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RECRUITING

NCT04256915

Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening Chronotype

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

Insomnia is prevalent in adolescents. Together with an increase of evening preference (i.e. evening chronotype) in adolescent, sleep disturbance in adolescents are associated with a constellation of adverse outcomes. Insomnia and evening chronotype in adolescents are also found to predict the development of mental health problems and negative health-related outcomes in young adulthood. While cognitive behavioural therapy for insomnia (CBT-I) and bright light therapy were evidenced to be effective in managing sleep problems in adults, there is limited evidence to support their efficacy in children and adolescents. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial to examine the effects of CBT-I and light therapy on insomnia and mood symptoms, and other clinical and daytime symptoms, as well as overall functioning in adolescents with insomnia (particularly sleep onset insomnia) and evening chronotype.

Official title: A Randomised Controlled Trial of the Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening Chronotype

Key Details

Gender

All

Age Range

12 Years - 24 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-03-01

Completion Date

2025-12-31

Last Updated

2024-05-09

Healthy Volunteers

Conditions

Insomnia Delayed Sleep Phase

Interventions

BEHAVIORAL

Cognitive Behavioural Therapy for Insomnia (CBT-I) + Bright Light Therapy

CBT-I consists of 6 weekly sessions of CBT-I (90-min, 3-6 adolescents in each group) with elements that address the behavioural, cognitive and physiological factors perpetuating insomnia, including: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. Participants will additionally undergo daily morning light therapy by wearing Re-timers (a validated portable light emitting device) at home for 30 minutes. Participants will receive constant blue-green light (500 nm, 506 lux).

BEHAVIORAL

Cognitive Behavioural Therapy for Insomnia (CBT-I) + Placebo Light Therapy

CBT-I consists of 6 weekly sessions of CBT-I (90-min, 3-6 adolescents in each group) with elements that address the behavioural, cognitive and physiological factors perpetuating insomnia, including: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. Participants will additionally undergo daily morning light therapy by wearing Re-timers (a validated portable light emitting device) at home for 30 minutes.Participants will receive red-filtered dim light (\<50 lux).

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.

Locations (1)

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

Hong Kong, Hong Kong