Rumination-Tailored Guided Internet-Based CBT-I for University Students

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

Conditions

• Insomnia
• Insomnia Disorder

Interventions

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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-04

Primary Completion

2026-09-30

Completion

2026-10-31

Countries

• Iran

Study Locations