Effects of CBT-I on Impulsivity and Risk Taking in Youths With Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioural Therapy for Insomnia, Health-related Psychoeducation.
- Who it may be relevant to
- Registry conditions: Insomnia, Impulsivity, Risk-Taking. Basic parameters: 12 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Cognitive Behavioural Therapy for Insomnia (CBT-I) on Impulsivity and Risk Taking in Youths With Insomnia: A Randomised Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Behavioral Cognitive Behavioural Therapy for Insomnia
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: ps - Other Health-related Psychoeducation
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 outcome measures
- Change in Impulsivity [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
Secondary outcome measures (12)
- Change in Insomnia Symptoms [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Sleep Diary Measure - Time in Bed (TIB) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Sleep Diary Measure - Total Sleep Time (TST) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Sleep Diary Measure - Sleep Onset Latency (SOL) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Sleep Diary Measure - Sleep Efficiency (SE) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Actigraphy- based Measure [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Objective Cognitive Performance (Cued Go/NoGo) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Objective Cognitive Performance (Balloon Analogue Risk Task) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Objective Cognitive Performance (Delay Discounting Task) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change of Objective Cognitive Performance (Information Sampling Task) [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change in ERP components on the Cued Go/NoGo task [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
- Change in ERP components on the Balloon Analogue Risk Task [Time frame: Baseline, one week after the intervention and 6-month after the intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kon — Hong Kong
Identifiers
NCT: NCT07399964 · EA230518