Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury; Post-Concussion Syndrome; Insomnia
MeSH terms: Brain Injuries; Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Wounds and Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Cognitive Behavioural Therapy for Insomnia
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioural Therapy for Insomnia (CBT-I) consists of six individual therapy sessions that last approximately one hour each. The sessions include psychoeducation about insomnia, goal setting, relaxation training, stimulus control, sleep consolidation and medication review. Additional components include cognitive therapy, sleep hygiene and mindfulness and relapse prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment