Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT03688984|
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
|First Submitted Date ICMJE||September 13, 2018|
|First Posted Date ICMJE||September 28, 2018|
|Last Update Posted Date||September 28, 2018|
|Actual Study Start Date ICMJE||September 1, 2016|
|Actual Primary Completion Date||January 17, 2018 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Insomnia Severity Index (ISI) total score. [ Time Frame: 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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury|
|Official Title ICMJE||A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury|
|Brief 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.|
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.
To determine if CBT-I (in-person) improves sleep in adolescents with protracted recovery following a mTBI.
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.
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).
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Assessors will be blind to randomization condition.Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Cognitive Behavioural Therapy for Insomnia
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.
|Study Arms ICMJE||
|Publications *||Tomfohr-Madsen L, Madsen JW, Bonneville D, Virani S, Plourde V, Barlow KM, Yeates KO, Brooks BL. A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Insomnia in Adolescents With Persistent Postconcussion Symptoms. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E103-E112. doi: 10.1097/HTR.0000000000000504.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Actual Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||January 17, 2018|
|Actual Primary Completion Date||January 17, 2018 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||12 Years to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT03688984|
|Other Study ID Numbers ICMJE||REB16-1166|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||University of Calgary|
|Study Sponsor ICMJE||University of Calgary|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of Calgary|
|Verification Date||September 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP