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

NCT ID: NCT06593262

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents

Interventions

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

digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents

Intervention Type BEHAVIORAL

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

digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Tim M. H. Li

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry, the Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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14106223

Identifier Type: -

Identifier Source: org_study_id

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