disorder
- Being tested
- Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I), Rumination-Tailored Rule-Based Personalized Feedback
- Keywords
- Internet-based CBT-I, guided CBT-I, cognitive behavioral therapy for insomnia, rumination, personalized feedback, university students, sleep intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I)Behavioural
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.
Rumination-Tailored Rule-Based Personalized FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided CBT-I | Active comparator | Not described Receives: Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) |
| CBT-I + Rumination Feedback | Experimental | Not described Receives: Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I); Behavioral: Rumination-Tailored Rule-Based Personalized Feedback |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (Week 6)
Intervention Module Completion Rate
Treatment adherence will be assessed by the percentage of completed intervention modules during the study period.
Measured: 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.
Measured: 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.
Measured: From baseline (Week 0) to post-intervention assessment (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start4 Jul 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasool Hamidi Choolabi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623889
- Sponsor's protocol ID
- ICBTI-RUM-2026
- Acronym
- RUM-CBTI
- Status last verified
- Jul 2026
- First submitted
- 23 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of Rumination-tailored Feedback in Guided Internet-based CBT-I for University Students
- ClinicalTrials.gov ID
- NCT07623889
- Acronym / sponsor ID
- RUM-CBTI / ICBTI-RUM-2026
- Conditions
- Insomnia, Insomnia Disorder
- Keywords
- Internet-based CBT-I, guided CBT-I, cognitive behavioral therapy for insomnia, rumination, personalized feedback, university students, sleep intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 4 Jul 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided CBT-I | Active comparator | Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) |
| CBT-I + Rumination Feedback | Experimental | Behavioral: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I), Behavioral: Rumination-Tailored Rule-Based Personalized Feedback |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBT-I + Rumination Feedback, Guided CBT-I |
| Rumination-Tailored Rule-Based Personalized FeedbackParticipants 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. | Behavioural | CBT-I + Rumination Feedback |
Primary outcome
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.
7 secondary outcomes
Ruminative Responses Scale (RRS-22) Total Score
Time frame: 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)
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: 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)
Intervention Module Completion Rate
Time frame: Throughout the 6-week intervention period
Sleep Diary Completion Rate
Time frame: Throughout the 6-week intervention period
Study Dropout Rate
Time frame: From baseline (Week 0) to post-intervention assessment (Week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) and Rumination-Tailored Rule-Based Personalized Feedback in people with Insomnia and Insomnia Disorder, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) Score (time frame: Baseline (Week 0), post-intervention (Week 6), and follow-up (Week 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.