Status:
ENROLLING_BY_INVITATION
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Insomnia
Eligibility:
All Genders
18-25 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06593262
Start Date
July 26 2024
End Date
June 1 2025
Last Update
February 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Psychiatry, the Chinese University of Hong Kong
Hong Kong, Hong Kong