An interventional study of Cognitive Behavioural Therapy for Insomnia and Health-related Psychoeducation in Insomnia, Impulsivity and Risk-Taking, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
Insomnia is prevalent in adolescents. Impulsive behaviours and excessive risk-taking have been linked to the manifestation of psychopathology in youths. Previous research based on behavioural and neurophysiological measures has found that individuals with insomnia demonstrated impaired inhibitory control, which is associated with detrimental outcomes such as substance abuse and self-harm.
Existing evidence has shown some positive effects of cognitive behavioural therapy for insomnia (CBT-I) on insomnia symptoms and daytime functioning in youths. Given the link between insomnia and impulsivity reported in previous research, and sleep as a highly modifiable factor, we are conducting this randomised controlled trial to examine the impact of CBT-I in improving impulsivity and risk-taking in youth with insomnia.
A randomised, assessor-blind, parallel-group controlled trial will be conducted on youths with insomnia. The study aims to test the effects of CBT-I on impulsivity in adolescents, as assessed through both self-report and objective measures when compared with the psychoeducation control. Eligible participants will be randomised to either group-based CBT-I or psychoeducation control condition. Randomisation will be carried out using an automated online system. Assessments will be conducted at pre-treatment (week 0) and post-treatment (week 7/one-week after the last group session), as well as post-treatment 6 months in order to examine the maintenance effects following the CBT-I intervention.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Clinically significant
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N = 62
Behavioral: Cognitive Behavioural Therapy for Insomnia
N = 62
Other: Health-related Psychoeducation
CBT-I consists of 6 weekly group sessions (90-min, 5-8 adolescents in each group) delivered in the afternoon/evening after school within a 10-week window. The intervention is structured and based on the well-established CBT elements for treating insomnia. The treatment components aim to address the behavioural, cognitive, and physiological factors perpetuating insomnia whilst considering the sleep and circadian features in adolescents and developmental context with the following key elements: psychoeducation about sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.
The active control group will receive group-based health-related psychoeducation, a format that has been adopted in the previous research, in order to provide the credibility of the intervention to the participants, and to control for the potential effects of attention and nonspecific components, e.g., receiving health-related information, expectations of benefit. It will also consist of 6 weekly sessions which contain education on general well-being, diet, and exercise/activity.
Change in Impulsivity
Change in the degree of impulsivity is the degree will be measured by UPPS-P Impulsive Behavior Scale.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change in Insomnia Symptoms
Insomnia symptoms are measured by the Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Sleep Diary Measure - Time in Bed (TIB)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Sleep Diary Measure - Total Sleep Time (TST)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Sleep Diary Measure - Sleep Onset Latency (SOL)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Sleep Diary Measure - Sleep Efficiency (SE)
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, %.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Actigraphy- based Measure
Sleep-wake pattern will be objectively measured by 7-day wrist actigraphy (Actiwatch Spectrum, Philips Respironics). Sleep parameter estimated by actigraphy will include time in bed, total sleep time, sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Objective Cognitive Performance (Cued Go/NoGo)
The Cued Go/NoGo task is a spatial-cueing task with equal probability of Go and NoGo stimuli. In the beginning of each trial, a left or right pointing arrow is presented for 200ms as a cue, instructing the participants to attend to the cued location and ignore the other. Following interval varying from 1000-1200ms from cue offset, a target is presented for 200ms. Participants should respond to the plus sign '+' (Go) at the cued location (Attend-Go), whilst inhibit from responding to the letter 'x' (NoGo) at the cued location (Attend-NoGo). For any target appearing at the ignored location, participants should not respond to either the Go target (Ignore- Go) or the NoGo target (Ignore-NoGo). The percentage of errors in all the trials (total error), the percentage of errors in Attend-NoGo trials (commission errors, indicating inhibition error), and the reaction time in Attend-Go trials with accurate responses (reaction time).
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Objective Cognitive Performance (Balloon Analogue Risk Task)
In this task, participants are instructed to fill the balloon with air by selecting number of "pumps" on the dial. Once the number of pumps was selected, the balloon would automatically expand until the target pump number was reached or the balloon popped. Either a green square (indicative of a reward) or a red square and exploded balloon (indicative of loss) appeared after the pumps accompanied by an auditory feedback played 500ms after the visual feedback. Visual feedback lasted 1000ms followed by a 1000-1200ms crosshair and a 100ms blank screen before the next balloon was presented. The total points earned, balloon/trial number, and the explosion point for the last balloon were displayed at the bottom of the screen. After the feedback, a new uninflated balloon appeared on screen until a total of 60 balloons were completed.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Objective Cognitive Performance (Delay Discounting Task)
In the delay discounting task, participants are asked to choose between two options: an immediate smaller reward (e.g., $17 now) and a later larger reward (e.g., $20 in 5 months). The magnitude of the immediate smaller reward and the magnitude and delay of the later larger reward varies from trial to trial. The immediate smaller option is always smaller and earlier than the later larger option. Performance indicator: The area under the curve (AUC) method will be used to analyse the data. A smaller AUC value indicates a higher impulsive choice.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change of Objective Cognitive Performance (Information Sampling Task)
In the information sampling task, participants are presented with a matrix of 25 gray boxes and 2 larger colored panels (yellow and blue) at the bottom. When participants touch a gray box, it will open to show its color (yellow or blue). Participants are instructed to decide which color they think is in the majority. It is up to the participants how many boxes they would like to open before making the decision. There are two conditions, i.e., Fixed win condition and Decreasing Win condition, each consisting of 10 trials. Performance indicators: The mean probability of being correct at the point of decision (P correct), the mean number of boxes opened per trial, as well as discrimination and sampling errors will be analysed. The lower mean P correct reflects higher reflection impulsivity.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change in ERP components on the Cued Go/NoGo task
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.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
Change in ERP components on the Balloon Analogue Risk Task
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.
Time frame: Baseline, one week after the intervention and 6-month after the intervention
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