Effects of CBT-I on Impulsivity and Risk Taking in Youths With Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-24
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioural Therapy for Insomnia
BehavioralCBT-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 interventionThe 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.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: CBT-IExperimental treatment 1 intervention
Group B: Health-related Psychoeducation controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov