Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)

Last updated: March 16, 2026
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Insomnia

Treatment

app-based digital cognitive behavioral therapy for insomnia without AI chatbot

app-based digital cognitive behavioral therapy for insomnia with AI chatbot

Clinical Study ID

NCT06593262
14106223
  • Ages 18-25
  • All Genders

Study Summary

Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.

Eligibility Criteria

Inclusion

Inclusion Criteria:

i. Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older)

ii. Online informed consent of participation in the study should be provided

iii. Willing to comply with the requirements of the study protocol

iv. The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI)

v. difficulties initiating, maintaining or nonrestorative sleep over a 1-month period

vi. Having access to a smartphone and consistent internet access for their smartphone

vii. Accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention

Exclusion

Exclusion Criteria:

i. A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome

ii. A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder

iii. Presence of serious suicidality as evidenced by ideation with a plan or an attempt

iv. Receiving any pharmacological treatment (including sleep promoting agents)

v. Receiving any structured psychotherapy

vi. Having shiftwork and trans-meridian travel in the past 3 months and during the intervention

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: app-based digital cognitive behavioral therapy for insomnia without AI chatbot
Phase:
Study Start date:
July 26, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Department of Psychiatry, the Chinese University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

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