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ScienceDirect Behavior Therapy 45 (2014) 376 – 389

www.elsevier.com/locate/bt

A Pilot Randomized Controlled Trial of the Effects of Cognitive-Behavioral Therapy for Insomnia on Sleep and Daytime Functioning in College Students Daniel J. Taylor Marian R. Zimmerman University of North Texas Christie E. Gardner Texas Tech University Jacob M. Williams The University of Texas Health Science Center at San Antonio Emily A. Grieser Wilford Hall Ambulatory Surgical Center Jolyn I. Tatum Wright-Patterson Medical Center Adam D. Bramoweth VA Pittsburgh Healthcare System Jade M. Francetich Camilo Ruggero University of North Texas, Department of Psychology

The purpose of this study was to pilot test if cognitive behavioral therapy for insomnia (CBT-I) is an effective intervention for insomnia and daytime functioning in college students. College students’ developmental stage and lifestyle are significantly different than the general adult population, yet there have been no studies of CBT-I in this age group. This work was supported by a small grant [G33817] from the University of North Texas. Address correspondence to Daniel J. Taylor, Ph.D., Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, Texas 76203; e-mail: [email protected]. 0005-7894/45/376-389/$1.00/0 © 2013 Association for Behavioral and Cognitive Therapies. Published by Elsevier Ltd. All rights reserved.

Thirty-four college students (ages 18–27; M = 19.71, SD = 2.10) were randomly assigned to and completed either six sessions of CBT-I or a 6-week wait list control (WLC). All participants completed 1-week sleep diaries and actigraphy, as well as sleep and daytime functioning questionnaires at baseline and posttreatment. The treatment group repeated all measures at 3-month follow-up. Students who received CBT-I showed greater baseline to posttreatment improvements in sleep efficiency, sleep onset latency, number of awakenings, time awake after sleep onset, sleep quality, insomnia severity, dysfunctional beliefs about sleep, general fatigue, and global sleep quality than the WLC group. These improvements were durable at 3-month follow-up. Ninety-four percent of participants in the CBT-I condition completed at least 4 sessions of

cognitive behavioral therapy for insomnia treatment. Significantly more participants in the CBT-I group than the WLC group responded (68.8% vs 7.7%, respectively) and remitted (68.8% vs 15.4%, respectively). CBT-I is an effective treatment for insomnia in college students. This study found that treatment responses were similar to results from studies in the general population. The treatment appeared to be well tolerated based on very low attrition rates.

Keywords: cognitive; behavioral; therapy; insomnia; college

INSOMNIA IS A UNIVERSAL PHENOMENON that has been experienced by most people (Edinger & Means, 2005). For an estimated 16% of the population, insomnia persists chronically (e.g., Lichstein, Durrence, Riedel, Taylor, & Bush, 2004), and has been associated with a myriad of daytime functioning problems, including anxiety, depression, medical problems, difficulties completing tasks, cognitive impairment, accidents, work absenteeism, and poor quality of life (Kuppermann et al., 1995; Roth & Roehrs, 1988; Taylor, Lichstein, Durrence, Riedel, & Bush, 2005; Taylor et al., 2007; Walsh, 2004). People with insomnia are also at a higher risk for developing depression, anxiety, substance abuse or dependence, suicide, impaired immune functioning, and cardiovascular disease (Taylor, Lichstein, & Durrence, 2003). Although complaints of insomnia are most frequently reported by older age groups (Lichstein et al., 2004; Ohayon, 2002), studies suggest 4% to 14% of young adults (ages 19–24) experience insomnia (Buboltz, Brown, & Soper, 2001; Ohayon & Roberts, 2001; Ohayon, Roberts, Zulley, Smirne, & Priest, 2000; Taylor et al., 2011), with the most rigorous definition indicating a prevalence of 9.5% (Taylor, Bramoweth, Grieser, Tatum, & Roane, 2013). College students with chronic insomnia report significantly worse sleep, fatigue, depression, anxiety, stress, and quality of life, as well as greater hypnotic or stimulant use for sleep problems, and increased health-care utilization, than normal sleepers (Bramoweth & Taylor, 2012; Taylor et al., 2013). Not surprisingly, over 60% of college students use stimulants to help them with daytime alertness, which may be causing some of the aforementioned sleep problems. Additionally, almost 7% report using sleep medication and over 11% report using alcohol as a sleep aid (Taylor & Bramoweth, 2010). This is a disturbing trend of substance use for a disorder that could affect these young adults for the rest of their lives without adequate treatment. Cognitive-behavioral therapy for insomnia (CBT-I) is an effective multicomponent nonpharmacological

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treatment that has been thoroughly studied in middle-aged and older adult populations (Morin et al., 2006; Morin, Culbert, & Schwartz, 1994; Murtagh & Greenwood, 1995; Nau, McCrae, Cook, & Lichstein, 2005). More research is needed to determine if typical CBT-I procedures are effective with college students, because these young adults differ from the general adult population in terms of their developmental stage, sleep schedules, and living environments, and may require adjustments to the typical CBT-I protocol (Breslau, Roth, Rosenthal, & Andreski, 1997; Crowley, Acebo, & Carskadon, 2007; Johns, 1992; Levine, Roehrs, Zorick, & Roth, 1988; Machado, Varella, & Andrade, 1998). In addition, most previous studies of CBT-I have primarily focused on sleep-related outcomes. Very few of them examined the daytime effects of improving insomnia in this population, and none have done so comprehensively. Recently a panel of 25 experts in the field of sleep research developed recommendations for comprehensive standard assessments to be used in insomnia research studies in order for investigators to have “common metrics for describing insomnia participants and research outcomes” (Buysse, Ancoli-Israel, Edinger, Lichstein, & Morin, 2006). To date, no single study has reported CBT-I outcomes on all of the “essential” measures recommended by this group. The objective of the present study was to test the efficacy of CBT-I in college students to improve sleep and daytime functioning outcomes, following recommended assessment guidelines (Buysse et al., 2006).

Methods participants A total of 171 individuals responded to study recruitment advertisements. The final sample contained 34 students aged 18 to 27 (M = 19.71; SD = 2.10), with 58.8% females, randomized into either the treatment (n = 17) or waitlist control (n = 17) group. The sample was 59% Caucasian, 21% Hispanic, 12% African American, 6% Asian/ Pacific Islander, and 3% multiracial, which closely approximated the makeup of the student body. Participants received $20.00 for completing the pretreatment phase, $20.00 for completing the treatment phase and posttreatment questionnaires, and $10.00 for completing follow-up questionnaires 3 months after treatment ended. Figure 1 summarizes participant flow through follow-up. procedures Participants were recruited from the general student population of the University of North Texas and all procedures and treatment occurred in the Insomnia Research Clinic on campus. Students were included

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taylor et al. 171 Calls from Potential Participants 35 – Unable to contact 136 Screening Phone Calls to Potential Participants 77 Excluded 25 – Not interested 7 – Not able to attend appointments 45 – Not Eligible: Not students (2), subclinical insomnia (13), taking psychotropic/sleep medications (17), significant psychiatric condition or other sleep disorder (13)

59 In-person Interview 34 Randomized

17 Allocated to CBT-I 16 – Completed Study 0 – Dropped out before treatment started 1 – Dropped out during treatment phase Reasons: Unable to keep study related appointments due to scheduling conflicts

25 Excluded 15 – Did not keep appointments 1 – Not interested 2 – Did not meet insomnia criteria 7 – Significant psychiatric condition or other sleep disorder

17 Allocated to WLC 13 – Completed Study 3 – Dropped out before WLC started Reasons: Did not return pretreatment questionnaires 1 – Dropped out during WLC period Reasons: Not interested in participating

7 Completed Three Month Follow-Up 9 – Lost to follow-up N/A

FIGURE 1 Participant flow chart following Consolidated Standards of Reporting Trials (CONSORT) Guidelines. CBT-I = Cognitive behavioral therapy of insomnia; WLC = Wait list control.

in the study if they were at least 18 years old, experienced self-reported sleep onset latency or time awake after sleep onset greater than 30 minutes at least 3 nights per week for at least 3 months, and experienced daytime consequences of insomnia, which corresponds to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-5; American Psychiatric Association, 2013). They were excluded if they were taking prescription medications to treat insomnia or another psychiatric condition, if they reported a diagnosis or symptoms suggestive of another sleep disorder (such as circadian-rhythm sleep disorder), or a significant psychiatric condition (such as bipolar disorder or post-traumatic stress disorder) that is associated with sleep disturbances and could interfere with treatment. Any student who volunteered for the study was first asked to complete a telephone screening interview. All participants who were not excluded during the phone interview were seen for an intake session during which they provided informed consent to participate in the

study and underwent structured clinical interviews by a trained doctoral student interviewer who was blind to treatment condition. Those who passed this level of screening were given a sleep diary and a packet with a demographic questionnaire, a medical health history questionnaire, and the pencil-andpaper measures to complete at home and were scheduled for an overnight sleep study. One week later, sleep diaries were reviewed to ensure participants were currently experiencing at least 30 minutes of sleep onset latency or wake time after sleep onset on at least 3 nights during the week and questionnaire packets were collected. Participants who passed all screening were then randomly assigned to either the CBT-I treatment condition or the waitlist control (WLC) condition. Randomization was conducted using a blocked randomization procedure with block sizes of four, generated by the first author (DJT) using a random number generator, in an effort to ensure an equal number of participants were randomly assigned to

cognitive behavioral therapy for insomnia each group (Friedman, Furberg, & DeMets, 1998). Randomized group assignments were placed in individual envelopes by a member of a different research lab and placed in a locked cabinet. Once a patient passed all inclusion and exclusion criteria and was enrolled in the study, the project coordinator drew the next envelope and revealed group assignment. Participants in the treatment condition received six sessions of CBT-I. Participants in the WLC group were offered an opportunity to receive treatment upon the completion of the study. After 6 weeks of treatment or WLC, all participants were given (either in person or via email) a sleep diary and packet of questionnaires to complete at home or online. Participants in the CBT-I group were also given the posttreatment interview. Three months following the end of treatment, participants in the CBT-I group were given a sleep diary and packet of questionnaires to complete at home or online. This study was conducted in compliance with the University of North Texas Internal Review Board.

cognitive behavioral therapy of insomnia (cbt-i) A meta-analysis of research studies using CBT-I reported treatment durations typically range from 2 weeks to 6 months with average treatment durations of 6.7 weeks (Morin et al., 1994). In order to cover the essential components and complete all treatment sessions within an academic semester, a 6-session individual treatment protocol was developed. This treatment protocol was based on two treatment manuals developed by leaders of this field, Morin and Espie (2003) and Perlis and colleagues (2005). The interventions included in the treatment protocol are those that have been shown to be efficacious in prior research and have been recommended by the American Academy of Sleep Medicine for the treatment of insomnia (Morgenthaler et al., 2006), including stimulus control, sleep restriction, sleep hygiene, relaxation training, and cognitive restructuring. Stimulus Control The stimulus control intervention was derived from the rationale that insomnia is due to a conditioned association between the bedroom and poor sleep (Bootzin, 1972; Bootzin, Epstein, & Wood, 1991). Participants were asked to limit the use of their bed to sleep or sexual activity, get out of bed if it takes longer than 20 minutes to fall asleep or if they awaken during the night and cannot return to sleep within 20 minutes. Sleep Restriction Sleep restriction involved reducing a participant’s time in bed to more accurately reflect the amount of

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time they spend sleeping on a typical night, in an effort to consolidate sleep, thus improving depth, continuity, and consistency (Spielman, Saskin, & Thorpy, 1987). Participants were asked to spend no more than their average total sleep time + 30 minutes in bed per night, based on the previous week’s diary. They were also asked to keep a consistent bedtime and wake time and limit naps to less than 60 minutes before 3:00 P.M. As the participants’ sleep improved, time in bed was increased 15 minutes per week until further increases no longer produced improvements. Sleep Hygiene Sleep hygiene is a psychoeducational intervention designed to address a variety of behaviors that may influence sleep quality and quantity (Perlis et al., 2005). Participants were asked to: (a) avoid exercise, heavy meals, excessive fluids, alcohol, and nicotine within 2 to 3 hours of bedtime, (b) create a sleep environment that is cool, dark, quiet, and comfortable, (c) avoid going to bed worried or angry by writing down concerns and closing the book on them for the night, (d) avoid trying to sleep because the act of trying is incompatible with sleeping (Hauri, 1991; Morin & Espie, 2003). Relaxation Training Relaxation training is the most frequently employed treatment for insomnia and has displayed high effectiveness (Morin et al., 2006). Relaxation training counteracts physiological and mental arousal often reported by people with insomnia, thereby improving nighttime sleep. Participants were assisted in developing a pre-bedtime routine to help them wind down at the end of the day and prepare for sleep, and then taught a relaxation exercise that combined deep breathing, progressive muscle relaxation, and autogenic training. Participants were given an audio CD of the relaxation exercise recorded by their treating therapist, and asked to practice twice a day. Cognitive Restructuring Individuals’ beliefs, attitudes, and interpretations about their sleep problems may contribute to chronic insomnia (Morin, Stone, Trinkle, Mercer, & Remsberg, 1993). Cognitive restructuring elicited the participants’ dysfunctional beliefs and attitudes about sleep, systematically challenged these thoughts, and developed more adaptive thoughts.

assessment of treatment fidelity Therapist and participant compliance were assessed and quantified to ensure adequate therapist adherence, participant comprehension and adherence to intervention protocols.

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Therapist Adherence Therapy was conducted by three doctoral-level graduate students who were thoroughly trained in CBT-I and supervised by a licensed psychologist (DJT) with expertise in CBT-I and certified in behavioral sleep medicine. Therapists were given checklists to follow during sessions to ensure all components of the interventions were administered appropriately. All sessions were digitally recorded and 25% were randomly selected and rated for adherence to the treatment manual and quality of the therapy delivered by the other two therapists. Having other therapists rate sessions also provided booster training sessions for the rating therapists. Audio recordings of 23 treatment sessions (i.e., 25.6% of the total treatment sessions) were randomly selected to be evaluated by the other two graduate student therapists. The evaluators rated each component specified in the treatment manual in each session on a 5-point Likert -type scale (0 = poor/absent, 2 = present/acceptable, 4 = excellent). Participant Comprehension Participants were given the rationale and written handouts for each treatment intervention. Therapists stopped after each new concept was introduced to ask the participant if he or she understood the concept and answer any questions. Procedural modifications, such as a slower pace or repeated focusing on troublesome areas, were adopted when problems arose. Participant Adherence Participants were asked to record sleep times on a sleep diary throughout treatment. Adherence was calculated by comparing prescribed time in bed to the actual time in bed reported on the diaries. Participants were given handouts each week with written instructions on procedures, tips, and rationale to help promote adherence. They were also given a relaxation CD that contained a recording of the exercise presented during treatment to use at home to ensure adequate pacing. In addition, participants were asked to keep a weekly self-report log recording if they were adherent to each of the instructions (e.g., “Did you avoid bedroom activities besides sleep and sex?” “Did you get up at your new scheduled wake time?”) for each day each week. These logs were additive each week, in that as new skills were taught (e.g., sleep hygiene, relaxation), they were also added to the logs. At the beginning of each session, the previous week’s sleep diaries and logs were collected and reviewed with the participant.

measures Duke Structured Interview for Sleep Disorders The Duke Structured Interview for Sleep Disorders (Edinger et al., 2006) is a semistructured interview

and system of self-report checklists designed to obtain a medical history, mental health history, and sleep history in order to indicate whether a participant meets criteria for a sleep disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (4 th edition; DSM-IV-TR; American Psychiatric Association, 2000) and the International Classification of Sleep Disorders, Second Edition (ICSD-2). It also provides information about the relative contributions of psychological, behavioral, environmental, and medical factors to the sleep problem. The Duke Structured Interview for Sleep Disorders has been found to have acceptable discriminant validity and reliability with kappa values ranging from .71 to .86 across DSM-IV-TR and ICSD-2 categories (Carney, Ulmer, Edinger, Krystal, & Knauss, 2009). Structured Clinical Interview for DSM-IV Axis I Disorders – Clinician Version (SCID) The SCID (First, Spitzer, Gibbon, & Williams, 1996) is a semistructured interview designed to assess for the presence of a major mental disorder such as a psychotic disorder, mood disorder, anxiety disorder, or substance abuse disorder. It incorporates DSM-IV diagnostic criteria in a structured, standardized interview that yields formal psychiatric diagnoses. The SCID has an adequate to high level of interrater reliability with kappa scores ranging from .57 for anxiety disorders to 1.0 for substance use disorders (Skodol et al., 2005). The SCID also shows good concurrent validity, with kappa scores for comparisons between SCID and diagnostic interviews ranging from .57 to .72 for different diagnoses, sensitivity ranging from .53 to .84, and specificity ranging from .91 to .97 (Basco et al., 2000). Polysomnography (PSG) PSG is an overnight sleep study used to document the presence or absence of occult sleep disorders at baseline only. PSGs were recorded unattended, in participants’ homes, and performed according to guidelines and procedures developed by the Sleep Heart Health Study (Redline et al., 1998). PSGs were performed with digital Compumedics Siesta Series portable sleep systems, and included recording of electroencephalogram from C3, C4, O1, and O2, left and right electro-oculogram; chin and leg electromyogram; electrocardiogram [modified lead II], thermistor and nasal pressure, and oximetry (Compumedics USA, Inc., Fridley, Minnesota). Sleep Diaries Seven pencil-and-paper daily sleep diaries were used to obtain prospective sleep data at baseline, during treatment, at posttreatment, and at follow-up. The variables measured by sleep diaries were: sleep onset

cognitive behavioral therapy for insomnia latency, time awake after sleep onset, time spent in bed after final awakening in the morning, number of awakenings during the night, total sleep time, time in bed, sleep efficiency, and sleep quality. Participants were asked to complete diaries in the morning to obtain an estimate of the amount of sleep they had the night before, to rate the quality of their sleep, and rate how alert they felt upon awakening. Before going to bed at night, they were asked to rate how alert they felt during the day and record the duration of any naps they took. Sleep diaries are significantly correlated with PSG on wake time after sleep onset, total sleep time, and sleep efficiency, r(57) = .46–.59 (Lichstein et al., 2006), and are better than single time-point retrospective estimates of sleep (Coursey, Frankel, Gaarder, & Mott, 1980). For baseline sleep diary measures, participants were asked to keep sleep diaries for 1 week prior to being randomly assigned to one of the groups. Either the week immediately prior to treatment or 5 to 7 days within the data collection period without missing data or unusual circumstances (e.g., illness) were used for these baseline analyses. Actigraphy Actigraphy, a measure of sleep and activity patterns, was used concurrently with sleep diaries to obtain prospective sleep data at baseline, during treatment, and at posttreatment. Actigraphy was recorded with AW64 Actiwatches (Mini Mitter, Bend, OR), which are compact, wrist-worn, battery-operated activity monitors that look similar to a small wristwatch with an event marker button participants can press to indicate in and out of bed times (Respironics, 2005). In patients with insomnia, there are high correlations for total sleep time measures between actigraphy and PSG, r(36) = .81, and between actigraphy and sleep diaries, r(36) = .53 (Chambers, 1994). Correlations between actigraphy and PSG in the current study (e.g., sleep onset latency r[24] = .42, total sleep time r[23] = .81, sleep efficiency r[23] = .42) were equivalent or exceeded those found by other researchers (Chambers, 1994; Lichstein et al., 2006). Some participants did not wear the actigraph for the entire night, resulting in missing data for 6.24% of the nights across baseline and posttreatment, which is slightly better than reported by others (Tworoger, Davis, Vitiello, Lentz, & McTiernan, 2005). When patients failed to use the event markers to indicate in and out of bed times, the bedtime and wake times extracted from the sleep diaries were used when they appeared to match the activity. Questionnaires The following self-report questionnaires were used as an additional assessment of sleep and daytime functioning. The Insomnia Severity Index (Bastien,

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Vallieres, & Morin, 2001), Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989), 16-item Dysfunctional Beliefs and Attitudes about Sleep (Morin, Vallieres, & Ivers, 2007), Epworth Sleepiness Scale (Johns, 1991), Multidimensional Fatigue Inventory (Smets, Garssen, Bonke, & De Haes, 1995), Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Endicott, Nee, Harrison, & Blumenthal, 1993), Quick Inventory of Depressive Symptomatology (Rush et al., 2003), State-Trait Anxiety Inventory, Trait Scale, Form Y (Spielberger, 1983), Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983), Alcohol Use Disorders Identification Test (Saunders et al., 1993), and Marijuana Problem Scale (Stephens, Roffman, & Curtin, 2000). This group of questionnaires, along with the measure above, corresponds to the recommendations made by a 2005 panel of 25 experts in the field of sleep research for standard assessments to be used in insomnia research studies in order for investigators to have “common metrics for describing insomnia participants and research outcomes” (Buysse et al., 2006). All measures have extensive and adequate reliability and validity data. Posttreatment Survey At the end of therapy, all participants in the CBT-I group were administered a posttreatment survey in order to assess the feasibility and acceptability of the therapy, as recommended for treatment development studies (Ong, Wickwire, Southam-Gerow, Schumacher, & Orsillo, 2008). The survey consisted of eight open-ended questions and two ratings (1 to 10 scale) which were designed to give participants an opportunity to give feedback about the treatment received. Open-ended questions elicited participants’ opinions about the treatment in general, most and least beneficial portions of treatment, most and least challenging aspects of treatment, and areas of treatment they would change. Participants were also asked if they felt they had insomnia and what recommendations they would give to a friend who has trouble sleeping. Additionally, they were asked to rate their confidence and motivation to follow the recommendations of treatment.

statistical analysis The primary hypothesis was that CBT-I would result in greater sleep efficiency improvement from pretreatment to posttreatment than the WLC. Thus, the primary endpoint was sleep efficiency (i.e., total sleep time/time in bed × 100) at posttreatment gleaned from sleep diaries and then actigraphy. The statistical design for the primary analysis was a linear mixed model regression examining group (CBT-I vs. WLC) by time-point (Pretreatment to Posttreatment) main

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effects and interactions on the primary outcome of sleep efficiency. Secondary sleep endpoints were the components of sleep efficiency (i.e., sleep onset latency, number of awakenings, wake time after sleep onset, time spent in bed after final awakening in the morning, and total sleep time) gleaned from sleep diaries and then actigraphy. Other secondary endpoints were sleep and daytime functioning questionnaires. Chi-Square Tests of Independence were also performed in an effort to determine if CBT-I resulted in more response (i.e., 50% reduction; Frank et al., 1991) or remission (i.e., Insomnia Severity Index score b 8; Dolan, Taylor, Bramoweth, & Rosenthal, 2010). Repeated measures ANOVAs and MANOVAs were conducted for all of the dependent variables used in the pretreatment to posttreatment comparisons to evaluate if the treatment group maintained gains from posttreatment to follow-up. Experiment-wise corrections were considered, but since this was largely a pilot study to test the efficacy of CBT-I on improving daytime functioning and because multiple constructs were being measured, it was felt that it would be acceptable to leave the significance level at the more liberal two-tailed alpha = 0.05. However, effect sizes were reported to put statistically significant results in context of clinical significance. All self-report data were entered and double-checked by lab research assistants and all analyses were performed by the first author (DJT). None were blind to condition.

power analysis A power analysis was conducted in order to determine the appropriate sample size for this study using G*Power 3.1 (Faul, Erdfelder, Lang, & Buchner, 2007). A previous meta-analysis of psychological treatments of insomnia suggested combined psychological interventions, such as the treatment used in this study, yield an average effect size at the end of treatment of Cohen’s d = 1.0 (Murtagh & Greenwood, 1995). A more recent study of telephone-delivered CBT-I versus an information pamphlet control found an effect size of d = 1.9 for sleep efficiency using linear mixed model regression (Arnedt et al., 2013). Because this was a pilot study with a large number of dependent variables, a more conservative anticipated effect size was set at d = 0.5, the error probability (alpha level) was set at .05, and the power level was set at .80. The result of this analysis indicated a total sample size of 34 was needed for this study.

Results baseline Analyses of the baseline measures indicated there were no significant differences between the CBT-I

Table 1

Demographic and Clinical Information on the Sample Characteristic

Age Gender Female Male Race/Ethnicity African American Asian/Pacific Islander Hispanic Caucasian Multi-ethnic

WLC

CBT-I

(n = 17)

(n = 17)

p

19.94 (2.49)

19.47 (1.66)

.521 .081

10 7

4 13

2 2 2 11 0

2 0 5 9 1

.344

and WLC groups on demographics prior to treatment, although there was a trend for a greater percentage of males to be in the treatment group (Table 1). Previous studies have shown there are no gender differences in response to CBT-I (Bliwise, Friedman, Nekich, & Yesavage, 1995; Currie, Wilson, & Curran, 2002; Espie, Inglis, & Harvey, 2001), which was verified by exploratory analyses in the current study (all ps N .10).

attrition Of the 17 participants in the CBT-I group, 15 completed all 6 treatment sessions, and 1 completed 4 treatment sessions, which was considered a minimally acceptable dose, and returned 6 weeks after the start of treatment to complete the posttreatment questionnaires, which were analyzed with the treatment completers. Of the 17 participants in the WLC group, 3 dropped out after randomization. Comparisons between participants who dropped out and who completed the study indicated no significant differences on demographic variables, other sleep diary variables, sleep-related questionnaires, or daytime functioning measures. treatment fidelity The overall mean rating for all of the evaluated sessions was 2.85 (SD = 0.56). The raters observed an overall mean of 90.49% (SD = 14.78) of the required components to be present. Patient adherence was also quite good, with a mean difference between prescribed bedtime and actual bedtime of 7.65 minutes and between prescribed wake time and actual wake time of 20.61 minutes. Combined, these are similar to values found by Riedel and Lichstein (2001). pretreatment to posttreatment comparisons The primary analysis showed a significant Group (CBT-I vs. WLC) × Time (pre- vs. posttreatment)

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cognitive behavioral therapy for insomnia interaction (d = 1.06), where the CBT-I group showed significantly better improvement in sleep efficiency from pre- to posttreatment assessment (Table 2 and Figure 1). Analyses were then conducted on the sleep continuity variables that make up sleep efficiency. The results indicated significant Group × Time interactions with large effect sizes (d = 0.91–1.23) for all variables but total sleep time and time spent in bed after final awakening in the morning, with the CBT-I group doing significantly better in all cases (Table 2). The same results can

be seen for sleep quality ratings. As can be seen in Table 2, none of the analyses of actigraphy data were significant, and all effect sizes were small, with the exception of a moderate effect for sleep onset latency. Analyses of sleep questionnaires (Table 2) indicated a significant Group x Time interaction with large effect sizes (d = 1.03-1.22) for all measures but the Epworth Sleepiness Scale (d = 0.16). In addition, as measured by the Insomnia Severity Index, significantly more participants in the CBT-I group than the WLC group responded

Table 2

Pretreatment to Posttreatment and Follow-up (CBT-I only) Univariate Analyses of Sleep Diary Measures Between Groups Pretreatment

Posttreatment

Follow-Up

Group × Time (Pre- vs Post-)

CBT-I

WLC

CBT-I

WLC

CBT-I

Mean (SD)

Mean (SD)

Mean (SD)

Mean (SD)

Mean (SD)

F

p

95.48 452.20 12.18 0.66 5.18 4.24 7.55

(3.43) (57.35) (7.45) (0.92) (7.16) (6.25) (1.17)

84.40 (13.63) 452.00 (59.50) 49.44 (45.42) 0.81 (0.94) 11.05 (22.57) 12.50 (11.91) 5.81 (1.10)

95.95 (4.12) 485.53 (67.76) 12.41 (8.69) 0.51 (0.74) 4.55 (8.58) 4.59 (11.84) 7.94 (1.40)

7.97 0.32 5.58 7.98 10.50 2.26 7.32

.009 .574 .026 .009 .003 .144 .012

1.06 0.22 0.91 1.09 1.23 0.56 1.02

85.70 421.62 15.02 34.66 40.60 14.68

(3.61) (67.75) (8.02) (10.02) (10.77) (8.09)

83.47 (6.61) 440.16 (56.09) 24.65 (23.19) 37.97 (9.78) 39.80 (20.09) 18.47 (12.55)

N/A N/A N/A N/A N/A N/A

0.02 1.34 0.89 0.67 b 0.01 0.21

.902 .275 .365 .422 .989 .652

0.14 0.30 0.45 0.21 0.20 0.19

5.56 3.31 2.16 5.94

(5.21) (2.47) (1.28) (2.84)

11.38 (4.72) 7.62 (2.57) 4.59 (0.95) 8.08 (3.38)

10.27 7.27 11.43 0.20

.003 .012 .002 .660

1.20 1.01 1.27 0.17

9.81 8.25 9.88 8.19 8.56 75.33 35.56 4.19 12.75 2.56 0.44

(3.23) (3.15) (4.10) (3.17) (3.10) (12.68) (11.70) (3.83) (9.29) (3.33) (1.31)

12.77 (2.68) 9.46 (3.76) 11.38 (3.31) 9.92 (3.68) 8.31 (2.36) 65.80 (13.69) 40.42 (7.65) 6.54 (3.10) 15.92 (4.75) 3.00 (2.55) 0.92 (3.33)

8.47 1.30 0.74 3.97 0.65 3.17 0.10 2.57 b 0.01 0.03 1.75

.007 .264 .398 .056 .427 .086 .752 .121 .998 .862 .199

1.10 0.44 0.33 0.75 0.31 0.67 0.12 0.61 b 0.01 0.07 0.54

Sleep diary SE 82.33 (8.91) 84.30 (6.78) TST 429.39 (60.52) 440.97 (67.92) SOL 38.27 (27.90) 46.03 (22.38) NWAK 1.81 (1.09) 1.19 (0.98) WASO 27.79 (21.22) 12.70 (12.33) TWAK 23.48 (26.61) 20.10 (17.05) SQ 5.62 (1.26) 5.21 (1.34) Actigraphy SE 84.97 (3.87) 83.55 (6.70) TST 425.28 (45.65) 419.54 (49.25) SOL 21.22 (17.71) 24.49 (18.20) NWAK 34.43 (10.26) 35.76 (10.46) WASO 38.12 (10.97) 38.63 (17.92) TWAK 16.68 (8.42) 17.78 (9.51) Sleep Questionnaires ISI 15.24 (5.23) 15.29 (5.08) PSQI 9.59 (3.34) 9.86 (3.61) DBAS 5.02 (1.90) 5.43 (1.66) ESS 8.29 (3.06) 9.79 (4.21) Daytime Functioning Questionnaires MFI – GF 14.18 (3.45) 14.29 (2.30) MFI – PF 10.88 (3.50) 10.25 (4.39) MFI – MF 12.18 (4.13) 12.57 (2.24) MFI – RA 9.57 (3.99) 10.29 (2.73) MFI – RM 9.57 (2.24) 10.94 (3.42) Q-LES-QSF 59.80 (14.72) 59.69 (13.92) STAI 41.38 (12.67) 44.36 (9.07) QIDS 7.97 (4.09) 8.07 (3.60) PSS 16.13 (7.88) 18.86 (5.17) AUDIT 2.71 (2.95) 2.79 (2.08) MPS 1.24 (2.56) .29 (1.07)

2.43 3.14 1.04 3.00

(2.76) (1.21) (0.92) (2.08)

7.86 (1.77) 8.57 (4.24) 7.86 (3.02) 8.29 (3.40) 7.43 (3.95) 77.04 (21.41) 32.00 (11.45) 3.71 (3.25) 11.57 (8.92) 0.43 (0.79) 0.00 (0.00)

Cohen’s d

Note. CBT-I = Cognitive-behavioral therapy for insomnia (treatment group); WLC = Wait list control (control group); SE = sleep efficiency; TST = total sleep time; TIB = time in bed; SOL = sleep onset latency; NWAK = number of awakening during the night; WASO = time awake after sleep onset; TWAK = terminal wakefulness; SQ = sleep quality; ISI = Insomnia Severity Index; PSQI = Pittsburgh Sleep Quality Index; DBAS = Dysfunctional Beliefs and Attitudes about Sleep; ESS = Epworth Sleepiness Scale; MFI – GF = Multidimensional Fatigue Inventory – General Fatigue; MFI – PF = Multidimensional Fatigue Inventory – Physical Fatigue; MFI – MF = Multidimensional Fatigue Inventory – Mental Fatigue; MFI – RA = Multidimensional Fatigue Inventory – Reduced Activity; MFI – RM = Multidimensional Fatigue Inventory – Reduced Motivation; Q-LES-QSF = Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; STAI = State-Trait Anxiety Inventory, Trait Scale, Form Y; QIDS = Quick Inventory of Depressive Symptomatology; PSS = Perceived Stress Scale; AUDIT = Alcohol Use Disorders Identification Test; MPS = Marijuana Problem Scale.

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(68.8% vs 7.7%, respectively) and remitted (68.8% vs 15.4%, respectively). Finally, analyses of the daytime functioning questionnaires (Table 2) indicated a significant Group × Time interaction, with a large effect size for only Multidimensional Fatigue Inventory–General Fatigue (d = 1.10), with the CBT-I group doing significantly better. It is interesting to note that the analyses showed medium effect sizes for the Multidimensional Fatigue Inventory–Reduced Activity (d = 0.75), Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form (d = 0.67), Quick Inventory of Depressive Symptomatology (d = .61), and Marijuana Problem Scale (d = 0.54), but the study did not have power to find statistical significance at this level.

posttreatment to follow-up comparisons Results indicated there were no significant reductions from posttreatment to follow-up on any of the dependent variables, indicating durability of changes. There were, however, significant improvements on Dysfunctional Beliefs and Attitudes about Sleep, Epworth Sleepiness Scale, and Multidimensional Fatigue Inventory–General Fatigue (all ps b .05), indicating that there may be an incubation effect on these variables after CBT-I that may be missed in simple pre- to posttreatment analyses. It is of note that the treatment group added an additional 33 minutes to their TST from posttreatment to follow-up, but this was not statistically significant given the large amount of variability (i.e., SD = 67.76). posttreatment survey Posttreatment surveys were completed by 15 out of 16 of the CBT-I participants. Half of the participants (50.0%) reported they no longer had insomnia (e.g., remission), 35.7% reported they continued to have insomnia and 14.3% reported they were not sure. All of the participants reported positive responses to treatment, and many stated they enjoyed it or found it beneficial. Most commonly, participants reported the techniques they learned were helpful and their sleep problems were reduced or eliminated. Relaxation and sleep restriction were considered the most beneficial techniques. While nearly half of the participants found all parts of treatment beneficial, 13% considered relaxation and completing sleep diaries, progress logs, and other study-related paperwork the least beneficial. However, 45% would recommend having a consistent sleep schedule to a friend with insomnia. On a 10-point Likert scale, with a rating of 1 as least and 10 as most, the mean level of confidence in accomplishing the recommendations of treatment

was 8.27 (SD = 1.10). On the same 10-point Likert scale, the mean level of motivation to follow the recommendations of treatment was 7.53 (SD = 2.00).

Discussion This pilot study was the first randomized clinical trial to test the efficacy of multicomponent CBT-I on improving both sleep as well as a relatively comprehensive assessment of daytime function, as recommended by a recent expert panel (Buysse et al., 2006). As expected, students who received CBT-I reported a 16% improvement in sleep efficiency, 68% improvement in sleep onset latency, 81% improvement in wake time after sleep onset, 64% improvement in number of awakenings, and 34% improvement in sleep quality. They also reported a reduction in insomnia intensity and dysfunctional beliefs about sleep. Finally, significantly more participants in the CBT-I group than the WLC group responded (68.8% vs 7.7%, respectively) and remitted (68.8% vs 15.4%, respectively). Surprisingly, other than improvements in general fatigue, few improvements were seen in areas of daytime functioning (e.g., depression, anxiety, stress, quality of life). The improvements seen on the sleep-related variables, including remission, were consistent with the results of other CBT-I treatment studies conducted with the general and older adult populations (Dolan et al., 2010; Morin et al., 2004; Morin et al., 2006; Morin et al., 1994), and were slightly larger than gains reported by Smith and colleagues (2002). The results of this study were also consistent with the previous single and combined modality treatment studies with college students in that the participants showed improvements in sleep onset latency, number of awakenings, wake time after sleep onset, and sleep quality (Gellis, Arigo, & Elliott, 2013; Means, Lichstein, Epperson, & Johnson, 2000). The students in the current study showed improvements in sleep efficiency, dysfunctional beliefs about sleep, and fatigue, which were not found in previous college student studies that assessed these outcomes. There were no significant differences in time spent in bed after final awakening in the morning and total sleep time in this study. The time spent in bed after final awakening in the morning finding was likely due to a floor effect since neither group had clinically significant (N 30 minutes) levels of wake time in bed in the morning. The null finding with regards to total sleep time is common for cognitive and behavioral insomnia treatment studies and our effect sizes were similar, although slightly smaller, than those found in meta-analyses (Morin et al., 1994; Murtagh & Greenwood, 1995; Riemann & Perlis, 2009). The

cognitive behavioral therapy for insomnia reasons for this lack of movement in total sleep time are unknown, but are likely multi-fold. For one, typical cognitive and behavioral treatments of insomnia focus on decreasing time awake in bed rather than increasing total sleep time. In addition, CBT-I tends to be short-term (e.g., 4 to 8 sessions) and it may take more time than that to see significant gains in total sleep time, as demonstrated in the current study as well as other studies with long-term follow-up (Morin et al., 1994; Murtagh & Greenwood, 1995). There were no significant group differences in ratings of daytime sleepiness, other dimensions of fatigue or daytime functioning (e.g., depression, anxiety, stress, quality of life) when compared to the WLC group. The daytime sleepiness results were not surprising, as multiple studies have now shown that people with insomnia do not report more excessive daytime sleepiness than people without insomnia (Riedel & Lichstein, 2000); therefore, a floor effect may exist when trying to improve this measure of sleep (Dolan et al., 2010). Previous studies have also shown mixed results on the effect of CBT-I on daytime functioning, with some showing improvements in anxiety, depression, fatigue, and quality of life (Belleville, Guay, Guay, & Morin, 2007; Dirksen & Epstein, 2008; Espie, Inglis, Tessier, & Harvey, 2001; Quesnel, Savard, Simard, Ivers, & Morin, 2003) while others have found no differences (Edinger, Wohlgemuth, Radtke, Marsh, & Quillian, 2001; Jacobs, Pace-Schott, Stickgold, & Otto, 2004; Rybarczyk et al., 2005). One possible explanation for the lack of change in daytime functioning in this study is that both groups were relatively healthy (i.e., neither had clinically significant elevations on the daytime functioning measures), again creating a floor effect. Qualitatively, the CBT-I group responded positively to the therapy and described the treatment as enjoyable and beneficial. Half of the CBT-I group considered themselves to no longer have insomnia by the end of the treatment phase. The CBT-I group considered the relaxation strategies to be the most beneficial aspect of treatment and wearing the Actiwatch to be the easiest part. Although they considered following the prescribed sleep schedule the most challenging part of treatment, they also said they would recommend having a consistent sleep schedule to a friend with insomnia. These results are similar to those found by Ong, Shapiro, and Manber (2008). Administering CBT-I in college students presents multiple challenges. For one, the number of sessions had to be kept to a minimum (i.e., 6 sessions) in order to ensure the treatment could be completed in one semester (in case of dropout between semesters), while still maintaining the core components of

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CBT-I (stimulus control, sleep restriction, relaxation, and cognitive therapy). Other modifications that were necessary during the treatment included attempting to implement stimulus control and sleep restriction in shared dorm spaces (e.g., using headphones, ambient sounds, turning off electronics, and avoiding social media), acceptance that college student sleep schedules look very different from the general population (e.g., 0030–0930 rather than 2200–0600), greater emphasis on limiting alcohol (and other substances), irregular sleep schedules on the weekends, and a focus on scheduling things to do during "free time" in the morning (e.g., gym, grocery shopping, walk dog). In general, few modifications of the actual treatment materials and content were necessary in this population, which is a testament to the accuracy of the cognitive and behavioral models of insomnia on which the CBT-I interventions are based. The primary limitation in the current study was the lack of an active comparator. This study was funded by a small internal grant and there was not enough money to pay for the therapist time and participant time of a therapy placebo group. To date, no study has compared the effect of a WLC versus credible attention control in the insomnia literature. Murtagh & Greenwood (1995) performed one of the seminal meta-analyses of psychological treatments for insomnia and found placebo effects of d = .10–.46, depending on the outcome measured, when using primarily quasi-desensitization therapy as the placebo control. WLC adjusts very little for placebo effect. Therefore, results presented here should be interpreted with caution until they can be replicated in future studies which include a credible attention/ placebo control. Another weakness of the study was that the findings gathered using Actiwatch were not significant. These results were not surprising and are in agreement with those found in other randomized controlled trials exploring the efficacy of CBT-I on actigraphy assessed sleep (Epstein, Sidani, Bootzin, & Belyea, 2012; Espie et al., 2007; Rybarczyk, Lopez, Benson, Alsten, & Stepanski, 2002). Given the agreement with previous results, that sleep diaries are current standard of practice in these types of therapies, and the complaint is the hallmark of insomnia, the results presented here appear to show valid improvements in sleep after CBT-I. Additionally, the study had a small sample size that was relatively higher functioning with no comorbidities. All of these limit the generalizability of the study to the more common comorbid populations, requiring replication in these samples. That said, increasing research is showing that CBT-I has similar, albeit smaller, effects in many

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comorbid populations as well (Sánchez-Ortuño & Edinger, 2012). Another limitation was that we did not measure social functioning. As mentioned, we followed the recommendations of an expert panel, which did not actually include any specific measures of social function. Future studies should consider including measures specifically targeting social (Tyrer et al., 2005), marital (Spanier, 1976), and job (Jansson-Fröjmark, 2013; Yousef, 2000) functioning. Finally, our measures of adherence to the treatment (i.e., sleep diaries and progress logs) were all self-report. Therefore, it is impossible to know if the participants were truly following the treatment recommendations. Future studies should attempt to use more objective means (e.g., actigraphy) of verifying compliance with the interventions. It appears the response to multicomponent CBT-I is robust and college students benefit in similar ways as the general population. Future dismantling studies should examine whether there are differences in responses to multicomponent CBT-I versus the individual components or combinations of the components, to determine the minimally sufficient dose of cognitive and behavioral therapies necessary to produce meaningful change. In addition, dissemination studies could help determine how best to deliver these treatments within the college population. Unfortunately, no significant differences were seen between groups on most measures of daytime functioning. This is likely because these measures were not as highly elevated as might be seen in more severe clinical samples. Hopefully, future studies will continue to include these daytime as well as psychosocial functioning measures so we can better determine what the secondary gains of CBT-I are for people with insomnia. Conflict of Interest Statement The authors report no conflict of interest that could inappropriately influence this work.

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