Insomnia Treatment and Problems (the iTAP Study)
Phase: NA
Conditions: Insomnia, Alcohol; Harmful Use
Sponsor: University of Missouri-Columbia

 
 
 
 
 
 
 
 
 
 
 
Insomnia Treatment and Problems (The iTAP Study) 
University of Missouri IRB #2010684 
Protocol Date: 3/4/2019 
NCT03627832 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Protocol 
 
 
• Use the section headings to write the Protocol, inserting the appropriate material in 
each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting Protocol (new or revised), enter the date and version number to 
the field at the top of Protocol. 
 
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1. Abstract 
Heavy alcohol use is prevalent among young adults and results in significant physical and 
psychological burden. Despite wide implementation of alcohol risk reduction efforts on college 
campuses, rates of heavy alcohol consumption remain high, with 35% of students reporting 
consumption of 5+ drinks on the same occasion in the past 2 weeks. Thus, additional strategies 
are needed to reduce the burden of heavy alcohol use among young adults. More than half of 
heavy-drinking young adults report symptoms of insomnia. In turn, insomnia symptoms have 
been associated with increased risk of alcohol-related problems. The proposed project aims to 
reduce the burden of heavy alcohol use by examining the efficacy of Cognitive Behavioral 
Therapy for Insomnia (CBT-I) in reducing alcohol use and related problems among heavy-
drinking young adults. Twenty seven young adults who indicate risk for problem drinking on the 
Alcohol Use Disorders Identification Test (scores ≥4/5 for women/men) and meet DSM-5 
criteria for Insomnia Disorder will participate in a 6-week pilot trial. Participants will complete 
six individual sessions of CBT-I. Outcomes will be assessed at the end of the active intervention 
period (6 weeks) and 1 month post-intervention. Primary outcomes of interest include insomnia 
severity, total wake time, sleep quality, drinking quantity and frequency, and alcohol-related 
consequences. The proposed research aims to reduce the harms associated with heavy alcohol 
use among young adults by improving the availability of efficacious treatment. It will impact our 
understanding of the benefits of CBT-I, and it is innovative because it evaluates improvement in 
insomnia as a mechanism for improvements in alcohol use disorder (AUD). This research is 
consistent with the National Institute on Alcohol Abuse and Alcoholism’s initiative to evaluate 
and promote interventions that prevent the progression of AUD in diverse populations. It will 
enhance the stature of the university by improving our ability to compete successfully for federal 
funding to conduct high-quality research. 
 
2. Objectives (include all primary and secondary objectives) 
(1) To evaluate the effect of insomnia treatment on insomnia severity, total wake time, and 
sleep quality. 
(2) To evaluate preliminary treatment efficacy in reducing alcohol use and alcohol-related 
problems. 
 
3. Background 
Heavy alcohol use is a problem on college campuses, where 35% of students report consumption 
of 5 or more drinks on the same occasion in the past 2 weeks (Johnston, O'Malley, Bachman, 
Schulenberg, & Miech, 2015). This form of heavy drinking has been associated with a range of 

problems, from academic underperformance to sexual assault (Hingson, 2010). Given the 
prevalence and impact of heavy alcohol use within this population, evaluation and promotion of 
interventions that prevent the progression of alcohol use disorders among young adults is an 
ongoing focus of public health efforts.  
 
Sleep problems have been identified as prospective predictors of alcohol use in epidemiological 
studies of children, adolescents, and adults. Specifically, sleep problems in childhood predict the 
onset of alcohol use among adolescents (Wong, Brower, & Zucker, 2009), sleep problems in 
adolescence predict alcohol use and related problems among young adults (Pieters et al., 2015), 
and sleep problems in adulthood predict the onset of substance use disorders (Weissman, 
Greenwald, Nino-Murcia, & Dement, 1997). Thus, prevention and early intervention in sleep 
problems may delay onset of heavy substance use and prevent progression to problematic use. 
 
College is an important developmental time period in adolescent sleep, characterized by 
significantly later, more irregular bedtime, shorter sleep durations, and increased difficulty 
falling asleep (Gellis, Park, Stotsky, & Taylor, 2014; Lund, Reider, Whiting, & Prichard, 2010; 
Wolfson, 2010). In national studies, as many as 60% of young adults in college are classified as 
‘poor quality’ sleepers (Lund et al., 2010), and 10% meet criteria for chronic insomnia (Taylor, 
Bramoweth, Grieser, Tatum, & Roane, 2013). Unfortunately, in the case of alcohol use, drinking 
has also been associated with more alcohol-related problems in the context of inadequate sleep 
(Kenney, LaBrie, Hummer, & Pham, 2012; Miller, DiBello, Lust, Carey, & Carey, 2016). Thus, 
post-high school years may be a critical time to intervene in both sleep and alcohol use patterns 
among young adults, as the establishment of healthy lifestyles in college may minimize the long-
term harms associated with poor sleep and heavy alcohol use.  
 
Given the association between insomnia symptoms and alcohol-related consequences, treatment 
of sleep problems is expected to reduce heavy drinking and alcohol-related problems among 
young adults. Two previous studies have examined the effects of insomnia on alcohol use. 
Hershner and O’Brien (2016) found that an online sleep education intervention significantly 
improved sleep hygiene and reduced the likelihood of risky drinking (>10 drinks per week) 
among college students. In a separate trial, Fucito and colleagues (2017) found that an online 
sleep intervention incorporating personalized feedback on alcohol use reduced sleep impairment, 
drinks per week, and alcohol-related consequences; however, the evidence-based intervention 
did not improve sleep or alcohol-related outcomes significantly better than the general health 
education control. Both of these studies provide evidence that improving sleep patterns will 
reduce risk for alcohol-related problems; yet neither specifically targeted individuals with 
insomnia, nor did they utilize an empirically supported treatment. 
 
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first line of treatment for insomnia 
(Siebern & Manber, 2011). It has demonstrated efficacy in reducing symptoms of insomnia 
among young adults (Taylor et al., 2014), and effects are maintained in the presence of medical 
and psychiatric disorders (Smith, Huang, & Manber, 2005). However, no studies have examined 
the impact of CBT-I on alcohol-related outcomes among heavy-drinking young adults. 
 
4. Study Procedures 

This research will examine the efficacy of CBT-I in improving sleep and alcohol use outcomes 
among heavy-drinking young adults. Forty-four young adults will be randomized to receive sleep 
hygiene or to participate in six sessions of individual Cognitive Behavioral Therapy for Insomnia 
(CBT-I). Outcomes will be assessed at baseline, post-treatment, and 1 month follow-up (see 
Figure 1 below). 
 
Recruitment. Participants will be recruited through 
community advertising for treatment of insomnia in 
young adults. Flyers will be posted around campus and 
in local primary care and sleep clinics. We will also 
recruit using monthly emails through the MU email 
system and Facebook. Participants will have the option 
of (a) completing the screening survey online via 
Qualtrics or (b) calling project staff to learn more about 
the study. In a previous trial examining the efficacy of 
CBT-I among young adult college students who were not 
heavy drinkers (Taylor et al., 2014), prevalence was 10% 
and attrition was 15%. Assuming a similar attrition rate, 
we will recruit 6 participants per month for 10 months (n 
= 52) to obtain a final sample of 44 participants.  
 
Baseline assessment. Individuals who are interested in 
the study will complete a brief eligibility screen. Those 
who are eligible and interested will be scheduled for an 
intake assessment, during which they will provide informed consent, complete the Mini 
International Neuropsychiatric Interview (MINI) for DSM-5 with the RA, and complete baseline 
measures. At the end of the baseline assessment, the RA will provide all participants with a one-
page handout on sleep hygiene, which will include personalized normative feedback on their 
alcohol use. The RA will give the participant time to read the handout and will be available to 
answer questions, but will not engage the participant in unsolicited discussion about the 
information. The RA will then orient participants to the actiwatch (Philips Respironics) and the 
sleep diary.  
 
If participants endorse suicidal ideation during the baseline assessment (or at any assessment 
throughout the protocol), research staff will assess their suicidal ideation using the Suicidal 
Ideation Attributes Scale (SIDAS). All risk information will be shared in real time with the 
supervising licensed clinical psychologist, who will make a clinical judgment regarding the 
continued level of care required. If the supervising psychologist deems that the individual 
requires immediate on-site psychiatric evaluation, the participant will be escorted to the 
Psychiatric Center’s Emergency Room (located in the same building as the Department of 
Psychiatry) for an in-person, comprehensive evaluation. 
 
At-home assessment. Participants will be asked to wear the actiwatch 24/7 and complete one full 
week of daily sleep diaries to confirm diagnosis of insomnia (>30min sleep onset latency or 
wake after sleep onset 3+ nights per week). Sleep diaries will be collected electronically and 
time-stamped each morning using the Qualtrics data management system. Participants will be 

asked to complete the diary each morning before noon. Those who have not completed the diary 
by noon will receive a reminder text or phone call from study staff.  
 
Randomization. Participants who are eligible based on the week of at-home assessment will be 
block randomized to the CBT-I or sleep hygiene only conditions.  
 
Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I 
condition will attend 1-hour individual sessions of CBT-I once a week for six weeks. The study 
therapist will follow the CBT-I protocol implemented in previous efficacious trials of CBT-I 
with college students (Taylor et al., 2014). Consistent with clinical guidelines (Schutte-Rodin, 
Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use 
of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep 
restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene 
(e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), 
relaxation training, and cognitive restructuring. All patient interactions will be conducted under 
the weekly supervision of PI Miller, a licensed clinical psychologist who specializes in addiction 
treatment. In turn, PI Miller will be supervised by co-I McCrae, a licensed clinical psychologist 
who is board certified in behavioral sleep medicine.  
 
Sleep hygiene. All participants will receive a one-page handout on sleep hygiene that includes 
personalized normative feedback on their alcohol use. This is the only intervention that 
participants assigned to the Sleep Hygiene condition will receive and is consistent with what may 
be expected as standard care in a doctor’s visit with a primary care physician. We did not include 
a control condition that was matched with CBT-I for time and content, given our focus on 
preliminary outcomes. 
 
Personalized normative feedback on alcohol use. As part of the sleep hygiene recommendations, 
participants will receive personalized normative feedback on their alcohol use. Normative 
feedback will be modeled after previously utilized, efficacious interventions (Neighbors, 
Larimer, & Lewis, 2004). Feedback will portray a bar graph and explanatory text comparing 
personal drinking quantity to that of same-sex peers. 
 
Follow-up assessments. At the end of treatment and 1 month after treatment, follow-up 
assessments will be administered in person by the RA. To enhance follow-up rates, participants 
will receive $20 for completion of the baseline assessment, $5 for on-time completion of each 
week of daily diaries (potential to earn $30), $25 for the post-treatment assessment, $25 for the 
one-month follow-up.  
 
Blinding. PI Miller will not be blinded to block size or participant assignment because she will 
inform study therapists of participant assignment to conditions. However, PI Miller and study 
therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to 
participant condition. All participants will be told that they received a promising treatment for 
insomnia in order to blind them to condition assignment.  
 
Treatment integrity. Treatment integrity will be assured in three steps. (1) Delivery. The study 
therapist will receive training in use of the treatment manual via audio-recorded mock therapy 

sessions. PI Miller and co-I McCrae, both of whom are licensed clinical psychologists, will 
evaluate audiotapes of mock sessions and provide corrective feedback. All intervention sessions 
will be audio-recorded, given participant permission. PI Miller and co-I McCrae, who is board 
certified in behavioral sleep medicine, will review session audiotapes for ongoing training and 
supervision. PI Miller will score five randomly selected tapes to assess treatment fidelity using a 
checklist of treatment elements. Descriptive analyses will be used to determine the proportion of 
intended treatment elements covered in intervention sessions. (2) Comprehension. Participants 
will be provided with a workbook detailing treatment instructions, rationale, and handouts and 
encouraged to ask questions. (3) Enactment. Workbooks will contain written instructions on 
home assignments, and therapists will encourage assignment completion.  
 
Early termination. All participants will receive sleep hygiene recommendations and personalized 
feedback on their alcohol use immediately following baseline assessment, so every participant 
who attends baseline will receive some form of treatment for insomnia and heavy drinking. 
However, participants may decide to stop participating in the study at any time without penalty. 
If they decide to withdraw their participation, therapy will be terminated. This will be discussed 
as part of the informed consent process.  
 
5. Inclusion/Exclusion Criteria 
Eligibility criteria include (a) age 18 to 30 years, (b) heavy episodic drinking, defined as 1+ 
heavy drinking episode in the past 30 days on the Timeline Followback, and (c) DSM-5 and 
research diagnostic criteria for insomnia. Criteria for insomnia include difficulty (>30min) 
falling asleep, staying asleep, or waking up too early on 3+ nights per week for 3+ months that 
occurs despite adequate opportunity and circumstances for sleep and results in daytime 
impairment in mood, cognitive, social, or occupational activities. Daytime impairment will be 
characterized as scores ≥ 10 on the Insomnia Severity Index. 
 
Individuals will be excluded if they are unable to provide informed consent, began a new sleep 
medication in the past 6 weeks, report contraindications for CBT-I (mania or seizure disorder), 
have a severe psychiatric disorder that requires clinical attention (PTSD, major depression), or 
are currently receiving treatment for insomnia or alcohol use. 
 
6. Drugs/ Substances/ Devices 
N/A 
 
7. Study Statistics 
 
Outcome measures. Primary outcomes include insomnia severity, assessed using the Insomnia 
Severity Index (Morin, Belleville, Belanger, & Ivers, 2011); total wake time, assessed using 
sleep diaries and actigraphy; and sleep quality, assessed using daily sleep diaries (Carney et al., 
2012); drinking quantity and frequency per week, assessed using the Timeline Follow-Back 
(Sobell & Sobell, 1996); and alcohol-related consequences, assessed using the Brief Young 
Adult Consequences Questionnaire (Kahler, Hustad, Barnett, Strong, & Borsari, 2008). 
 
Secondary outcomes include delay discounting, assessed using the Monetary Choice 
Questionnaire (Kirby, Petry, & Bickel, 1999); negative affect, assessed using the Positive and 
Negative Affect Schedule (Watson, Clark, & Tellegen, 1988); emotion regulation, assessed using 

the Difficulties with Emotion Regulation Scale (Gratz & Roemer, 2004); and alcohol craving, 
assessed using the Penn Alcohol Craving Scale (Flannery, Volpicelli, & Pettinati, 1999).  
 
Power analysis. The expected effect size is large for insomnia outcomes (Taylor et al., 2014) and 
moderate for alcohol use outcomes (Fucito et al., 2017). We used G-Power to determine the 
sample size needed for an a priori repeated measures ANOVA, within-between interaction (α = 
.05, power = .95, groups = 2, repetitions = 3, correlation = .50). Based on these calculations, the 
sample required to detect a small effect (f = 0.1) is 260; a moderate effect (f = 0.25) is 44; and a 
large effect (f = 0.4) is 18. Assuming 5/month recruitment and 15% attrition, we will recruit 52 
participants over 10 months to obtain a final sample of 44 participants. This will provide us with 
an adequate sample size to detect moderate group by time interactions in insomnia- and alcohol-
related outcomes.  
 
Data analysis. Data will be screened for missing values, outliers, normality, and homogeneity of 
variance before analysis. Assuming there are no significant group differences on baseline 
measures of each outcome, repeated measures analysis of variance with time (baseline to 1 
month) as the within-subjects factor and randomized condition (CBT-I vs. sleep hygiene) as the 
between-subjects factor will be conducted. If there are significant differences between groups on 
baseline measures of an outcome, a one-way analysis of covariance, controlling for that variable 
at baseline, will be conducted.  
 
Early stopping rules. PI Miller will monitor adherence to the study protocol and adverse events 
on an ongoing basis and discuss these issues with the research team during weekly meetings. All 
serious and unexpected adverse events will be reported to the IRB within 24 hours of receipt of 
information. Other adverse or potentially adverse events will be monitored and reported at 
annual continuing reviews. After discussion with the IRB, we will discontinue the trial if there is 
(a) compelling evidence from this or another study of a serious adverse effect of CBT-I that has 
potential to override potential benefit, (b) compelling evidence from this or another study of a 
significant beneficial effect of CBT-I, such that continued denial to other groups would be 
unethical, or (c) low probability of addressing study aims within a feasible time frame.  
 
8. Risks 
We believe the risks associated with completing assessments and participating in the intervention 
are minimal. Potential risks include: temporary daytime fatigue (due to restriction of time in 
bed), subjective discomfort from answering questionnaires, coercion, and the possibility of a 
breach of confidentiality. Participants will not incur financial risk. There are no other known 
iatrogenic effects of CBT-I or completion of sleep diaries. However, if any emerge, they will be 
addressed immediately by research and/or clinical staff. 
 
The following safeguards will be implemented to protect participants from risks related to study 
participation:  
Temporary fatigue. Participants will be informed as part of the consent process that 
restricting their time in bed may increase daytime fatigue for the first few weeks of treatment 
(although this will be temporary, as time in bed will be expanded as sleep efficiency improves). 
Consistent with standard insomnia treatment procedures, time in bed will never be restricted to 
less than 5 hours in order to avoid impaired vigilance and significant daytime sleepiness. 

Participants will also be provided with recommendations on ways to increase alertness and 
counter daytime fatigue (e.g., staying active, engaging in social activities, strategic use of 
caffeine and water).  
Discomfort. All measures used in this study are well-validated clinical measures that have 
been used extensively with this and/or similar populations of patients. Participants will be 
informed of the types of questions that they will be asked to answer as part of the informed 
consent process, and they will have the opportunity to skip questionnaire items or discontinue 
participation in the study at any time without penalty. In addition, referrals will be provided to 
participants during the consent and throughout the study, in the event that participants report 
experiencing distress. 
Coercion. Participants will be provided with modest compensation for their participation 
in the study. Specifically, participants will be paid $20 for completion of the baseline assessment 
(60-90min), $5 for on-time completion of each of six weeks of daily diaries (~5min each), $25 
for the post-treatment assessment (45-60min), and $25 for the one-month follow-up (45-60min). 
We believe these compensation rates are commensurate with the time and effort involved in 
these tasks, and the amounts are consistent with compensation provided for other clinical 
insomnia studies. Participants are free to discontinue at any time and will receive compensation 
for any and all assessments that they complete.  
Confidentiality. Several steps will be taken to ensure that data remain confidential. Study 
data will be handled only by research staff and will be used strictly for research purposes. All 
research staff will be trained in responsible research conduct and the handling of private and 
confidential information. Identifying information will not be recorded on computerized or paper-
and-pencil assessments; rather, assessment instruments and related study data will be identified 
and tracked using a unique study identification number. The database containing identification 
numbers and contact information will be stored separately from study data and will be used to 
link baseline, post-treatment, and follow-up assessments. This database will be stored on a 
password-protected computer accessible only to research staff and will be destroyed immediately 
upon completion of the study. Identifying information (names and dates) will appear only on 
consent forms, payment receipts, and the contact information form. Participant addresses, which 
will be collected in order to allow research staff to follow up with participants who do not return 
the Philips Respironics Actigraphy device, will appear only on the contact information form. All 
paper forms containing identifying information will be kept in a locked filing cabinet in a locked 
room in the Department of Psychiatry, separate from any data. Only research staff will have 
access to these filing cabinets. Audiotaped treatment sessions, which will be used in fidelity 
coding, will not be labeled with identifying information and will be deleted permanently once 
fidelity coding is complete. Self-report assessment data collected using computer software will 
be stored electronically and identified by unique study number only. No personally identifying 
information will be included in the data. A password will be required to access data that are 
stored electronically, and only personnel involved with the project will have access to the 
electronic data. The computer-administered surveys provide an additional layer of confidentiality 
protection relative to paper and pencil surveys where staff would see a participant’s data as they 
were entering or storing it. 
Pending participant permission, participants will receive research appointment reminders 
via text or phone. Some text messages and phone calls may be made using Google Voice, which 
allows research staff to send texts and phone calls from their personal phones using a separate 
phone number. This separate phone number, which is provided free of charge, can subsequently 

be unlinked from one’s personal phone. We believe use of text messaging will improve our 
ability to contact and retain the young adults in our study, as they frequently decline to answer 
phone calls or respond to emails. This will allow research staff to contact and respond to 
participants while not in the office. We will take several steps to protect the privacy and 
confidentiality of participant information:  (1) Google Voice will be downloaded and used only 
on password-protected phones by research assistants (RAs) who have been trained in responsible 
conduct of research. (2) Participant phone numbers will not be saved on the device; rather, RAs 
will enter the phone number manually each time they need to contact a participant. (3) Text 
messages will be used only for scheduling purposes (e.g., "We have you scheduled for a research 
appointment tomorrow (date) at (time). To confirm text YES. To decline text NO"). To protect 
participant privacy and confidentiality, we will not include the name of the study in the body of 
the text message. If participants ask about details regarding the study via text, we will follow up 
with them by phone call and explain that we are unable to disclose study information via text. (4) 
All text messages and phone calls will be deleted permanently from RAs' phones every week so 
that participant phone numbers are no longer accessible from the RA's phone. RAs will be 
reminded to do this in weekly research meetings. 
 
Similarly, participants who have not returned a Phillips Respironics Actigraphy device 
and have not responded to electronic communication (i.e. calls, texts, emails) will be mailed a 
letter reminding them to return the device. To protect privacy and confidentiality, the letter will 
not include the name of the study or the university department. 
Participants will be informed verbally and in writing during the consent process that 
mandatory reporting laws will be followed. Subjects who indicate current danger to themselves 
or others during the study will be escorted to the emergency room or Urgent Care services, both 
of which are located in the same building as the Department of Psychiatry 
Given the sensitive nature of information being collected, all data will be protected by a 
Certificate of Confidentiality and identified using unique ID numbers assigned to participants 
specifically for this project. Names and identifying information required for follow-up reminders 
will always be kept separate from research data and will not be used as study data. Informed 
consent papers will be stored in a locked filing cabinet in a locked office that is accessible only 
to project staff. Computerized survey data will be stored electronically on a password-protected 
server. Digital audio recordings of treatment sessions, which will be used to determine treatment 
fidelity, will be stored on password-protected computers to which only project staff will have 
access. All research staff will be trained in procedures for maintaining data and participant 
confidentiality. 
Data safety and monitoring plan. PI Miller will monitor procedures to ensure that they 
conform to the approved protocol. Specifically, she will monitor (a) the progress of the research, 
including participant recruitment and retention and assessments of data quality; (b) adverse 
events and procedures for making determinations that there may be a change to the benefit-to-
risk ratio of research participation; and (c) procedures to protect participant privacy and 
confidentiality. She will monitor all serious, unexpected, and other adverse or potentially adverse 
events. Serious adverse events include those resulting in death, inpatient hospitalization, a threat 
to life, persistent or significant disability or incapacity, congenital anomalies/birth defects, or 
serious health risk. Unexpected adverse events are those that were unforeseen based on the 
anticipated potential risks outlined in the study protocol and informed consent. Other adverse or 

potentially adverse events include those that may be causally related to study participation and 
lead to participant distress or drop-out.  
 
PI Miller will monitor data quality and adverse events on an ongoing basis and discuss these 
issues with the research team during weekly meetings. All serious and unexpected adverse events 
will be reported to the IRB within 24 hours of receipt of information. Other adverse or 
potentially adverse events will be monitored and reported at annual continuing reviews. 
 
9. Benefits 
Participants in the CBT-I and Sleep Hygiene conditions may benefit from the sleep-related 
information provided. Participants may also appreciate the opportunity to engage in research that 
may help others benefit from treatment. Beyond these potential benefits to subjects, this research 
is expected to inform future research and clinical efforts to treat insomnia and reduce the 
consequences associated with alcohol use among young adults. As noted above, we believe the 
risks of this research to participants are minimal and the overall benefits of this research to 
subjects and society outweigh these risks. 
 
10. Payment and Remuneration 
To enhance follow-up rates, participants will receive $20 for completion of the baseline 
assessment ($10 at the baseline assessment appointment and $10 when they return the actiwatch 
one week later), $5 for completion of each of six weeks of daily diaries, $25 for the post-
treatment assessment ($10 at the post-treatment appointment and $15 when they return the 
actiwatch one week later), and $25 for the one-month follow-up ($10 at the post-treatment 
appointment and $15 when they return the actiwatch one week later). The total potential earnings 
would equal $100. Participants who choose not to complete an assessment will not receive 
payment for that assessment; however, they will be invited to participate in any subsequent 
assessments (e.g., if they decline the post-treatment assessment, they will still be invited to 
complete the one-month follow-up).  
 
11. Costs 
Participants will be expected to travel to the Department of Psychiatry for assessment and 
therapy appointments. It is unlikely that the expense of this travel will be a burden to 
participants, as the Department of Psychiatry is located in downtown Columbia and is easily 
accessible by foot, car, public transportation, and the University of Missouri shuttle system. 
However, participants will be expected to cover the cost of these expenses. Participants will not 
be charged for other study procedures or for insomnia treatment.  
 
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