Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD, Insomnia, and Evening Chronotype
20. August 2026 aktualisiert von: Dr. Shirley Xin Li, The University of Hong Kong
Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD and Comorbid Insomnia and Evening Chronotype: A Randomised, Assessor Blind, Parallel-group Trial
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by persistent inattention, hyperactivity, and impulsivity.
In adolescents and young people, ADHD is commonly accompanied by insomnia and circadian delay.
These co-occurring sleep and circadian disturbances may negatively affect daytime functioning and overall clinical outcomes.
Although cognitive behavioural therapy for insomnia (CBT-I) is considered the first-line treatment for insomnia, and bright light therapy may help address circadian issues, their efficacy in adolescents with ADHD and comorbid insomnia and eveningness remains unexplored.
This study aims to evaluate whether CBT-I, with or without bright light therapy, improves insomnia, sleep, and circadian as well as other clinical outcomes, and cognitive functioning in youths with ADHD and whether these interventions can also lead to improvements in mood and other clinical symptoms, as well as cognitive functioning.
Studienübersicht
Status
Noch keine Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
An assessor-blind, three-arm, parallel-group, randomised controlled trial will be conducted in youths with ADHD, comorbid insomnia, and evening chronotype. Eligible participants will be randomised to one of three conditions: CBT-I plus bright light therapy, CBT-I plus placebo light therapy, or a waiting-list control group.
The active intervention will consist of six weekly group-based CBT-I sessions, with daily morning light treatment beginning from the second week of intervention. Participants in the bright light therapy group will receive active blue-green light treatment delivered by light therapy glasses, whereas those in the CBT-I only group will receive placebo light therapy delivered via the same device. Assessments will be conducted at baseline and post-treatment for all the study participants, and additionally 1-month follow-up and 6-month follow-up for those in the two active intervention groups to evaluate the immediate and maintenance effects of the treatment. Outcome measures will include self-reported, clinician-rated, and objective assessments of sleep, circadian rhythm, arousal, ADHD symptoms, mood symptoms, cognitive functioning, and other daytime functioning outcomes.
Studientyp
Interventionell
Einschreibung (Geschätzt)
150
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Shirley X Li, DClinPsy
- Telefonnummer: 39177035
- E-Mail: shirley.li@hku.hk
Studienorte
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Hong Kong, Hongkong
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong, Hong Kong,
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Kontakt:
- Shirley Xin Li Dr., DClinPsy
- Telefonnummer: +852 3917-7035
- E-Mail: shirley.li@hku.hk
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion criteria:
An adolescent who meets the following criteria will be eligible for taking part in this study:
- aged 10-24 years old;
- ADHD diagnosis confirmed by DISC-IV;
- DSM-5 diagnosis of insomnia disorder with an ≥ 9 (suggested cut-off for adolescents);
- Being classified as evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, 12:00am or later for 15-17 years old [64], 10:56pm or later for 18-24 years old at least 3 nights per week in the past 3 months and as confirmed by a 7-day sleep diary;
- Written informed consent from the participant and their parent/guardian (for those aged under 18);
- Being able to comply with the study protocol;
- Either not on ADHD medication or stabilized on medications for at least 6 months.
Exclusion criteria:
An adolescent who meets one or more of the following criteria will be excluded from the study:
- Substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia, ASD, organic mental disorders, or intellectual disabilities;
- Prominent medical condition affecting sleep (e.g., severe eczema, GERD);
- Clinically diagnosed sleep disorder other than insomnia disorder, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both prescribed medications (e.g., hypnotics, steroids) and over-the-counter OTC medications (e.g., melatonin, Traditional Chinese Medicine, TCM), except for ADHD stimulants;
- Ongoing psychological treatment for sleep problems;
- With hearing or speech deficit;
- Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: CBT-I with Bright Light Therapy
The intervention for the CBT-I plus bright light therapy group will involve six weekly 90-minute group-based, face-to-face sessions of CBT-I, together with daily home-based morning bright light therapy starting from week 2. The CBT-I components are designed to address the behavioural, cognitive, and physiological factors that perpetuate insomnia while taking into account the sleep and circadian features of adolescents with ADHD, and include psychoeducation about sleep, circadian rhythm, and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring, and relapse prevention.
Bright light therapy will be administered at home using a portable light device for 30 minutes each morning, with timing individually determined and adjusted according to weekly sleep diary data.
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Refer to the arm description
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Experimental: CBT-I with Placebo Light Therapy
The intervention for the CBT-I plus placebo light therapy group will involve six weekly 90-minute group-based, face-to-face sessions of CBT-I delivered, together with daily home-based morning placebo light therapy starting from week 2. The CBT-I components are designed to address the behavioural, cognitive, and physiological factors that perpetuate insomnia while taking into account the sleep and circadian features of adolescents with ADHD and include psychoeducation about sleep, circadian rhythm, and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring, and relapse prevention.
Placebo light therapy will be administered at home using a portable placebo light device for 30 minutes each morning, with timing individually determined and adjusted according to weekly sleep diary data.
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Refer to the arm description
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Kein Eingriff: Waitlist control
Participants in the waiting-list control group will not receive any active intervention during the study period but will complete the same set of assessments as the intervention groups at baseline and at post-waiting.
This group will serve as a comparator for evaluating changes in outcomes over time.
Participants will continue with their usual care and clinical follow-up as appropriate during the waiting period.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in insomnia severity
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Insomnia symptoms measured by Insomnia Severity Index (ISI).
Insomnia Severity Index is a 5-item self-rated scale.
Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in pre-sleep arousal
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Pre-Sleep Arousal Scale (PSAS) is a 16-item self-rated scale measuring pre-sleep arousal.
There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40).
In both cases, a higher score indicates higher pre-sleep arousal.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in sleep-related dysfunctional beliefs and attitudes
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues.
A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of sleep hygiene and practice
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of sleep diary measure (total sleep time, TST)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Daily sleep diary for consecutive seven days.
Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of sleep diary measure (sleep onset latency, SOL)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Daily sleep diary for consecutive seven days.
Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of sleep diary measure (wake after sleep onset, WASO)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Daily sleep diary for consecutive seven days.
Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of sleep diary measure (sleep efficiency, SE)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Daily sleep diary for consecutive seven days.
Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, possible value range from 0-100%.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in Self-Report Chronotype Measures
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately.
The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in ADHD symptoms (Self-report)
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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The Adult ADHD Self-Report Scale (ASRS) v1.1 Symptom Checklist is an 18-item self-administered questionnaire to screen for ADHD symptoms in both community surveys and clinical settings based on criteria of the DSM-IV-TR.
The questionnaire asks participants to rate how often a symptom of inattention or hyperactivity has occurred during the past 6 months using a scale from 0 (never) to 4 (very often).
The total score on this scale can range from 0 to 72, with higher scores indicating more ADHD symptomology.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in subjective neuropsychological difficulties
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Subjective awareness of neuropsychological difficulties measured by the Subjective Awareness of Neuropsychological Deficits Questionnaire for Children (SAND-C).
This self-rated measure assesses perceived cognitive difficulties in daily life.
The possible score ranges from 1-4.
Higher scores indicate a worse outcome, reflecting greater perceived neuropsychological difficulties.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in Self-report Mood Symptoms
Zeitfenster: Baseline, mid-treatment (week 2, week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety.
The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression.
Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety.
No additional computation will be made with the two subscores.
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Baseline, mid-treatment (week 2, week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of daytime fatigue
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms.
There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue.
A grand total score can be calculated by summing up the three sub scores.
A higher score represents a higher level of fatigue symptoms.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in daytime sleepiness
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in Depressive Symptoms (Assessor-rated)
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semistructured interview with children.
Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in Objective Sleep Measures - Time in Bed (TIB)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Objective Sleep Measures - Total Sleep Time (TST)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Objective Sleep Measures - Sleep Onset Latency (SOL)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Objective Sleep Measures - Sleep Efficiency (SE)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, range from 0-100%
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - L5
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Circadian parameters computed by the nonparametric circadian rhythm analysis method - start times and average activity of L5 (i.e.
five hours with least activity).
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - M10
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Circadian parameters computed by the nonparametric circadian rhythm analysis method - start times and average activity of M10 (i.e. 10 h with maximal activity).
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - relative amplitude (RA)
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Circadian parameters computed by the nonparametric circadian rhythm analysis method - relative amplitude (RA), which is calculated using L5 and M10 to give a nonparametric description of amplitude.
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Actigraphic Circadian Measures using Cosinor Analysis - acrophase
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Circadian parameters computed by the cosinor analysis method - acrophase (the peak of the sine wave).
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Actigraphic Circadian Measures using Cosinor Analysis - amplitude
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Circadian parameters computed by the cosinor analysis method - amplitude (the difference between the wave peak and trough).
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Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
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Change in Actigraphic Circadian Measures using Cosinor Analysis - mesor
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Actigraphic assessment for consecutive seven days.
Circadian parameters computed by the cosinor analysis method - mesor.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in Objective Circadian Measures: Dim-light melatonin onset (DLMO)
Zeitfenster: Baseline and 1-month follow-up
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Dim-light melatonin onset (express as time value hh:mm) is determined by 10-hours salivary melatonin collected at 30-minutes interval.
Melatonin is assayed by gas chromatography-mass spectrometry.
Data will be collected in a subset of sample.
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Baseline and 1-month follow-up
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Change in neural sensitivity to light
Zeitfenster: Baseline, 1-month follow-up, and 6-month follow-up
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Neural sensitivity to light measured by pupillary light response (PLR).
PLR is based on change in pupil diameter in response to standardized light stimuli.
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Baseline, 1-month follow-up, and 6-month follow-up
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Change in impulsive decision-making
Zeitfenster: Baseline, 1-month follow-up, and 6-month follow-up
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Impulsive decision-making measured by the Delay Discounting Task (DDT).
This behavioural task assesses preference for smaller immediate rewards over larger delayed rewards.
Greater preference for larger delayed rewards indicates a better outcome, whereas steeper delay discounting indicates a worse outcome.
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Baseline, 1-month follow-up, and 6-month follow-up
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Change in decision-making under uncertainty
Zeitfenster: Baseline, 1-month follow-up, and 6-month follow-up
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Decision-making under uncertainty measured by the Beads Task.
This behavioural task assesses probabilistic reasoning and decision-making under uncertainty.
More adaptive evidence gathering before decision-making generally indicates a better outcome.
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Baseline, 1-month follow-up, and 6-month follow-up
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Change in information sampling and reflection impulsivity
Zeitfenster: Baseline, 1-month follow-up, and 6-month follow-up
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Information sampling and reflection impulsivity measured by the Information Sampling Task (IST).
This behavioural task assesses the amount of information gathered before making a decision.
Greater adaptive information sampling generally indicates a better outcome.
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Baseline, 1-month follow-up, and 6-month follow-up
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Change in working memory
Zeitfenster: Baseline, 1-month follow-up, and 6-month follow-up
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Working memory measured by the Digit Span Task.
This test assesses verbal short-term memory and working memory capacity.
Higher scores indicate a better outcome.
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Baseline, 1-month follow-up, and 6-month follow-up
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Change in sustained attention
Zeitfenster: Baseline, 1-month follow-up, and 6-month follow-up
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Sustained attention measured by the Continuous Performance Task (CPT).
This test assesses the ability to maintain attention to target stimuli over time.
Better accuracy and fewer omission and commission errors indicate a better outcome.
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Baseline, 1-month follow-up, and 6-month follow-up
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Change in ERP components on the Cued Go/NoGo task
Zeitfenster: Baseline, 1-month follow-up
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The ERP components including CNV, NoGo N2, and NoGo P3 will be examined between the treatment group and control, in baseline, post-treatment and followup sessions.
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Baseline, 1-month follow-up
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Change in ERP components on the Balloon Analogue Risk Task
Zeitfenster: Baseline, 1-month follow-up
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The ERP components including feedback-related negativity (FRN) and P300 amplitudes to both negative and positive feedback will be examined on the Balloon Analogue Risk Task.
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Baseline, 1-month follow-up
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Change in ERP components on the Stop Signal Task
Zeitfenster: Baseline, 1-month follow-up
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The ERP components, including N2 and P3 will be examined on the Stop Signal Task.
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Baseline, 1-month follow-up
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Remission of insomnia
Zeitfenster: One-week post-treatment, 1-month follow-up, and 6-month follow-up
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Remission of insomnia is measured by Insomnia Severity Index (ISI), possible scores range from 0 to 20, with a score less than 9 (ISI <9) defined as remission of insomnia.
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One-week post-treatment, 1-month follow-up, and 6-month follow-up
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Self-rated treatment response (insomnia)
Zeitfenster: One-week post-treatment, 1-month follow-up, and 6-month follow-up
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Treatment response for insomnia is defined as by a reduction of Insomnia Severity Index (ISI) score from baseline ≧ 6. ISI scores range from 0-20.
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One-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in subjective sleep quality
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Subjective sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).
The Pittsburgh Sleep Quality Index is a 19-item self-rated scale assessing sleep quality and sleep disturbances over the past month.
Possible global scores range from 0 to 21, with higher scores indicating a worse outcome.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in arousal predisposition
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Arousal predisposition measured by the Arousal Predisposition Scale (APS).
Possible scores range from 1 to 48.
Arousal Predisposition Scale is a self-rated scale assessing an individual's tendency to become aroused in response to internal or external stimuli.
Higher scores indicate greater arousal predisposition.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in Self-Report Circadian Typology
Zeitfenster: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-report rating scale measuring circadian preference (typology).
Possible scores range from 16 to 89, with lower scores indicating preference towards eveningness.
Based on the conventional cut off, having a Morningness-Eveningness Questionnaire score of 16-41 is considered eveningness.
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Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in self-report emotional states of depression, anxiety and stress
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Depression Anxiety Stress Scales (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three Depression Anxiety Stress Scales contains 14 items.
Scale score ranges from 0 to 42.
Higher scores suggest more depression, anxiety and stress, respectively.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in impulsive behavior
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Impulsive behaviour traits measured by the Short UPPS-P Impulsive Behavior Scale (SUPPS-P).
This self-rated scale assesses multiple facets of impulsive behaviour.
The Short UPPS-P Impulsive Behavior Scale (SUPPS-P) features a subscale score range of 4 to 16 for each of its five distinct impulsivity traits.
Higher scores indicate a higher level of impulsive behavior.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change in impulsivity
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Impulsiveness measured by the Barratt Impulsiveness Scale, Version 11 (BIS-11).
This self-rated scale assesses attentional, motor, and non-planning impulsiveness.
Possible total scores range from 30 to 120, with higher scores indicating higher impulsivity.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Change of Overall Severity of Clinical Symptoms
Zeitfenster: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluates the severity of psychopathology.
The score is given on a seven-point scale, with score ranging from 0-7, and higher values indicating higher severity of illness.
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Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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Treatment response (clinician-rated)
Zeitfenster: One-week post-treatment, 1-month follow-up, and 6-month follow-up
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Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Clinical Global Improvement Scale (CGI-I) evaluates change from the initiation of treatment.
Clinician rated treatment response score ranges from 0-7 and is defined as Clinical Global Improvement Scale score ≦ 2.
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One-week post-treatment, 1-month follow-up, and 6-month follow-up
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Shirley X Li, DClinPsy, The University of Hong Kong
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
10. August 2026
Primärer Abschluss (Geschätzt)
31. August 2029
Studienabschluss (Geschätzt)
31. August 2029
Studienanmeldedaten
Zuerst eingereicht
11. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. August 2026
Zuerst gepostet (Tatsächlich)
17. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EA260082
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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