CBT for insomnia to reduce impulsivity and risky behavior in young people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, assessor-blind, parallel-group trial comparing group-based CBT-I with a health-related psychoeducation control in youths with DSM-5 insomnia disorder. Participants meeting inclusion criteria will be randomly assigned using an automated online system and will complete assessments at baseline, one week after the 7-week intervention, and at 6 months to measure maintenance effects. Outcomes include self-report and objective measures of impulsivity and risk-taking alongside insomnia severity and daytime functioning. The trial is conducted at the Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong.

Why it matters

Who can join: the full rules

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

Where it's running

• Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Shirley Xin LI, DClinPsy, PhD
• Email: shirleyx@hku.hk
• Phone: 39177035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.