Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth: a Randomised, Assessor Blind, Parallel Group Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Change of self-report mood symptoms
研究概览
简要总结
Major depressive disorder (MDD) is among the most common psychiatric disorders among adolescents, and is associated with considerable psychosocial and functional impairments and an elevated risk of suicidal behaviour and completed suicide. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in adolescents with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. This project will involve a randomised controlled trial proposed to examine whether insomnia treatment confers additional benefit to depression treatment in adolescents with comorbid depression and insomnia, for improving sleep and depressive symptoms, and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term. Eligible adolescent participants will be randomised to either intervention (8-week group Cognitive Behavioural Therapy for Insomnia, CBT-I, or 8-week group Cognitive Behavioural Therapy for Depression, CBT-D) or waiting-list control condition. Assessments will be conducted at pre-treatment (week 0), during the treatment (week 2, 4, 6) and post-treatment (week 8/at the conclusion of the last group session). The two active treatment groups will be additionally followed up at posttreatment one-month and six-month.
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 into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- •Being able to comply with the study protocol;
- •Having a DSM-V diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >=9; AND a DSM-V diagnosis of depressive disorder
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 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 DISP;
- •Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- •In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
- •Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- •Initiation of or change in antidepressant medication within past 2 months;
- •Having been or is currently receiving any structured psychotherapy;
- •With hearing or speech deficit;
- •Night shift worker.
结局指标
主要结局
Change of self-report mood symptoms
时间窗: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores.
Change of depressive symptoms (assessor-rated)
时间窗: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semistructured interview with children. Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.
Change of insomnia symptoms
时间窗: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
次要结局
- Change of sleep diary measure (wake after sleep onset, WASO)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective sleep measure (time in bed, TIB)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of sleep quality(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (total sleep time, TST)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (sleep efficiency, SE)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of daytime fatigue(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective cognitive performance (episodic memory)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of dysfunctional beliefs and attitudes about sleep(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (time in bed, TIB)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (sleep onset latency, SOL)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective sleep measure (sleep onset latency, SOL)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective sleep measure (sleep efficiency, SE)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of suicidal ideation(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective sleep measure (wake after sleep onset, WASO)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (problem solving)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of sleep hygiene and practice(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective sleep measure (total sleep time, TST)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (inhibitory ability)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of risk-taking & decision making(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of pre-sleep arousal(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective cognitive performance (working memory by digit span)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (working memory by N-Back)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of daytime sleepiness(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of quality of life(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of subjective cognitive performance(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (visual attention & task switching)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of sleep related attention bias(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of overall severity of clinical symptoms(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
研究者
Dr. Shirley Xin Li
Assistant Professor
The University of Hong Kong