Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)
NCT ID: NCT06593262
Last Updated: 2025-02-06
Study Results
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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ENROLLING_BY_INVITATION
NA
168 participants
INTERVENTIONAL
2024-07-26
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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app-based digital cognitive behavioral therapy for insomnia with AI chatbot
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
app-based digital cognitive behavioral therapy for insomnia without AI chatbot
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
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
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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
25 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Tim M. H. Li
Prof.
Locations
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Department of Psychiatry, the Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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14106223
Identifier Type: -
Identifier Source: org_study_id
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