Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents
A Randomised Controlled Trial of the Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening Chronotype
This study is testing if Cognitive Behavioural Therapy and bright light therapy can help teenagers and young adults who have trouble sleeping feel better and improve their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 12 Years to 24 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04256915 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Cognitive Behavioural Therapy for Insomnia (CBT-I) and bright light therapy in treating insomnia and mood symptoms in adolescents with an evening chronotype. Participants aged 12-24 who experience difficulty initiating sleep will be randomly assigned to receive either CBT-I, CBT-I combined with bright light therapy, or a waiting-list control. Assessments will occur at various stages throughout the treatment to evaluate changes in sleep patterns and overall functioning. The study aims to provide insights into the long-term effects of these interventions on sleep and mental health in youth.
Who should consider this trial
Good fit: Ideal candidates are Chinese adolescents aged 12-24 who experience significant difficulty initiating sleep at least three times a week and are classified as having an evening chronotype.
Not a fit: Patients with current substance abuse issues or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological treatment options for adolescents suffering from insomnia and related mood disorders.
How similar studies have performed: Previous studies have shown that CBT-I and light therapy are effective in adults, but this approach in adolescents is less explored, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Chinese aged 12-24 years old; 2. Predominant complaint of difficulty in initiating sleep at least three times a week and for at least 3 months; 3. Show clinically significant impairment / distress; 4. Having a score of \>= 9 on the Insomnia Severity Index (ISI) ; 5. Classified as evening chronotype based on the score of reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ; i.e. \<12) and having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, and 12:00am or later for 15 years or above at least 3 nights per week for the past 3 month as confirmed by a 7-day sleep diary; 6. Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18); 7. Being able to comply with the study protocol. Exclusion Criteria: 1. Current diagnosis of substance abuse or dependence; current or history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities; 2. Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema); 3. Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality (e.g. narcolepsy) as ascertained by the Structured Diagnostic Interview for Sleep Patterns and Disorder (DISP); 4. Concurrent, regular use of medications known to affect sleep continuity and quality; 5. Initiation of and change of medication that may interfere with circadian rhythm within past 3 months (e.g. lithium); 6. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt); 7. Currently receiving any other structured psychotherapy; 8. With hearing or speech deficit; 9. Presence of an eye disease (e.g. retinal blindness); 10. Night shift worker; 11. Trans-meridian flight in the past 3 months and during the study.
Where this trial is running
Hong Kong
- Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Shirley X Li, DClinPsy
- Email: shirley.li@hku.hk
- Phone: 39177035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.