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

NCT ID: NCT04256915

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

Brief 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

Insomnia; Delayed Sleep Phase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I + Bright Light

n = 50

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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).

CBT-I + Placebo Light

n = 50

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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).

Wait-list Control

n = 50

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Flinders University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirley Xin Li

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shirley X Li, DClinPsy

Role: CONTACT

shirley.li@hku.hk

39177035

Facility Contacts

Shirley X Li, DClinPsy

Role: primary

shirley.li@hku.hk

39177035

References

Li SX, Cheung FTW, Chan NY, Chan JWY, Zhang J, Li AM, Espie CA, Gradisar M, Wing YK. Effects of cognitive behavioural therapy and bright light therapy for insomnia in youths with eveningness: study protocol for a randomised controlled trial. Trials. 2024 Apr 9;25(1):246. doi: 10.1186/s13063-024-08090-0.

Reference Type: DERIVED

PMID: 38594725 (View on PubMed)

Other Identifiers

EA1802063

Identifier Type: -

Identifier Source: org_study_id