Clinical trial NCT04256915: Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Delayed Sleep Phase
Keywords: Insomnia
Eveningness
Adolescents
Youth
Light therapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: University of Oxford
name: Flinders University
First posted: 2020-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Insomnia Symptoms
timeFrame: 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:
measure: Change in Sleep Quality
timeFrame: 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
measure: Change of Sleep Diary Measure - Time in Bed (TIB)
timeFrame: 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
measure: Change of Sleep Diary Measure - Total Sleep Time (TST)
timeFrame: 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
measure: Change of Sleep Diary Measure - Sleep Onset Latency (SOL)
timeFrame: 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
measure: Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)
timeFrame: 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
measure: Change of Sleep Diary Measure - Sleep Efficiency (SE)
timeFrame: 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
measure: Change in Objective Sleep Measures - Time in Bed (TIB)
timeFrame: 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
measure: Change in Objective Sleep Measures - Total Sleep Time (TST)
timeFrame: 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
measure: Change in Objective Sleep Measures - Sleep Onset Latency (SOL)
timeFrame: 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
measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
timeFrame: 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
measure: Change in Objective Sleep Measures - Sleep Efficiency (SE)
timeFrame: 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
measure: Change in Self-Report Chronotype Measures
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - interdaily stability (IS)
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - intradaily variability (IV)
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - M10
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - L5
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - relative amplitude (RA)
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Cosinor Analysis - acrophase
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Cosinor Analysis - amplitude
timeFrame: 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
measure: Change in Actigraphic Circadian Measures using Cosinor Analysis - mesor
timeFrame: 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
measure: Change in Objective Circadian Measures: Dim-light melatonin onset (DLMO)
timeFrame: Baseline, Post-Treatment (at the conclusion of the last session) for all participants
measure: Change of Depressive Symptoms (Assessor-rated)
timeFrame: 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
measure: Change of Self-report Mood Symptoms
timeFrame: 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
measure: Change of Suicidal Ideation
timeFrame: 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
measure: Change of Daytime Sleepiness
timeFrame: 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
measure: Change of Daytime Fatigue
timeFrame: 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
measure: Change of Quality of Life (KIDSCREEN-27)
timeFrame: 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
measure: Change of Overall Severity of Clinical Symptoms
timeFrame: 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
measure: Change of Objective Cognitive Performance (visual attention & task switching)
timeFrame: 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
measure: Change of Objective Cognitive Performance (inhibitory ability)
timeFrame: 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
measure: Change of Objective Cognitive Performance (working memory by digit span)
timeFrame: 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
measure: Change of Objective Cognitive Performance (working memory by N-Back)
timeFrame: 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
measure: Change of Objective Cognitive Performance (episodic memory)
timeFrame: 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
measure: Change of Objective Cognitive Performance (problem solving)
timeFrame: 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
measure: Change of sleep related attention bias
timeFrame: 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
measure: Change of risk-taking & decision making
timeFrame: 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
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
References: