Mild Traumatic Brain InjuryNCT03688984
Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury
A study testing Cognitive Behavioural Therapy for Insomnia in people with Mild Traumatic Brain Injury and Post-Concussion Syndrome, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Post-Concussion Syndrome, Insomnia
- What is being tested?
- Cognitive Behavioural Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2016to 17 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury
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.
Read the 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).
- Being tested
- Cognitive Behavioural Therapy for Insomnia
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for InsomniaBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy for Insomnia | Experimental | Six sessions of in person Cognitive Behavioural Therapy for Insomnia (CBT-I) Receives: Behavioral: Cognitive Behavioural Therapy for Insomnia |
| Treatment As Usual | No intervention | Participants will receive regular care in the Treatment As Usual (TAU) condition. Participants will be offered CBT-I at the completion of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI) total score.
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.
Measured: Baseline to post-treatment (7-weeks later)
Secondary outcomes (10)
Insomnia Severity Index (ISI) total score.
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.
Measured: Baseline to follow-up (4-weeks later)
Pittsburgh Sleep Quality Index (PSQI) Global Score
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.
Measured: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Dysfunctional Beliefs about Sleep (DBAS-16) total score
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Sleep efficiency (SE) as assessed via 7-night sleep diary
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.
Measured: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
PROMIS® Depression Scale total score
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.
Measured: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
PROMIS® Anxiety Scale total score
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.
Measured: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Health and Behavior Inventory (HBI) total score
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.
Measured: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Sep 2016
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Brooks, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688984
- Sponsor's protocol ID
- REB16-1166
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data wil be published by the primary study team.
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.
PubMed 31246882
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03688984
- Acronym / sponsor ID
- REB16-1166
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy for Insomnia | Experimental | Behavioral: Cognitive Behavioural Therapy for InsomniaSix sessions of in person Cognitive Behavioural Therapy for Insomnia (CBT-I) |
| Treatment As Usual | No intervention | –Participants will receive regular care in the Treatment As Usual (TAU) condition. Participants will be offered CBT-I at the completion of the trial. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for InsomniaCognitive 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. | Behavioural | Cognitive Behavioural Therapy for Insomnia |
Primary outcome
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.
10 secondary outcomes
Insomnia Severity Index (ISI) total score.
Time frame: Baseline to follow-up (4-weeks later)
Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Dysfunctional Beliefs about Sleep (DBAS-16) total score
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
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)
PROMIS® Depression Scale total score
Time frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
PROMIS® Anxiety Scale total score
Time frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Health and Behavior Inventory (HBI) total score
Time frame: Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 31246882Tomfohr-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.
- Individual participant dataSharing planned: No. Data wil be published by the primary study team.
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Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Brooks, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Insomnia in people with Mild Traumatic Brain Injury and Post-Concussion Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) total score. (time frame: Baseline to post-treatment (7-weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.