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NCT Number: NCT07399964

Effects of CBT-I on Impulsivity and Risk Taking in Youths With Insomnia

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.

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Key information

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

Location status: Recruiting

Location contact

Shirley Xin LI, DClinPsy, PhD

CONTACT

[email protected]

39177035

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese aged 12-24 years old
  • Written informed consent of participation in the study is given by the participant and his/her parent or guardian (for those aged under 18)
  • Willing to comply with the study protocol
  • Meeting the DSM-V diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)

Exclusion criteria

  • A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities
  • Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease)
  • Having a clinically diagnosed sleep disorder (other than insomnia disorder) that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria
  • Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter OTC medications (e.g. melatonin, Traditional Chinese Medicine, TCM)
  • In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt)
  • Currently receiving any psychological treatment for insomnia
  • With hearing or speech deficit
  • Night shift worker

Treatment and study plan

Cognitive Behavioural Therapy for Insomnia

Behavioral

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.

Health-related Psychoeducation

Other

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.

Primary outcomes

  1. Change in Impulsivity

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    Change in the degree of impulsivity is the degree will be measured by UPPS-P Impulsive Behavior Scale.

Secondary outcomes

  1. Change in Insomnia Symptoms

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

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

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours.

  3. Change of Sleep Diary Measure - Total Sleep Time (TST)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours.

  4. Change of Sleep Diary Measure - Sleep Onset Latency (SOL)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins.

  5. Change of Sleep Diary Measure - Sleep Efficiency (SE)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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, %.

  6. Change of Actigraphy- based Measure

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

  7. Change of Objective Cognitive Performance (Cued Go/NoGo)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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).

  8. Change of Objective Cognitive Performance (Balloon Analogue Risk Task)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

  9. Change of Objective Cognitive Performance (Delay Discounting Task)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

  10. Change of Objective Cognitive Performance (Information Sampling Task)

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

  11. Change in ERP components on the Cued Go/NoGo task

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

  12. Change in ERP components on the Balloon Analogue Risk Task

    Time frame: Baseline, one week after the intervention and 6-month after the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley Xin LI, DClinPsy, PhD

CONTACT

[email protected]

39177035

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong
  • King's College London

Registry information

Official study title

Effects of Cognitive Behavioural Therapy for Insomnia (CBT-I) on Impulsivity and Risk Taking in Youths With Insomnia: A Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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