A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury
Phase: NA
Conditions: Mild Traumatic Brain Injury, Post-Concussion Syndrome, Insomnia
Sponsor: University of Calgary

 
 
 
 
A pilot randomized clinical trial of cognitive-behavioural therapy for insomnia in adolescents 
with persistent post-concussion symptoms 
 
 
Date: September 19, 2018 

Supplement 1. 
Trial Protocol.  
 
Trial Design 
This study involved a single-blind, parallel-group randomized control trial design 
comparing CBT-I and a treatment as usual (TAU) control group. Eligible participants were 
randomly assigned to either the active treatment (CBT-I) or the TAU control group using a 
gender blocked computer-based randomization tool (https://www.randomizer.org/). Participants 
who were randomized to the TAU condition were offered CBT-I after all follow-up measures 
were completed. Researchers administering the assessments were blinded to the randomization 
results. The trial followed and is reported according to CONSORT guidelines 1. The outcome 
measures chosen were informed by recommendations for assessing outcome in insomnia trials, 
including assessment of potential secondary gains associated with treatment 2. The study 
received was approved by the University of Calgary Conjoint Health Research Ethics Board 
(REB16-1166). 
Participants and Procedures 
 
Participants were recruited from the Alberta Children’s Hospital (ACH) Brain Injury 
Clinic between October 2016 and August 2017. Adolescents were referred to the ACH Brain 
Injury Clinic based on persistent post-concussion symptoms. A total of 78 adolescents were 
approached, of whom 51 indicated interest in the study. Interested participants who could be 
contacted were screened for insomnia over the phone using the Insomnia Severity Index (ISI). If 
the potential participant received a score of ≥12 on the ISI, they were invited to attend a baseline 
session to determine eligibility. Of the participants who expressed interest in the study, 18 could 
not be reached for further screening and 9 did not meet the inclusion criteria. The final sample 

consisted of 24 youth who were randomized to CBT-I (n=12) or TAU (n=12). Participant flow is 
presented in Figure 1. 
Inclusion criteria included: (1) 12-18 years of age; (2) 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) 
3; (3) being at least 1 month but no more than 12 months post-injury to ensure symptoms were no 
longer acute, yet current and persistent; (4) reporting elevated symptoms of insomnia measured 
by an Insomnia Severity Index score of ≥12; and (5) ability to attend in-person treatment 
sessions. Exclusion criteria included: 1) 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); and 2) visual, hearing, motor, and/or language deficits that would hinder the completion 
of questionnaires or engagement in CBT-I.  
Assessments took approximately 45 minutes to complete and were conducted at baseline, 
post-treatment, and follow-up at four weeks after treatment. Assessments and treatment took 
place at the University of Calgary. In the first assessment at baseline, informed consent from the 
parent and informed assent from the adolescent were obtained in addition to baseline 
questionnaire data. If deemed eligible, participants were asked to fill out online sleep diaries for 
seven days. After the sleep diary was completed, participants were randomized to either CBT-I 
or TAU groups. If randomized to the CBT-I group, a study therapist contacted the participant 
and scheduled the first session. Seven weeks later, the post-treatment assessment was completed 
via online questionnaire and sleep diary. A third assessment was completed approximately four 

weeks after treatment (follow-up) via online questionnaire and sleep diary. A research 
coordinator who was blinded to group membership collected all data. After the third assessment 
was completed, participants in the TAU group were invited to take part in the six-week CBT-I 
treatment (additional outcome measures were not collected if they did so). Identical measures 
were completed at each time point, with the exception of demographics, which were collected 
only at baseline. At every assessment, participants were given a fifteen-dollar gift card for 
completing the online questionnaires and an additional five dollars for every day that they 
completed the online sleep diary, for a potential total of fifty dollars.  
Measures  
 
Demographics. Demographic information included age, date of birth, ethnicity, sex, 
height, weight, and concussion history.  
Insomnia Severity Index (ISI). The ISI is widely used to measure insomnia severity and 
treatment response in sleep research 4. The ISI is a seven-item self-report questionnaire that 
assesses sleep onset latency, sleep efficiency, and functional impact from sleep issues 4. 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. Although the ISI was originally designed 
for adults, it has been shown to be valid in adolescent populations 5-7. In a clinical sample, an ISI 
score ≥ 11 has been shown to have 97% specificity and 100% specificity to detect insomnia 4. 
The current study used a cut score of ≥12 for eligibility to maximize the likelihood that 
participants had clinically significant insomnia symptoms. The ISI total score was the primary 
outcome measure for treatment response.  

 
Pittsburgh Sleep Quality Index (PSQI). The PSQI is a widely used brief self-report 
measure of sleep quality aimed at examining the facets of sleep disturbance 8. 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 8. PSQI scores have adequate internal consistency 9. Additionally, the 
PSQI has shown validity for assessing sleep disturbances in adolescents following traumatic 
brain injury 9.  
Online 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. The 
perceived quality of sleep was collected by using a visual analog of a 5-point Likert scale 
ranging from 1 (very poor) to 5 (very good). Sleep diaries are a reliable estimate of sleep 
variables and considered a gold standard subjective sleep outcome 2,10. Sleep diaries have been 
used in other CBT-I studies with adolescents and have been shown to provide accurate sleep 
information in adolescent populations 11,12. 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.  

The 24-Hour Sleep Patterns Interview (SPI) was used to ensure sleep diary compliance 
and consistency. The SPI is a telephone interview that asks participants questions about sleep 
patterns over the past 24 hours, including bedtime, night wakening (frequency and duration), and 
overall sleep quality. The 24-hour sleep patterns interview was developed to corroborate 
actigraphy data, but for the purposes of this study was used to ensure adherence and consistent 
reporting of sleep diary data. Participants received a phone call from a research assistant on day 
two and day five of the 7-day sleep diary period and were asked to verify their responses for the 
prior morning entry. This measure has been shown to be valid and feasible compared with a 
sleep diary 13. 
Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16). 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 were summed to calculate a total raw score where higher scores indicate more negative 
beliefs and attitudes towards sleep. This scale identifies potential negative cognitions that can be 
held about sleep, such as the perceived consequences of insomnia, worry/helplessness about 
insomnia, general sleep expectations, and medications 14,15.  
Patient Reported Outcomes Measurement Information System (PROMIS®) 
Anxiety. 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 16,17. 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. The PROMIS® anxiety 
measure has been used in child, adolescent, and adult populations and has shown adequate or 
exceptional reliability 16,17.  
PROMIS® Depression. 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 16,17. 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. The 
PROMIS® depression measure has been used in child, adolescent, and adult populations and has 
shown adequate or exceptional reliability 16,17.  
Health and Behavior Inventory (HBI). The Health and Behavior Inventory (HBI) 18 
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 18. The HBI has 
strong internal reliability 19 and is identified as a core common data element for pediatric brain 
injury research by the National Institute of Neurological Disorders and Stroke (NINDS) 20.  
Treatment 

Participants in the treatment group received six weekly sessions of CBT-I. The protocol 
included psychoeducation about insomnia, relaxation strategies, instruction on sleep 
consolidation, stimulus control/sleep hygiene, cognitive restructuring, and problem 
solving/relapse prevention and mindfulness techniques. Sessions two through six began with a 
review of sleep diaries, calculation of sleep efficiency (SE), and troubleshooting of any problems 
encountered in home practice. This was followed by the introduction of new treatment 
components and a personal project for the next week. The protocol was based on CBT-I for 
adults 21 and was adapted for use with adolescents with concussion by the research team, which 
included an experienced CBT-I therapist (LTM). The initial adaptation was piloted in a group 
form, but based on feedback CBT-I was delivered individually in this trial.  
Manualized treatment was delivered by PhD students in clinical psychology, all of whom 
underwent a two-day training in delivery of CBT-I by the first author and were supervised 
weekly by a licensed PhD level clinical psychologist with experience in delivery of CBT-I and 
group supervision (JWM). A detailed description of the treatment by week is presented in Table 
1. Average number of sessions attended was 4.9 (SD = 2.2), with nine of twelve (75%) 
participants attending all six sessions.  
 
 
 
 
 
Insert Table 1 About Here 
 
 
 
 
 
Statistical Analysis  
All analyses were conducted using SPSS 25.0 22. Baseline demographic and medical 
variables for the two conditions were compared using one-way ANOVAs and χ2 tests. Intent-to-
treat (ITT) analyses were conducted in line with CONSORT guidelines (i.e., all participants who 

started the intervention were included) 1. ITT analyses were completed using maximum 
likelihood linear mixed model analyses. Between-group differences on primary and secondary 
outcome variables were also analyzed using linear mixed models. Linear mixed models are 
considered robust with respect to inclusion of participants with missing data in repeated 
measures research and are considered superior to traditional repeated measures ANOVA for 
longitudinal designs 23,24. Treatment group (CBT-I or TAU) was specified as the between-
subjects factor, and time of measurement was the within-subjects factor. The effect of interest 
was the treatment group by time interaction coefficient. Models were tested to include a linear 
and quadratic time coefficient; in final models the quadratic time coefficient was removed for all 
analyses in which it was not significant. Multiple structures were tested for sigma, and the 
identity structure was chosen because it provided the best Schwarz’s Bayesian Information 
Criterion (BIC) for each model. The treatment group variable was introduced as a dummy-coded 
variable with TAU as reference group. An α of 0.05 was used to determine statistical 
significance. Effect sizes of 0.20, 0.50, and 0.80 were interpreted as indicating small, medium, 
and large effects, respectively. Standardized effect sizes for linear mixed models were derived by 
calculating standard deviation (SD)pooled =√(((standard error [se]1*√n1)2 *(n1 –1)+(se2*√n2)2 
*(n2 –1))/(n1 +n2 –2)) based on existing recommendations 25-27.  
 
Other sleep data outcomes included change in PSQI, DBAS, and sleep diary measures. 
Most participants provided at least some sleep diary data. On average, participants provided data 
for 5.6 / 7 days at each assessment. Specifically, sleep diaries were completed by all 24 
participants at baseline (mean days of completion = 6.0), by 19 participants at post-treatment 
(mean days of completion = 5.0), and by 20 participants at the four-week follow-up (mean days 
of completion = 5.7). All available sleep diary data were included in analyses.  

Clinically significant change in ISI scores—the primary outcome variable—was also 
assessed in two ways. First, a variable indicating whether the ISI changed eight points or more 
was tested—a change of this magnitude is accepted as a meaningful change in CBT-I trials 28. 
Additionally, we calculated and analyzed the proportion of participants in each condition that 
reached a score below a cut-off of 8 (i.e., 0-7) on the ISI at each time point, indicative of 
“absence of insomnia” 29. To compare the proportion of participants who exhibited clinically 
significant change or reached a score below the cut-off, Fisher’s exact tests were used. 
 
 

Supplement Table 1. Structure of Cognitive-Behavioural Therapy for Insomnia (CBT-I) 
 
Session 1: Introduction 
1. Psychoeducation about insomnia and the CBT-I treatment including basic principles for 
coping with sleep problems 
2. Setting realistic sleep goals for treatment 
3. Discuss the importance of self-monitoring  
4. Practice using the Daily Sleep Diary 
 
Session 2: Relaxation Training 
1. Discuss the relationship between relaxation and sleep 
2. Review common relaxation practices 
3. Practice relaxation exercises in session 
 
Session 3: Stimulus, Sleep Consolidation and Medication Use 
1. Psychoeducation about stimulus control 
2. Review progress using sleep consolidation procedures and help adjust the sleep window 
3. Learn stimulus control procedures as a means of re-establishing a positive association 
between bed and sleeping 
4. Talk about steps to take control of sleep problems 
5. Review common sleep medications, uses and side effects 
 
Session 4: Cognitive Therapy 
1. Discuss the relationship between thoughts, feelings, and sleep behaviours. 
2. Review biased ways of thinking about sleep, signs that self-talk may be negative and self-
defeating and the categories of negative self-talk 
3. Examine attitudes and beliefs about sleep 
4. Identify and challenge participants’ negative self-talk about their sleep 
5. Discuss how worry may interfere with sleep and planning specific worry time  
 
Session 5: Sleep Hygiene 
1. Review the definition of sleep hygiene 
2. Discuss how diet/liquids, environment, exercise temperature and sleep-wake schedule 
can contribute to sleep 
 
Session 6: Mindfulness and Relapse Prevention 
1. Discuss mindfulness techniques as a way to improve insomnia 
2. Review common mindfulness practices in session 
3. Practice mindfulness exercises in session 
4. Emphasize the importance of maintaining treatment gains and continuing to work 
towards better sleep 
5. Discuss effective ways to cope with relapse 
 
 

References 
1. 
Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated 
guidelines for reporting parallel group randomized trials. Ann Intern Med. 
2010;152(11):726-732. 
2. 
Morin CM. Measuring outcomes in randomized clinical trials of insomnia treatments. 
Sleep Med Rev. 2003;7(3):263-279. 
3. 
McCrory P, Meeuwisse W, Dvorak J, et al. Consensus statement on concussion in sport-
the 5th international conference on concussion in sport held in Berlin, October 2016. Br J 
Sports Med. 2017. 
4. 
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: 
psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 
2011;34(5):601-608. 
5. 
Smith S, Trinder J. Detecting insomnia: comparison of four self-report measures of sleep 
in a young adult population. J Sleep Res. 2001;10(3):229-235. 
6. 
Gerber M, Lang C, Lemola S, et al. Validation of the German version of the insomnia 
severity index in adolescents, young adults and adult workers: results from three cross-
sectional studies. BMC Psychiatry. 2016;16:174. 
7. 
Chung KF, Kan KK, Yeung WF. Assessing insomnia in adolescents: comparison of 
Insomnia Severity Index, Athens Insomnia Scale and Sleep Quality Index. Sleep Med. 
2011;12(5):463-470. 
8. 
Buysse DJ, Reynolds CF, 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep 
Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 
1989;28(2):193-213. 

9. 
Fichtenberg NL, Putnam SH, Mann NR, Zafonte RD, Millard AE. Insomnia screening in 
postacute traumatic brain injury: Utility and validity of the Pittsburghe Sleep Quality 
Index. American Journal of Physical Medicine & Rehabilitation. 2001;80(5):339-345. 
10. 
Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for 
a standard research assessment of insomnia. Sleep. 2006;29(9):1155-1173. 
11. 
Palermo TM, Beals-Erickson S, Bromberg M, Law E, Chen M. A Single Arm Pilot Trial 
of Brief Cognitive Behavioral Therapy for Insomnia in Adolescents with Physical and 
Psychiatric Comorbidities. J Clin Sleep Med. 2017;13(3):401-410. 
12. 
Arora T, Broglia E, Pushpakumar D, Lodhi T, Taheri S. An investigation into the 
strength of the association and agreement levels between subjective and objective sleep 
duration in adolescents. PLoS One. 2013;8(8):e72406. 
13. 
Meltzer LJ, Mindell JA, Levandoski LJ. The 24-hour sleep patterns interview: a pilot 
study of validity and feasibility. Behav Sleep Med. 2007;5(4):297-310. 
14. 
Morin CM, Vallieres A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): 
validation of a brief version (DBAS-16). Sleep. 2007;30(11):1547-1554. 
15. 
Carney CE, Edinger JD, Morin CM, et al. Examining maladaptive beliefs about sleep 
across insomnia patient groups. J Psychosom Res. 2010;68(1):57-65. 
16. 
Irwin DE, Stucky B, Langer MM, et al. An item response analysis of the pediatric 
PROMIS anxiety and depressive symptoms scales. Qual Life Res. 2010;19(4):595-607. 
17. 
Irwin DE, Stucky BD, Thissen D, et al. Sampling plan and patient characteristics of the 
PROMIS pediatrics large-scale survey. Qual Life Res. 2010;19(4):585-594. 

18. 
Ayr LK, Yeates KO, Taylor HG, Browne M. Dimensions of postconcussive symptoms in 
children with mild traumatic brain injuries. Journal of the International 
Neuropsychological Society. 2009;15(1):19-30. 
19. 
Taylor HG, Dietrich A, Nuss K, et al. Post-concussive symptoms in children with mild 
traumatic brain injury. Neuropsychology. 2010;24(2):148-159. 
20. 
McCauley SR, Wilde EA, Anderson VA, et al. Recommendations for the use of common 
outcome measures in pediatric traumatic brain injury research. J Neurotrauma. 
2012;29(4):678-705. 
21. 
Vincent N, Lewycky S. Logging on for better sleep: RCT of the effectiveness of online 
treatment for insomnia. Sleep. 2009;32(6):807-815. 
22. 
IBM Corporation. IBM SPSS Statistics for Windows, Version 25.0. Armonk, N.Y.: 
Author; 2017. 
23. 
Gueorguieva R, Krystal JH. Move over ANOVA: progress in analyzing repeated-
measures data and its reflection in papers published in the Archives of General 
Psychiatry. Arch Gen Psychiatry. 2004;61(3):310-317. 
24. 
Nich C, Carroll K. Now you see it, now you don't: a comparison of traditional versus 
random-effects regression models in the analysis of longitudinal follow-up data from a 
clinical trial. J Consult Clin Psychol. 1997;65(2):252-261. 
25. 
Psychology Statistics. PSYSTAT (SPSS - General). 2018; 
http://www.psy.mq.edu.au/psystat/SPSSGeneral.html Accessed August 27, 2018. 
26. 
Dunlap WP, Cortina JM, Vaslow JB, Burke MJ. Meta-analysis of experiments with 
matched groups or repeated measures designs. Psychological Methods. 1996;1:170-177. 

27. 
Hedges LV. Effect sizes in cluster-randomized designs. Journal of Educational and 
Behavioral Statistics. 2007;32(341-370). 
28. 
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an 
outcome measure for insomnia research. Sleep Med. 2001;2(4):297-307. 
29. 
Morin CM. Insomnia: Psychological assessment and management. New York: The 
Guilford Press; 1993. 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain injury: A 
pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 2, 2016 
Page 1 of 1 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
1
 
 
 
 
 
 
ASSENT FORM FOR YOUNGER PARTICIPANTS (12-14 years) 
 
PROJECT TITLE: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic 
brain injury: A pilot randomized controlled trial using CBT-Insomnia 
 
PRINCIPAL INVESTIGATOR: Dr. Brian Brooks  
 
We want to tell you about a research study we are doing. A research study is a way to learn more about something. 
We would like to find out more about the best way to help kids who have had a concussion and are having trouble 
sleeping. We think that Cognitive-Behavioural Therapy for Insomnia might be a good way to help sleep problems. 
 
If you agree to join this study, you will be asked to answer questions about your sleep and your feelings, to 
participate in Cognitive-Behavioural Therapy for Insomnia for six weeks (one time per week), and then to answer 
the same questions again when the therapy is done and again one month later.  
 
Risks  
Some questions are tough and you may get frustrated when we give you hard questions. We will also ask you about 
your feelings and if you get sad you can talk to someone about them.  
 
Benefits 
Being in this study may not help you. But it can help other kids who hit their heads and are having trouble sleeping 
because we will know more about how to help treat their sleep problems.  
 
You do not have to join this study. It is up to you. You can say okay now and change your mind later. All you have 
to do is tell us you want to stop. No one will be mad at you if you don’t want to be in the study or if you join the 
study and change your mind later and stop.  
 
Before you say yes or no to being in this study, we will answer any questions you have. If you join the study, you 
can ask questions at any time. Just tell the researcher that you have a question. 
 
If you have any questions about this study please feel free to contact Dr. Brooks (403-955-2597).  
 
Would you like to be in this research study? 
 
 _____ Yes, I will be in this research study.   
   
 
_____ No, I don’t want to do this. 
 
We would like you to choose a fake name for yourself for us to use when contacting you. What fake name do you 
choose? 
 
 
Fake first name: ____________________ 
Fake surname: ____________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Child’s name 
 
 
Person obtaining assent  
Signature 
 
 
Date 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 1 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
1
 
 
 
 
 
CONSENT FORM 
 
TITLE: Treating sleep disturbance in adolescents who have protracted recovery from a mild 
traumatic brain injury: A pilot randomized controlled trial using CBT-Insomnia 
 
SPONSOR: Clinical Research Grant, Cumming School of Medicine 
 
INVESTIGATORS:  
 
Principal Investigator:  
Dr. Brian L. Brooks, Pediatric Neuropsychologist; (403) 955-2597 
 
Co-Investigators:  
Dr. Lianne Tomfohr, Assistant Professor and Clinical Psychologist 
Dr. Karen M. Barlow, Pediatric Neurologist & Director of the Calgary Childhood Traumatic 
Brain Injury Program 
Dr. Keith Owen Yeates, Professor and Neuropsychologist 
 
This consent form is only part of the process of informed consent. It should give you the basic 
idea of what the research is about and what your participation will involve. If you would like 
more detail about something mentioned here, or information not included here, please ask. Take 
the time to read this carefully and to understand any accompanying information. You will 
receive a copy of this form. 
 
BACKGROUND 
 
Each year, 35,000 Canadian children and adolescents sustain a mild traumatic brain injury 
(mTBI) (also called a concussion). 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 an mTBI. 
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.  
 
 
 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 2 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
2
WHAT IS THE PURPOSE OF THE STUDY? 
 
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 slow recovery from 
their mTBI. This represents a novel treatment option for this patient population and is anticipated 
to improve outcomes and quality of life.  
 
WHAT WOULD WE HAVE TO DO? 
 
If you choose to participate in this study, you will be asked to do the following: 
 
Week 1: At the start of the study, you will be interviewed about your sleep problems, and if 
eligible for the study, will fill out questionnaires about your sleep, symptoms, any pain, mood, 
and worrying. Questionnaires will take 30 minutes and will be done electronically. You will also 
complete a sleep diary, which takes about 5 minutes per day, and will be done online. Your 
parent will also fill out questionnaires about your sleep, mood and worrying, as well as 
demographic information. Parent questionnaires will take about 10 minutes to complete and are 
also done electronically.  
 
Weeks 2-7: In this study, you will be “randomized” into one of the two study groups described 
as follows. “Randomized” means that you will be put into a treatment group by chance, like 
flipping a coin. If you are selected for treatment, you will participate in six weekly sessions that 
involve the treatment strategy called cognitive-behavioural therapy for insomnia (CBT-I).These 
sessions will be delivered in-person at the University of Calgary. The therapy sessions will be led 
by a clinical psychology graduate student who has experience in providing this therapy. The 
therapy will be supervised by a registered psychologist (Dr. Tomfohr-Madsen). Each week, you 
will also complete the sleep diary as part of the therapy, which will take about 5 minutes each 
time. If you are selected for the waitlist, you will not receive treatment at this time.  
 
Week 8: Seven weeks after the first assessment, you and your parent will fill out the same 
questionnaires electronically that were filled out at the start of the study. It will take about 30 
minutes for your questionnaires, 5-10 minutes for the parent questionnaires, and 5 minutes for 
the sleep diary each day.  
 
Week 12: Approximately one month after the first follow-up assessment, you and your parent 
will fill out the same questionnaires electronically that were filled out at the start of the study. It 
will take about 30 minutes for your questionnaires, 5-10 minutes for the parent questionnaires, 
and 5 minutes for the sleep diary each day. If you were selected for the waitlist group and are 
still experiencing problems with sleep, at this time, you will be invited to participate in six 
weekly sessions of CBT-I. 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 3 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
3
 
WHAT ARE THE RISKS? 
There are no identifiable risks associated with participation in this study. The treatment that you 
will receive has been previously used in helping people obtain better sleep. If you tell us that you 
are in danger of hurting someone, you are in danger of hurting yourself, or you are in danger of 
hurting others, we are required by law to ask you more questions to find out more about the 
situation, and see what steps need to be taken to keep you safe. If the situation is very serious 
that you are in danger of harming yourself, the safety steps might include making sure that you 
are taken to a hospital’s emergency department by ambulance. 
 
The online questionnaires are being administered using a program called Qualtrics©, which is an 
American software company that is subject to U.S. laws (including the USA PATRIOT 
Act).  Because the USA PATRIOT Act permits the government to look at data stored in their 
country, we will have you complete all questionnaires using a study ID number (not your name) 
and no identifiers will be included in the database or stored by Qualtrics (e.g., email addresses, 
IP addresses). 
 
We will contact you by either email or text message (SMS) through the booking and scheduling 
service called “Jane”. Jane is based in Canada, so the USA PATRIOT Act does not apply to 
Jane. With Jane, we can send you convenient reminders about any appointments you have with 
our study, and we can send you convenient web-links to our Qualtrics questionnaires, so you do 
not have to worry about mailing them to us. As a precaution, we would like you to choose a fake 
name (pseudonym/alias/nick-name) that we would use to contact you through Jane. 
 
 
The fake name (pseudonym/alias/nick-name) I choose for myself is: 
 
 
Fake first name: ____________________ 
Fake surname: ____________________ 
 
I prefer to be sent reminders by: 
 
☐ Text message (SMS) 
 
☐Email 
 
 
ARE THERE ANY BENEFITS FOR ME? 
If you agree to participate in this study, there may or may not be a direct benefit to you. We hope 
that you will have improved sleep as a result of this treatment program. However, we do not 
know this yet, which is why we need to study the program with adolescents just like you. 
 
As far as we know, there are no medications or drugs that the government has said are safe for 
children and help them with their insomnia or sleeping problems in the long-term. Sometimes, 
doctors prescribe other hypnosis medications that were originally made for other problems. For 
children, it’s not recommended that these medications are used in the long-term, because 
researchers don’t know enough about how safe they are and how much they help. 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 4 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
4
DO WE HAVE TO PARTICIPATE? 
NO. Participation is voluntary and you and your parent may withdraw at any time. If you choose 
to withdraw, simply call the principal investigator (Dr. Brooks). If any new information becomes 
available that might affect your willingness to participate in the study, you will be informed as 
soon as possible. 
 
WHAT ELSE DOES OUR PARTICIPATION INVOLVE? 
Participation in this study involves engagement in a clinical treatment protocol to help with 
sleep. This means that you will participate in the treatment program and will have therapy-based 
tasks to complete each week. We will also ask parents to participate in the education session on 
week two of the treatment, as well as complete questionnaires (completed at start of treatment, 
end of treatment, and follow-up). 
 
We ask for your permission to audio and video record the clinical treatment sessions during your 
therapy visits to our lab. The recordings will allow the therapy supervisor, who is a registered 
psychologist (Dr. Tomfohr-Madsen), to ensure that the therapists are providing the same therapy 
in a reliable and standard manner. The recordings are confidential, and they will be stored in a 
secure location, will not be used for any other purpose, and will be erased afterwards. 
 
The recordings are completely voluntary, and you may decline to be video and/or audio 
recorded. Also, you can ask that the camera recorder be turned off at any time, and you can ask 
that the recording or any part of it be erased. Refusing to be video and/or audio recorded will not 
affect your participation in the study. 
 
WILL WE BE PAID FOR PARTICIPATING, OR DO WE HAVE TO PAY FOR 
ANYTHING? 
As a token of appreciation for participation and commitment to our study, you will be 
reimbursed $15 for each assessment questionnaire, and $5 for each day the sleep diary is filled 
out during the baseline and follow-up visits. This amounts to up to $50 per assessment (three 
assessments total). Any parking costs you or your parent incurs at the University of Calgary will 
be reimbursed. There is no cost for the in-person interventions. 
 
WILL MY RECORDS BE KEPT PRIVATE? 
Only the research team named above will have access to information collected. You and your 
parent will be given a study number to help protect your identity. This study ID will be used for 
all electronic questionnaires. The database of results will contain only your study identification 
number to make the data de-identified. All data will be kept on password-protected computers 
for at least ten years, as required by the University, before being destroyed. All research 
documents and computers will be stored in a locked filing cabinet in a locked office. You will 
not be identified by name in any reports of the completed study and all publications will be based 
on group information. The University of Calgary Conjoint Health Research Ethics Board will 
have access to the research records. 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 5 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
5
IF WE SUFFER A RESEARCH-RELATED INJURY, WILL WE BE COMPENSATED? 
In the event that you suffer injury as a result of participating in this research, no compensation 
will be provided to you by the Alberta Children’s Hospital Research Institute, the University of 
Calgary, the Alberta Health Services, or the Researchers. You still have all your legal rights. 
Nothing said in this consent form alters your right to seek damages. 
 
SIGNATURES 
 
Your signature on this form indicates that you have understood to your satisfaction the 
information regarding your participation in the research project and agree to participate as a 
participant. In no way does this waive your legal rights nor release the investigators or involved 
institutions from their legal and professional responsibilities. You are free to withdraw from the 
study at any time without jeopardizing your health care. If you have further questions concerning 
matters related to this research, please contact: 
 
Dr. Brian Brooks, principal investigator: (403) 955-2597 
 
If you have any questions concerning your rights as a possible participant in this research, please 
contact the Chair, Conjoint Health Research Ethics Board, University of Calgary at 403-220-
7990. 
 
 
Parent/Guardian’s Name 
 Signature 
 Date 
 
  
  
Child’s Name 
 Signature 
 Date 
 
  
 
 
Investigator/Delegate’s Name 
 Signature 
 Date 
 
  
  
Witness’ Name 
 Signature 
 Date 
 
The investigator or a member of the research team will, as appropriate, explain to your child the 
research and his or her involvement. They will seek your child’s ongoing cooperation throughout 
the study. 
 
The University of Calgary Conjoint Health Research Ethics Board has approved this research 
study. 
 
A signed copy of this consent form has been given to you to keep for your records and reference. 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 1 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
1
 
 
 
 
 
CONSENT FORM 
 
TITLE: Treating sleep disturbance in adolescents who have protracted recovery from a mild 
traumatic brain injury: A pilot randomized controlled trial using CBT-Insomnia 
 
SPONSOR: Clinical Research Grant, Cumming School of Medicine 
 
INVESTIGATORS:  
 
Principal Investigator:  
Dr. Brian L. Brooks, Pediatric Neuropsychologist; (403) 955-2597 
 
Co-Investigators:  
Dr. Lianne Tomfohr, Assistant Professor and Clinical Psychologist 
Dr. Karen M. Barlow, Pediatric Neurologist & Director of the Calgary Childhood Traumatic 
Brain Injury Program 
Dr. Keith Owen Yeates, Professor and Neuropsychologist 
 
This consent form is only part of the process of informed consent. It should give you the basic 
idea of what the research is about and what your participation will involve. If you would like 
more detail about something mentioned here, or information not included here, please ask. Take 
the time to read this carefully and to understand any accompanying information. You will 
receive a copy of this form. 
 
BACKGROUND 
 
Each year, 35,000 Canadian children and adolescents sustain a mild traumatic brain injury 
(mTBI) (also called a concussion). 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 an mTBI. 
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.  
 
 
 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 2 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
2
WHAT IS THE PURPOSE OF THE STUDY? 
 
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 slow recovery from 
their mTBI. This represents a novel treatment option for this patient population and is anticipated 
to improve outcomes and quality of life.  
 
WHAT WOULD WE HAVE TO DO? 
 
If you and your child choose to participate in this study, you will be asked to do the following: 
 
Week 1: At the start of the study, your child will be interviewed about their sleep problems, and 
if eligible for the study, will fill out questionnaires about their sleep, symptoms, any pain, mood, 
and worrying. Child questionnaires will take 30 minutes and will be done electronically. Your 
child will also complete a sleep diary, which takes about 5 minutes per day, and will be done 
online. We will also ask you to fill out questionnaires about your child’s sleep, mood and 
worrying, as well as demographic information. Parent questionnaires will take about 10 minutes 
to complete and are also done electronically.  
 
Weeks 2-7: In this study, your child will be “randomized” into one of the two study groups 
described as follows. “Randomized” means that they will be put into a treatment group by 
chance, like flipping a coin. Those selected for the treatment will participate in six weekly 
sessions that involve the treatment strategy called cognitive-behavioural therapy for insomnia 
(CBT-I). These sessions will be delivered in-person at the University of Calgary. The therapy 
sessions will be led by a clinical psychology graduate student who has experience in providing 
this therapy. The therapy will be supervised by a registered psychologist (Dr. Tomfohr-Madsen). 
Each week, your child will also complete the sleep diary as part of the therapy, which will take 
about 5 minutes each time. Those selected for the waitlist will not receive treatment at this time.  
 
Week 8: Seven weeks after the first assessment, you and your child will fill out the same 
questionnaires electronically that were filled out at the start of the study. It will take about 30 
minutes for child questionnaires, 5-10 minutes for the parent questionnaires, and 5 minutes for 
the sleep diary each day.  
 
Week 12: Approximately one month after the first follow-up assessment, you and your child will 
fill out the same questionnaires electronically that were filled out at the start of the study. It will 
take about 30 minutes for child questionnaires, 5-10 minutes for the parent questionnaires, and 5 
minutes for the sleep diary each day. If your child was selected for the waitlist group and is still 
experiencing problems with sleep, at this time, they will be invited to participate in six weekly 
sessions of CBT-I. 
 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 3 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
3
WHAT ARE THE RISKS? 
There are no identifiable risks associated with participation in this study. The treatment that your 
child will receive has been previously used in helping people obtain better sleep. If you tell us 
that you are in danger of getting hurt by someone, you are in danger of hurting yourself, or you 
are in danger of hurting others, we are required by law to ask you more questions to find out 
more about the situation, and see what steps need to be taken to keep you or your child safe. If 
the situation is very serious that you or your child are in danger of harming yourselves, the safety 
steps might include making sure that you are taken to a hospital’s emergency department by 
ambulance. 
 
The online questionnaires are being administered using a program called Qualtrics©, which is an 
American software company that is subject to U.S. laws (including the USA PATRIOT 
Act).  Because the USA PATRIOT Act permits the government to look at data stored in their 
country, we will have you complete all questionnaires using a study ID number (not your name) 
and no identifiers will be included in the database or stored by Qualtrics (e.g., email addresses, 
IP addresses). 
 
We will contact you by either email or text message (SMS) through the booking and scheduling 
service called “Jane”. Jane is based in Canada, so the USA PATRIOT Act does not apply to 
Jane. With Jane, we can send you convenient reminders about any appointments you have with 
our study, and we can send you convenient web-links to our Qualtrics questionnaires, so you do 
not have to worry about mailing them to us. As a precaution, we would like you to choose a fake 
name (pseudonym/alias/nick-name) that we would use to contact you through Jane. 
 
The fake name (pseudonym/alias/nick-name) I choose for myself is: 
 
 
Fake first name: ____________________ 
Fake surname: ____________________ 
 
I prefer to be sent reminders by: 
 
☐ Text message (SMS) 
 
☐Email 
 
 
ARE THERE ANY BENEFITS FOR MY CHILD? 
If you and your child agree to participate in this study, there may or may not be a direct benefit 
to you. We hope that your child will have improved sleep as a result of this treatment program. 
However, we do not know this yet, which is why we need to study the program with adolescents 
just like your child. 
 
To the best of our knowledge, there appears to be no Food and Drug Administration (FDA) -
approved medications/pharmacotherapy that is effective in the long-term, efficacious and safe for 
use with children. Despite this, medications/pharmacotherapy, such as hypnotic medications, 
have been prescribed off-label to children to treat sleep disruption in the short-term; long-term 
use is not recommended as little evidence exists regarding efficacy and safety. 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 4 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
4
DO WE HAVE TO PARTICIPATE? 
NO. Participation is voluntary and you and your child may withdraw at any time. If you choose 
to withdraw, simply call the principal investigator (Dr. Brooks). If any new information becomes 
available that might affect your willingness to participate in the study, you will be informed as 
soon as possible. 
 
WHAT ELSE DOES OUR PARTICIPATION INVOLVE? 
Participation in this study involves engagement in a clinical treatment protocol to help with 
sleep. This means that your child will participate in the treatment program and will have therapy-
based tasks to complete each week. We will also ask parents to participate in the education 
session on week two of the treatment, as well as complete questionnaires (completed at start of 
treatment, end of treatment, and follow-up). 
 
We ask for your permission to audio and video record the clinical treatment sessions during your 
therapy visits to our lab. The recordings will allow the therapy supervisor, who is a registered 
psychologist (Dr. Tomfohr-Madsen), to ensure that the therapists are providing the same therapy 
in a reliable and standard manner. The recordings are confidential, and they will be stored in a 
secure location, will not be used for any other purpose, and will be erased afterwards. 
 
The recordings are completely voluntary, and you may decline to be video and/or audio 
recorded. Also, you can ask that the camera recorder be turned off at any time, and you can ask 
that the recording or any part of it be erased. Declining to be video and/or audio recorded will 
not affect your participation in the study. 
 
WILL WE BE PAID FOR PARTICIPATING, OR DO WE HAVE TO PAY FOR 
ANYTHING? 
As a token of appreciation for participation and commitment to our study, your child will be 
reimbursed $15 for each assessment questionnaire, and $5 for each day the sleep diary is filled 
out during the baseline and follow-up visits. This amounts to up to $50 per assessment (three 
assessments total). Any parking costs you incur at the University of Calgary will be reimbursed. 
There is no cost for the in-person interventions. 
 
WILL MY RECORDS BE KEPT PRIVATE? 
Only the research team named above will have access to information collected. You and your 
child will be given a study number to help protect your identity. This study ID will be used for 
all electronic questionnaires. The database of results will contain only your study identification 
number to make the data de-identified. All data will be kept on password-protected computers 
for at least ten years, as required by the University, before being destroyed. All research 
documents and computers will be stored in a locked filing cabinet in a locked office. You will 
not be identified by name in any reports of the completed study and all publications will be based 
on group information. The University of Calgary Conjoint Health Research Ethics Board will 
have access to the research records. 
 

 
Ethics ID: REB16-1166 
Study Title: Treating sleep disturbance in adolescents who have protracted recovery from a mild traumatic brain 
injury: A pilot randomized controlled trial using CBT-Insomnia 
PI: Dr. Brian L. Brooks 
Version number/date: November 8, 2016 
Page 5 of 5 
 
CHREB Template March 2015 
 
Participant’s Initials:  _______________ 
5
IF WE SUFFER A RESEARCH-RELATED INJURY, WILL WE BE COMPENSATED? 
In the event that you or your child suffers injury as a result of participating in this research, no 
compensation will be provided to you by the Alberta Children’s Hospital Research Institute, the 
University of Calgary, the Alberta Health Services, or the Researchers. You still have all your 
legal rights. Nothing said in this consent form alters your right to seek damages. 
 
SIGNATURES 
 
Your signature on this form indicates that you have understood to your satisfaction the 
information regarding your participation in the research project and agree to participate as a 
participant. In no way does this waive you or your child’s legal rights nor release the 
investigators or involved institutions from their legal and professional responsibilities. You are 
free to withdraw from the study at any time without jeopardizing your health care. If you have 
further questions concerning matters related to this research, please contact: 
 
Dr. Brian Brooks, principal investigator: (403) 955-2597 
 
If you have any questions concerning your rights as a possible participant in this research, please 
contact the Chair, Conjoint Health Research Ethics Board, University of Calgary at 403-220-
7990. 
 
 
Parent/Guardian’s Name 
 Signature 
 Date 
 
  
  
Child’s Name 
 Signature 
 Date 
 
  
 
 
Investigator/Delegate’s Name 
 Signature 
 Date 
 
  
  
Witness’ Name 
 Signature 
 Date 
 
The investigator or a member of the research team will, as appropriate, explain to your child the 
research and his or her involvement. They will seek your child’s ongoing cooperation throughout 
the study. 
 
The University of Calgary Conjoint Health Research Ethics Board has approved this research 
study. 
 
A signed copy of this consent form has been given to you to keep for your records and reference.