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临床试验/NCT07623889
NCT07623889进行中(未招募)不适用

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

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年7月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
1

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Guided CBT-I

Active Comparator

干预措施: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) (Behavioral)

CBT-I + Rumination Feedback

Experimental

干预措施: Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) (Behavioral)

CBT-I + Rumination Feedback

Experimental

干预措施: Rumination-Tailored Rule-Based Personalized Feedback (Behavioral)

Waitlist Control

No Intervention

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rasool Hamidi Choolabi

Researcher in Clinical Psychology

Shahid Beheshti University of Medical Sciences

研究点 (1)

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