NCT07399964 Effects of CBT-I on Impulsivity and Risk Taking in Youths With Insomnia
| NCT ID | NCT07399964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2026-12-01 |
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 124 participants in total. It began in 2024-06-19 with a primary completion date of 2026-12-01.
⚠ 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 is prevalent in adolescents. Impulsive behaviours and excessive risk-taking have been linked to the manifestation of psychopathology in youths. Previous research based on behavioural and neurophysiological measures has found that individuals with insomnia demonstrated impaired inhibitory control, which is associated with detrimental outcomes such as substance abuse and self-harm. Existing evidence has shown some positive effects of cognitive behavioural therapy for insomnia (CBT-I) on insomnia symptoms and daytime functioning in youths. Given the link between insomnia and impulsivity reported in previous research, and sleep as a highly modifiable factor, we are conducting this randomised controlled trial to examine the impact of CBT-I in improving impulsivity and risk-taking in youth with insomnia.
Eligibility Criteria
Inclusion Criteria: * Chinese aged 12-24 years old * Written informed consent of participation in the study is given by the participant and his/her parent or guardian (for those aged under 18) * Willing to comply with the study protocol * Meeting the DSM-V diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) \>= 9 (suggested cut-off for adolescents) Exclusion Criteria: * A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities * Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease) * Having a clinically diagnosed sleep disorder (other than insomnia disorder) that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria * Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter OTC medications (e.g. melatonin, Traditional Chinese Medicine, TCM) * In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) * Currently receiving any psychological treatment for insomnia * With hearing or speech deficit * Night shift worker
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07399964 clinical trial?
This trial is open to participants of all sexes, aged 12 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 NCT07399964 currently recruiting?
Yes, NCT07399964 is actively recruiting participants. Contact the research team at shirleyx@hku.hk for enrollment information.
Where is the NCT07399964 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07399964 clinical trial?
NCT07399964 is sponsored by The University of Hong Kong. The trial plans to enroll 124 participants.
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