A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI) total score.
研究概览
简要总结
A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.
详细描述
Mild traumatic brain injuries (mTBIs) in youth are a major public health issue. The vast majority of adolescents who sustain a mTBI will recover within a few months. Epidemiological studies of youth with mTBI who present to the emergency department suggest that roughly 80-85% of school-aged children and adolescents will recover symptomatically by 3 months post-mTBI. These recovery rates suggest that only a small proportion of children with mTBI will show a protracted recovery. Unfortunately, these children require considerable health care resources, miss a large amount of academic time, and suffer declines in quality of life. There is a paucity of evidence-based treatment for the constellation of problems displayed by those with protracted recovery from mTBI, with most current practices focusing on amelioration of specific symptoms using pharmacological agents.
Following a mTBI, sleep disruption is a commonly reported symptom. Blinman and colleagues reported symptom characteristics in adolescents who were admitted to the hospital following a mTBI. When rating symptoms during the initial hospitalization, 55% reported having trouble falling asleep and 54% reported sleeping less than usual. When asked again 2-3 weeks follow-up, 38% reported having trouble falling asleep and 22% reported sleeping less than usual. Of the 22 symptoms being rated at the 2-3 week follow-up, sleep issues had some of the highest mean symptom severity ratings. Although sleep problems are often endorsed acutely after the injury, true sleep disturbance likely has a slightly delayed onset compared to physical symptoms (e.g., headaches, dizziness). Eisenberg and colleagues suggested that sleep problems resolved gradually over time, but evidence suggests that they can persist in a sub-sample of children with mTBI, particularly if the sleep difficulties arise early in recovery.
Cognitive behavioural therapy for insomnia (CBT-I) represents a promising therapeutic option for sleep disruption following mTBI in youth. Although sleep disturbance is a common post-concussive problem, few treatment options are available. CBT-I has been shown to successfully treat insomnia in multiple populations and has been recommended as a first-line treatment for insomnia, because it shows superior long-term symptom reduction in comparison to both benzodiazepine and non-benzodiazepine drugs. Furthermore, meta-analyses support the effectiveness of CBT-I, with medium to large effect sizes for CBT-I on measures of subjective sleep both at the end of treatment and on follow-up. CBT-I is theorized to work similarly in adult and adolescent populations. Evidence suggests that the gains made from CBT-I persist over time and include shorter latency to fall asleep, fewer times of waking after sleep onset, and better sleep efficiency, as well as secondary improvements in child-reported depression and anxiety.
Objective:
To determine if CBT-I (in-person) improves sleep in adolescents with protracted recovery following a mTBI.
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)
盲法说明
Assessors will be blind to randomization condition.
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
- •12-18 years of age
- •diagnosed with a concussion by a nurse practitioner or physician at the ACH Complex Concussion Clinic (i.e., concussion was defined as an traumatic injury to the head, at least one reported symptom [e.g., dizziness, headache, nausea] at the time of the injury, and a Glasgow Coma Scale rating of ≥13/15 at 30 minutes after injury, or loss of consciousness <30 minutes, or post-traumatic amnesia <24 hours)
- •being at least 2 months but no more than 12 months post-injury to ensure symptoms were no longer acute, yet current and persistent
- •reporting elevated symptoms of insomnia measured by an Insomnia Severity Index score of ≥12
- •ability to attend in-person treatment sessions.
排除标准
- •moderate or severe TBI (i.e., Glasgow Coma scale rating of ≤12, loss of consciousness exceeding 30 minutes, and/or post-traumatic amnesia exceeding 24 hours)
- •visual, hearing, motor, and/or language deficits that would hinder the completion of questionnaires or engagement in CBT-I.
研究组 & 干预措施
Cognitive Behavioural Therapy for Insomnia
Six sessions of in person Cognitive Behavioural Therapy for Insomnia (CBT-I)
干预措施: Cognitive Behavioural Therapy for Insomnia (Behavioral)
Treatment As Usual
Participants will receive regular care in the Treatment As Usual (TAU) condition. Participants will be offered CBT-I at the completion of the trial.
结局指标
主要结局
Insomnia Severity Index (ISI) total score.
时间窗: Baseline to post-treatment (7-weeks later)
The ISI is a seven-item self-report questionnaire that assesses sleep onset latency, sleep efficiency, and functional impact from sleep issues. The sleep latency and efficiency items are rated on a 5-point Likert scale from 0 (none) to 4 (very severe). The remaining four items measure dissatisfaction, how noticeable sleep problems are to others, distress from sleep problems, and interference with daily functioning (all rated on 5-point Likert scales). Total scores on the ISI range from 0-28 with higher scores indicating more insomnia symptoms.
次要结局
- Insomnia Severity Index (ISI) total score.(Baseline to follow-up (4-weeks later))
- Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- Dysfunctional Beliefs about Sleep (DBAS-16) total score(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- Total sleep time (TST) as assessed via 7-night sleep diary.(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- Wake after sleep onset (WASO) as assessed via 7-night sleep diary(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- Sleep onset latency (SOL) as assessed via 7-night sleep diary(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- Sleep efficiency (SE) as assessed via 7-night sleep diary(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- PROMIS® Depression Scale total score(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- PROMIS® Anxiety Scale total score(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))
- Health and Behavior Inventory (HBI) total score(Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later))