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Search / Trial NCT06156306

CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety

Launched by CHINESE UNIVERSITY OF HONG KONG · Nov 27, 2023

Trial Information

Current as of November 05, 2025

Recruiting

Keywords

Insomnia Anxiety Youth

ClinConnect Summary

This clinical trial is studying two different types of therapy to help young people aged 15 to 24 who have trouble sleeping (insomnia) and feelings of anxiety. Specifically, it compares a method called Cognitive Behavioral Therapy for Insomnia (CBT-I) with a combination of CBT-I and Acceptance and Commitment Therapy (ACT). The goal is to see which approach works better at reducing anxiety symptoms and improving sleep.

To participate, young people must be between 15 and 24 years old, have significant sleep problems and anxiety, and be able to communicate in Chinese and Cantonese. It's important that they also have a smartphone to take part in the study. However, those with certain serious mental health conditions or other specific sleep disorders won't be eligible. Participants can expect to receive either of the therapies and will help researchers understand how these treatments can benefit young people experiencing insomnia and anxiety.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Youth who meet the following criteria would be eligible for taking part in this trial:
  • i. Chinese youth aged 15-24 years old, ii. Presence of insomnia problems as defined by insomnia severity index (ISI) using cut-off of 9, which has been locally validated cut off for detecting clinical insomnia), iii. Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 10 for detecting clinical anxiety, iv. Ability to listen, speak, and read Chinese and Cantonese, and v. Written informed consent of participation into the study is given by youth and his/her parent's if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi. Possession of smartphone
  • Exclusion Criteria:
  • A youth would be excluded from the study if meeting one or more of the following criteria:
  • i. A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability ii. Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP) iii. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID) iv. Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.

About Chinese University Of Hong Kong

The Chinese University of Hong Kong (CUHK) is a prestigious research institution renowned for its commitment to advancing medical science and improving healthcare outcomes. As a clinical trial sponsor, CUHK leverages its extensive academic resources and interdisciplinary expertise to conduct innovative research that addresses critical health challenges. The university fosters collaboration among leading researchers, healthcare professionals, and industry partners, ensuring rigorous study design and implementation. CUHK is dedicated to upholding the highest ethical standards in clinical research, with a focus on translating findings into tangible benefits for patients and the broader community.

Locations

Sha Tin, New Territories, Hong Kong

Patients applied

1 patients applied

Trial Officials

Rachel Ngan Yin Chan, PhD

Principal Investigator

Department of Psychiatry, the Chinese University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported