NCT06054243已完成不适用
Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia: A Randomised, Assessor Blind, Parallel-group Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Change of insomnia symptoms
研究概览
简要总结
Youth is an important transitional stage associated with dynamic changes in biological, cognitive, and psychological functioning, as well as a constellation of developmental and psychosocial challenges. In particular, anxiety disorders constitute the most common mental health problems in youth, with a prevalence rate up to 32%. Youth anxiety is associated with not only profound personal distress, but also considerable impairments in psychosocial functioning and an increased risk for developing other psychiatric comorbidities (e.g. depression, substance use). Meanwhile, sleep problems, particularly insomnia, are also common in the teen years, with a prevalence rate as high as 36%. Insomnia and anxiety are highly comorbid conditions, with increasing evidence suggesting their intricate, bidirectional relationship, such as a high level of anxiety symptoms found in youth with insomnia. However, optimal treatment strategies to manage the comorbidity of these two conditions remain uncertain. This study will test the efficacy of group-based cognitive behavioural therapy for insomnia (CBT-I) and cognitive behavioural therapy for anxiety (CBT-A) in reducing the severity of insomnia and anxiety symptoms in youth with comorbid insomnia and anxiety, as well as their effects on depressive symptoms, daytime functioning (e.g. sleepiness, fatigue), subjective and objective sleep measures.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Trial assessors and investigators are masked to group allocation.
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese aged 12-20 years old (an age range that was suggested by scholars to cover a wider developmental span in adolescence);
- •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-5 diagnostic criteria of insomnia disorder and with a score on the Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents); 5) Presenting with a high level of anxiety symptoms as defined by a total score >32 and >37 for males and females, respectively, on Spence Children's Anxiety Scale (SCAS).
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) 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 DISP, a validated structured diagnostic interview to assess major sleep disorders according to the 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);
- •Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- •Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed confirmed by research clinician;
- •Currently receiving any structured psychotherapy;
- •With hearing or speech deficit;
- •Night shift worker.
研究组 & 干预措施
CBT-A
Experimental
Cognitive behavioural therapy for anxiety, CBT-A: CBT-A intervention will consist of eight weekly group sessions (120-min, 4-6 adolescents in each group) delivered within a 10-week windows. T
干预措施: CBT-A (Behavioral)
CBT-I
Experimental
Cognitive behavioural therapy for insomnia, CBT-I: CBT-I intervention will consist of eight weekly group sessions (120-min, 4-6 adolescents in each group) delivered within a 10-week windows.
干预措施: CBT-I (Behavioral)
Waiting-list control
No Intervention
Participants will undergo a waiting period without any active intervention provided.
结局指标
主要结局
Change of insomnia symptoms
时间窗: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Insomnia Severity Index (ISI) is a 7-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.
Change of anxiety symptoms (assessor-rated)
时间窗: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale commonly used in the clinical studies on anxiety conducted in adolescents. Possible scores range from 0 to 35, with higher scores indicating severer anxiety symptoms.
次要结局
- Change of sleep diary measure (sleep onset latency, SOL)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change in chronotype preference(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
- Change of Repetitive Negative Thinking(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants)
- Change of objective sleep measure (sleep efficiency, SE)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep reactivity(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of overall severity of clinical symptoms(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective cognitive performance (risk-taking & decision making)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep quality(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep diary measure (wake after sleep onset, WASO)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of daytime sleepiness(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of mood symptoms(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of emotional states of depression, anxiety, and stress(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective cognitive performance (inhibitory ability)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep diary measure (time in bed, TIB)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep diary measure (total sleep time, TST)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep diary measure (sleep efficiency, SE)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective sleep measure (total sleep time, TST)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective sleep measure (sleep onset latency, SOL)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of dysfunctional beliefs and attitudes about sleep(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of pre-sleep arousal(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of sleep hygiene and practice(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of daytime hyperarousal(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective sleep measure (time in bed, TIB)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective sleep measure (wake after sleep onset, WASO)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of daytime fatigue(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change in sleep timing and chronotype(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
- Change in anxiety symptoms(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of state and trait anxiety(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of quality of life(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of objective physiological performance (attentional bias)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
- Change of suicidal ideation(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups)
- Change of Locus of Control(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants)
- Change of Sleep-related Locus of Control(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants)
- Change of objective cognitive performance (attentional bias)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
- Change of objective cognitive performance (working memory)(Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups)
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong
研究点 (2)
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