Trials / Recruiting
RecruitingNCT04256915
Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening Chronotype
A Randomised Controlled Trial of the Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening Chronotype
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- The University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 12 Years – 24 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A randomised, assessor-blind, parallel group controlled trial will be conducted in youth with insomnia and eveningness. Eligible participants will be randomised to one of the following groups: CBT-I, CBT-I plus bright light therapy, or waiting-list control. Randomisation will be carried out using an automated online system. Assessments will be conducted at pre-treatment (week 0), during the treatment (week 2 \& 4) and post-treatment (week 6/at the conclusion of the last group session). The two active treatment groups will be additionally followed up at post-treatment one-month and post-treatment six months in order to examine the maintenance effects following the intervention with CBT-I and CBT-I plus bright light therapy respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2020-02-05
- Last updated
- 2024-05-09
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT04256915. Inclusion in this directory is not an endorsement.