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Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688984
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Calgary

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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Post-Concussion Syndrome Insomnia Behavioral: Cognitive Behavioural Therapy for Insomnia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors will be blind to randomization condition.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : January 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Behavioural Therapy for Insomnia
Six sessions of in person Cognitive Behavioural Therapy for Insomnia (CBT-I)
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.

No Intervention: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Insomnia Severity Index (ISI) total score. [ Time Frame: Baseline to follow-up (4-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.

  2. Pittsburgh Sleep Quality Index (PSQI) Global Score [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    The PSQI is a widely used brief self-report measure of sleep quality aimed at examining the facets of sleep disturbance. It is composed of 19 items that measure sleep disruptions in the month prior to questionnaire completion. The PSQI contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction, which are combined into a total sleep quality score. The total PSQI raw score ranges from 0 to 21, with higher scores representing worse sleep disturbance; scores of greater than 5 indicate clinically significant sleep disruption.

  3. Dysfunctional Beliefs about Sleep (DBAS-16) total score [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    The DBAS was developed to identify unhelpful beliefs about sleep, and is composed of 16 items organized on an 11-point Likert scale that ranges from 0 (strongly disagree) to 10 (strongly agree). All item scores are summed and averaged to calculate a total raw score where higher scores indicate more negative beliefs and attitudes towards sleep. Scores range from 0-10.

  4. Total sleep time (TST) as assessed via 7-night sleep diary. [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated.

  5. Wake after sleep onset (WASO) as assessed via 7-night sleep diary [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated.

  6. Sleep onset latency (SOL) as assessed via 7-night sleep diary [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated.

  7. Sleep efficiency (SE) as assessed via 7-night sleep diary [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated.

  8. PROMIS® Depression Scale total score [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    The pediatric PROMIS® Depression questionnaire was developed by the NIH to evaluate symptoms of depression, such as feelings of hopelessness, helplessness, and worthlessness in pediatric populations. The self-report version of the PROMIS® Depression questionnaire was included in this study. This 8-item measure queries depression symptom presentation based on the past seven days, with each item rated on a 5-point Likert scale ranging from 1 (never) to 5 (almost always). All items were summed to calculate a total raw score where higher scores indicate more severe depressive mood. symptomology.

  9. PROMIS® Anxiety Scale total score [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    The pediatric PROMIS® Anxiety questionnaire was developed by the National Institutes of Health (NIH) to evaluate symptoms of anxiety, such as feelings of fear, anxious misery, and hyperarousal in pediatric populations. The self-report version of the PROMIS® Anxiety questionnaire was included in this study. This 8-item measure queries anxiety symptom presentation based on the past seven days, with each item rated on a 5-point Likert scale ranging from 1 (never) to 5 (almost always). All item scores were summed to calculate a total raw score where higher scores indicate more severe anxiety symptomology.

  10. Health and Behavior Inventory (HBI) total score [ Time Frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) ]
    The Health and Behavior Inventory (HBI) was used to measure the presence and severity of post-concussive symptoms based on adolescent self-report. The HBI measures the frequency of common somatic and cognitive post-concussive complaints and does not include any sleep-related items. The HBI is a 20-item questionnaire where symptoms are rated on a 4-point Likert scale ranging from 1 (never) to 4 (often) based on frequency over the past week. All items were summed to calculate a total raw score where higher scores indicate more severe post-concussive symptoms. The HBI was developed as a measure for both child and parent-proxy reports of post-concussive symptoms in children.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688984


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Brian Brooks, PhD University of Calgary
  Study Documents (Full-Text)

Documents provided by University of Calgary:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03688984    
Other Study ID Numbers: REB16-1166
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data wil be published by the primary study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Sleep Initiation and Maintenance Disorders
Brain Concussion
Post-Concussion Syndrome
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating