Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD, Insomnia, and Evening Chronotype
20 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
150
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Shirley X Li, DClinPsy
- Numero di telefono: 39177035
- Email: shirley.li@hku.hk
Luoghi di studio
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Hong Kong, Hong Kong
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong, Hong Kong,
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Contatto:
- Shirley Xin Li Dr., DClinPsy
- Numero di telefono: +852 3917-7035
- Email: shirley.li@hku.hk
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
No
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in insomnia severity
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in pre-sleep arousal
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Shirley X Li, DClinPsy, The University of Hong Kong
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
10 agosto 2026
Completamento primario (Stimato)
31 agosto 2029
Completamento dello studio (Stimato)
31 agosto 2029
Date di iscrizione allo studio
Primo inviato
11 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 agosto 2026
Primo Inserito (Effettivo)
17 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Disordini mentali
- Disturbi del sonno e della veglia
- Disturbi del neurosviluppo
- Disturbi del sonno, intrinseci
- Dissonnie
- Disturbi da deficit di attenzione e comportamento dirompente
- Disturbi dell'inizio e del mantenimento del sonno
- Disturbo da deficit di attenzione con iperattività
Altri numeri di identificazione dello studio
- EA260082
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .