Efficacy of Cognitive Behaviour Therapy for Insomnia (CBT-I) in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Change in Insomnia Symptoms
研究概览
简要总结
Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms, as well as overall functional improvement.
详细描述
A parallel-group, randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia. Eligible participants will be randomised to either CBT-I + UC or UC condition. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. A random subset of the sample (estimated 15 participants per group) will be assessed for sleep objectively using actigraphy for 7 consecutive days at baseline and one-week post-treatment. Participants in the control group will be offered CBT-I after 3-month follow-up. During the study period, all the participants will continue their regular clinical follow-ups with their attending psychiatrist for the prescription of psychotropic medication(s), if needed, for managing their ADHD and mental health condition. Prescription of any psychotropic medications of each participant during the trial will be reviewed and documented at baseline and at each follow-up.
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 (Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cantonese-speaking adolescent aged 12-18 years old;
- •A diagnosis of ADHD as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
- •Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥ 9 (suggested cut-off for adolescents);
- •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;
- •Those who are not on ADHD medication or have been stabilized on psychostimulant or nonstimulant ADHD medications (maintaining the optimal medication dosage for at least 6 months).
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, autism spectrum disorder, organic mental disorders, or intellectual disabilities;
- •Having a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe 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;
- •Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g., hypnotics, steroids), except for the use of psychostimulant medication for ADHD;
- •Receiving ongoing psychological treatment for sleep problems;
- •With hearing or speech deficit;
- •In the opinion of the research clinician, having a clinically significant suicidality (e.g., with suicidal ideation with a plan or a suicide attempt in the recent one month), and/or endorsing "nearly everyday" for item 9 (suicidal thoughts) in the Patient Health Questionnaire - 9 (PHQ-9).
研究组 & 干预措施
cognitive behaviour therapy for insomnia (CBT-I) + usual care (UC) group
The intervention for the CBT-I + UC group will involve five weekly 50-minute individual, face-to-face sessions of CBT-I. The treatment components aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia whilst considering the clinical context of ADHD and include: psycho-education about ADHD, 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.
干预措施: CBT-I + UC group (Behavioral)
UC group
Participants will continue their usual clinical follow-up and receive standard treatment at the clinic.
结局指标
主要结局
Change in Insomnia Symptoms
时间窗: Baseline, week 2&4 of the intervention, one-week post-treatment and post-treatment 3 month.
Insomnia symptoms measured by 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.
次要结局
- Change in Sleep Diary Measure - Time in Bed (TIB)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Sleep Diary Measure - Total Sleep Time (TST)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Objective Sleep Measures - Time in Bed (TIB)(Baseline and one-week post-treatment)
- Change in ADHD Symptoms (Self-report)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Sleep Diary Measure - Sleep Onset Latency (SOL)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Objective Sleep Measures - Sleep Efficiency (SE)(Baseline and one-week post-treatment)
- Change in anxiety symptoms (Self-report)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Objective Sleep Measures - Sleep Onset Latency (SOL)(Baseline and one-week post-treatment)
- Change in Internalising and Externalising Symptoms (Parent-rated)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in depressive symptoms (Self-report)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Sleep Diary Measure - Wake After Sleep Onset (WASO)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)(Baseline and one-week post-treatment)
- Change in Sleep Diary Measure - Sleep Efficiency (SE)(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Individual Beliefs and Attitude about Sleep(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Objective Sleep Measures - Total Sleep Time (TST)(Baseline and one-week post-treatment)
- Change in Adolescent Sleep Hygiene(Baseline, one-week post-treatment and post-treatment 3 month)
- Change in Quality of Life(Baseline, one-week post-treatment and post-treatment 3 month)
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong