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.
Hypotheses:
Primarily, the investigators hypothesize that in-person CBT-I will result in significant improvements in subjectively reported insomnia for adolescents with mTBI, over and above treatment as usual.
Secondarily, the investigators hypothesize that in-person CBT-I will result in significant improvements in subjective sleep quality, dysfunctional beliefs about sleep, and sleep diary measures for adolescents with mTBI, over and above treatment as usual.
Method:
Participants: Participants 12-18 years of age who are slow to recover from a mTBI will be recruited from the ACH Brain Injury Clinic (Dr. Barlow, Lisette Lockyer, Lisa Bodell) and from the ACH Neuropsychology Service (Dr.Brooks).
Procedure: This will be a single-blind parallel-group RCT that will block sex (1:1 ratio). Those in the control group who have insomnia at week 13 can be entered into the treatment at that time. Participants will be randomized and will complete pre-treatment measures at week 1. The questionnaires are expected to take 30 minutes to complete (ISI, PSQI, DBAS, HBI, and PROMIS). Those randomized to the treatment arm (in-person CBT-I) will partake in a 6-week CBT-I program adapted for adolescents, with each session taking 1 hour. A breakdown of what each CBT-I session comprises is found in the study protocol. Sessions will be led by a postdoctoral fellow or graduate student overseen by Drs. Tomfohr-Madsen or Madsen (registered psychologists). Following treatment, participants will complete the same measures again. The same measures will be completed once more at one month post-treatment to measure maintenance of sleep improvement. The control group will participate in all assessment points, and may choose to partake in the CBT-I protocol after the final assessment if sleep problems persist.
This will be a randomized clinical trial - participants randomized to the treatment condition will partake in the CBT-I intervention. There is one treatment arm - in-person CBT-I. Participants randomized to the control condition may elect to partake in the CBT-I intervention following completion of all follow-up measures if their sleep problems persist.
Participants will complete pre-treatment measures at baseline (week 1). The questionnaires are expected to take 30 minutes for adolescents to complete (ISI, PSQI, DBAS-16, HBI, PROMIS depression and anxiety scales), plus 5 minutes daily for the sleep diary to be completed. Parents will provide demographic information (5-10 minutes). Those randomized to the treatment condition will partake in a 6-week CBT-I program (in-person) adapted for adolescents, with each session taking 1 hour. Corroboration of engagement in the treatment will be based on sleep diary entries. Sessions will be led by a postdoctoral fellow or graduate student overseen by Drs. Madsen and Tomfohr-Madsen (registered psychologists). Following the intervention, participants in both conditions will complete the same measures again at week 8 (assessors will be blinded to the study condition). The same measures will be completed one more time at one month post-treatment to measure maintenance of sleep improvement (assessors again blinded to study condition).
