Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems

Официальное название

Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial

Обзор

This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.

Подробное описание

This is a two-arm, parallel pilot randomized controlled trial recruiting 100 university students in Hong Kong with mild to moderate symptoms of depression or anxiety who also screen positive for insomnia symptoms. All participants will receive brief sleep health advice and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. Participants in the intervention group will additionally receive 12 weeks of chatbot-delivered insomnia management intervention, including 2 weeks of daily sleep diary monitoring and 10 weeks of nurse-led instant messaging support grounded in cognitive behavioral therapy for insomnia (CBT-I). The primary outcome is self-reported insomnia severity at 6-month follow-up. Secondary outcomes include health-related quality of life, sleep related quality of life, sleep effort, pre-sleep arousal, anxiety and depression assessed at 3 and 6 months. Analyses will be conducted on intention-to-treat basis.

Вмешательства

• Поведенческое Brief sleep health advice
  At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia.
• Поведенческое 2 weeks of chatbot-based daily sleep diary
  Following randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tai
• Поведенческое 10 weeks chatbot-based IM support
  Participants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24/7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-deliver

Первичные конечные точки

• Self-reported insomnia severity [Срок оценки: 6-month follow-up]

Вторичные конечные точки (6)

• Health-related quality of life [Срок оценки: 3- and 6-month follow-ups]
• Sleep-related quality of life [Срок оценки: 3- and 6-month follow-ups]
• Depressive symptoms [Срок оценки: 3- and 6-month follow-ups]
• Anxiety symptoms [Срок оценки: 3- and 6-month follow-ups]
• Sleep effort [Срок оценки: 3- and 6-month follow-ups]
• Pre-sleep arousal [Срок оценки: 3- and 6-month follow-ups]

Критерии участия

Критерии включения

• Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.
• Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and/or a PHQ-9 score of 5-14 at baseline.
• Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.
• Reporting a self-reported sleep efficiency of less than 85% over the past month.
• Able to communicate in Chinese.

Критерии исключения

• Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder
• Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months
• Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional
• Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Гонконг · 1 центр

• School of Public Health, The University of Hong Kong, 18/F, Metro South Tower 1, 39 Wong C — Гонконг

Идентификаторы

NCT: NCT07711769 · dCBT-I in University Students

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗