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

NCT04256915 | Recruiting

• 1 other identifier: EA1802063
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Delayed Sleep Phase

Keywords

Insomnia; Eveningness; Adolescents; Youth; Light therapy

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Symptoms

  Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.

  Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

Secondary Outcomes (36)

• Change in Sleep Quality

  Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

• Change of Sleep Diary Measure - Time in Bed (TIB)

  Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

• Change of Sleep Diary Measure - Total Sleep Time (TST)

  Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

• Change of Sleep Diary Measure - Sleep Onset Latency (SOL)

  Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

• Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)

  Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

Study Arms (3)

CBT-I + Bright Light

EXPERIMENTAL

n = 50

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

CBT-I + Placebo Light

ACTIVE COMPARATOR

n = 50

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

Wait-list Control

NO INTERVENTION

n = 50

Interventions

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

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

CBT-I + Placebo Light

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Chinese aged 12-24 years old;
• Predominant complaint of difficulty in initiating sleep at least three times a week and for at least 3 months;
• Show clinically significant impairment / distress;
• Having a score of \>= 9 on the Insomnia Severity Index (ISI) ;
• 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;
• Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
• Being able to comply with the study protocol.

You may not qualify if:

• 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;
• Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema);
• 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);
• Concurrent, regular use of medications known to affect sleep continuity and quality;
• Initiation of and change of medication that may interfere with circadian rhythm within past 3 months (e.g. lithium);
• 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 other structured psychotherapy;
• With hearing or speech deficit;
• Presence of an eye disease (e.g. retinal blindness);
• Night shift worker;
• Trans-meridian flight in the past 3 months and during the study.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• University of Oxford: collaborator
• Flinders University: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 38594725 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Phototherapy; Therapeutics

Central Study Contacts

Shirley X Li, DClinPsy

CONTACT

39177035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: For both treatment groups, the intervention will consist of 6 weekly sessions of cognitive behavioural therapy for insomnia (CBT-I) (90-min, 3-6 adolescents in each group). Participants in both groups will be also instructed to undergo morning light therapy (by wearing Re-timers) at home for 30 minutes daily. Re-timers can be worn like a pair of glasses, with 2 light-emitting diodes (LEDs) per eye. The following two conditions will be delivered by Re-timers: participants in the CBT-I group will receive a placebo light intervention where they will be exposed to dim red light (50lux), whereas participants in the CBT-I plus light therapy group will receive the active light treatment, with 2 LEDs emitting constant diffused blue-green light (500 nm, 506 lux).

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

HK (1)