Effects of Cognitive Behavioural Therapy for Insomnia (CBT-I) on Impulsivity and Risk Taking in Youths With Insomnia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in Impulsivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
CBT-I
N = 62
干预措施: Cognitive Behavioural Therapy for Insomnia (Behavioral)
Health-related Psychoeducation control
N = 62
干预措施: Health-related Psychoeducation (Other)
结局指标
主要结局
Change in Impulsivity
时间窗: 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.
次要结局
- 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)
- Change of Actigraphy- based Measure(Baseline, one week after the intervention and 6-month after the intervention)
- Change of Objective Cognitive Performance (Cued Go/NoGo)(Baseline, one week after the intervention and 6-month after the intervention)
- Change of Objective Cognitive Performance (Balloon Analogue Risk Task)(Baseline, one week after the intervention and 6-month after the intervention)
- Change of Objective Cognitive Performance (Delay Discounting Task)(Baseline, one week after the intervention and 6-month after the intervention)
- Change of Objective Cognitive Performance (Information Sampling Task)(Baseline, one week after the intervention and 6-month after the intervention)
- Change in ERP components on the Cued Go/NoGo task(Baseline, one week after the intervention and 6-month after the intervention)
- Change in ERP components on the Balloon Analogue Risk Task(Baseline, one week after the intervention and 6-month after the intervention)
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong