NCT06156306 CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety
| NCT ID | NCT06156306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-12-15 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and/or mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.
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.
Contact & Investigator
Rachel Ngan Yin Chan, PhD
PRINCIPAL INVESTIGATOR
Department of Psychiatry, the Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06156306 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 24 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06156306 currently recruiting?
Yes, NCT06156306 is actively recruiting participants. Contact the research team at rachel.chan@cuhk.edu.hk for enrollment information.
Where is the NCT06156306 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06156306 clinical trial?
NCT06156306 is sponsored by Chinese University of Hong Kong. The principal investigator is Rachel Ngan Yin Chan, PhD at Department of Psychiatry, the Chinese University of Hong Kong. The trial plans to enroll 50 participants.
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