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

NCT07399964 | Recruiting

• 1 other identifier: EA230518
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Impulsivity; Risk-Taking

Keywords

Insomnia; Youth; Impulsivity; Inhibitory Control

Outcome Measures

Primary Outcomes (1)

• Change in Impulsivity

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

  Baseline, one week after the intervention and 6-month after the intervention

Secondary Outcomes (12)

• Change in Insomnia Symptoms

  Baseline, one week after the intervention and 6-month after the intervention

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

  Baseline, one week after the intervention and 6-month after the intervention

• Change of Sleep Diary Measure - Total Sleep Time (TST)

  Baseline, one week after the intervention and 6-month after the intervention

• Change of Sleep Diary Measure - Sleep Onset Latency (SOL)

  Baseline, one week after the intervention and 6-month after the intervention

• Change of Sleep Diary Measure - Sleep Efficiency (SE)

  Baseline, one week after the intervention and 6-month after the intervention

Study Arms (2)

CBT-I

EXPERIMENTAL

N = 62

Behavioral: Cognitive Behavioural Therapy for Insomnia

Health-related Psychoeducation control

ACTIVE COMPARATOR

N = 62

Other: Health-related Psychoeducation

Interventions

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.

CBT-I

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.

Health-related Psychoeducation control

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• King's College London: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Impulsive Behavior; Risk-Taking

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Shirley Xin LI, DClinPsy, PhD

CONTACT

39177035; shirleyx@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 10, 2026
• Study Start: June 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

HK (1)