A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Phase: NA
Conditions: Insomnia, Sleep Disturbance
Sponsor: University of Calgary

 
Updated: 2017/09/28 
 
  
Research Protocol 
 
 Official Title | A pilot randomized controlled trial of cognitive behavioural 
therapy for insomnia in pregnancy 
 
Brief Title | Sleeping for Two: RCT of CBT-Insomnia in Pregnancy 
 
Unique Protocol ID / Ethics Approval Certification: REB15-2137 
  
Lianne Tomfohr-Madsen, University of Calgary 
 Norah Vincent, University of Manitoba 
Joshua Madsen, University of Calgary 
Tyler Williamson, University of Calgary 
Amy Metcalfe, University of Calgary 
Tavis Campbell, University of Calgary 
 
 
Study Official / Principal Investigator: 
Lianne Tomfohr-Madsen, PhD 
Department of Psychology 
University of Calgary 
2500 University Drive NW 
Calgary AB, T2N 1N4 
 

Sleeping for Two Study Research Protocol 2  
  
Updated: 2017/09/28 
Sleeping for Two: A Pilot Randomized Controlled Trial of Cognitive Behavioural 
Therapy for Insomnia in Women during Pregnancy   
  
TABLE OF CONTENTS  
  
BACKGROUND AND RATIONALE ...................................................................................................... 3 
Objectives ..................................................................................................................................... 4 
METHODS......................................................................................................................................... 5 
Trial Design ................................................................................................................................... 5 
Inclusion and Exclusion Criteria ................................................................................................... 5 
Procedures ................................................................................................................................... 6 
Equipment .................................................................................................................................... 7 
Outcome Measures ...................................................................................................................... 8 
Primary Outcome Measures .................................................................................................... 8 
Secondary Outcome Measures ................................................................................................ 8 
Additional Measures and Questionnaires ................................................................................ 8 
ANALYSIS PLAN ................................................................................................................................ 9 
Sample Size Power Calculation .................................................................................................... 9 
Primary Aims ................................................................................................................................ 9 
Secondary Aims .......................................................................................................................... 10 
RESEARCH MANAGEMENT ............................................................................................................ 10 
RESEARCH ENVIRONMENT ............................................................................................................ 10 
REFERENCES ................................................................................................................................... 11 
TABLES AND FIGURES .................................................................................................................... 16 
 
  
  

Sleeping for Two Study Research Protocol 3  
  
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BACKGROUND AND RATIONALE  
  
Prevalence of sleep disturbances in pregnancy. Insomnia and poor sleep quality in pregnancy 
are common. During pregnancy, women experience a series of physiologic and emotional 
changes, ranging from alterations of hormonal secretions to fear of childbirth and parenthood. 
These changes can cause a series of somatic symptoms including sleep disturbances. In a study 
conducted with 486 pregnant women, the prevalence of insomnia was 52.2% (1). Interestingly, 
in a longitudinal evaluation, Facco, Kramer, Ho, Zee, and Grobman (2) found significant 
increases in insomnia from early (38%) to late pregnancy (54%). Higher rates of 61.9% were 
found in another study where 2,816 women who were 32 weeks pregnant completed self-
report sleep quality assessments (3). Using a conservative prevalence estimate of 20%, numbers 
suggests that over 77,000 Canadian women experience insomnia during pregnancy each year  
(4).    
 
Insomnia and maternal and infant outcomes. Insomnia during pregnancy has consequences for 
maternal and child health. For example, insomnia in pregnancy has been associated with 
numerous pregnancy complications including: preeclampsia, preterm birth and growth 
retardation (5). Experiencing poor sleep quality in pregnancy has been shown to predict poor 
newborn sleep (6) and symptoms of maternal postpartum depression (PPD) (7, 8). In fact, 
experiencing a sleep trajectory characterized by consistent poor sleep quality in the perinatal 
period or development of poor sleep quality in the third trimester of pregnancy has been 
associated with ten to twenty-fold increases in the risk of experiencing symptoms indicative of 
PPD, even after controlling for robust predictors of PPD such as depression in pregnancy, and 
socioeconomic status (8). PPD is itself associated with numerous negative child outcomes (9).  
Treatment of insomnia in pregnancy. Treating antenatal insomnia with pharmacotherapy 
effectively improves sleep quality and confers a protective benefit against the onset of PPD 
(10); however, recent best practice guidelines advise against the use of sleep medications in 
pregnancy due to potential teratogenicity (11). Additionally, data suggests that the majority of 
pregnant women are reluctant to take prescribed medications due to their perception of risk 
(12, 13). Results from a recent study conducted in our lab, assessing patient perceptions, found 
that when presented with descriptions of pharmacotherapy versus cognitive behavioural 
therapy for insomnia (CBT-I), pregnant women rated  CBT-I as significantly more credible and 
indicated that it was a preferable treatment for insomnia experienced in pregnancy when 
compared to pharmacotherapy (14).  
 
Cognitive Behavioural Therapy for Insomnia (CBT-I). CBT-I is an evidence-based 
psychotherapeutic intervention that combines cognitive and behavioural principles to provide 
psychoeducation about thoughts that contribute to the maintenance of sleep problems, and 
instruction in behavioural techniques to help participants decrease sleep onset latency and 
promote effective sleep maintenance. A large body of research has demonstrated that CBT-I is 
an effective treatment for insomnia, with short-term efficacy equivalent to medication, and 
long-term results suggesting that it outperforms medication. For example, in a review of 

Sleeping for Two Study Research Protocol 4  
  
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randomized controlled trials that assessed the comparative effectiveness of CBT-I and 
pharmacological interventions for insomnia, it was found that CBT-I was more effective than 
benzodiazepine and non-benzodiazepine drugs in the long term (15). Additionally, meta-
analysis suggests that effect sizes of CBT-I range from medium to large both at post-treatment 
and follow-up assessments (15), prompting researchers to recommend primary care providers 
to consider CBT-I as the first treatment option for insomnia (16).   
Online CBT-I. Despite an encouraging body of evidence supporting the use of CBT-I for 
treatment of insomnia and treatment with CBT-I is not easily accessible to all pregnant women. 
There are also a lack of well-trained CBT-I therapists and far fewer than would be needed to 
provide services to the vast number of North American women suffering from insomnia in 
pregnancy. To address this issue, researchers have turned to online administration of CBT-I 
(iCBT-I; 17). Two systematic reviews and meta-analyses suggest that iCBT-I is effective at 
reducing symptoms of both insomnia and depression (18, 19). For the treatment of insomnia, 
administration of iCBT-I has been shown to be comparable to face-to-face intervention (18, 19).  
CBT-I in the Perinatal Period. Pregnant women have traditionally been excluded from 
intervention research and insomnia treatment is no exception, prompting calls for further 
development of interventions to treat insomnia in pregnancy and the postpartum (20). To our 
knowledge, there has only been one open pilot study examining the effectiveness of CBT-I in 
pregnancy, which was conducted by our lab. The intervention was delivered to thirteen 
pregnant women with insomnia and results suggest that CBT-I was effective and acceptable in 
reducing both subjective symptoms of insomnia and improving objective indices of sleep 
quality; in fact at the end of treatment 12/13 participants said they were no longer experiencing 
clinically significant symptoms of insomnia (21). Additionally, the intervention was acceptable 
to participants with 100% of women who began treatment successfully completing the 5-
session protocol.  
The majority of women entered the study reporting elevated depressive symptoms and 
experienced a significant decline in depressive symptoms in the follow-up period, a finding that 
has been observed in other populations (22, 23). These results are encouraging, as recent 
trajectory analyses from our group show that without intervention, disturbed sleep and 
depressive symptoms are relatively stable or increasing in the perinatal period (24, 25). Further, 
results from a systematic review and meta-analysis currently being conducted in our lab, which 
includes over 4,000 subjects, suggests that on average sleep quality declines significantly from 
early to late pregnancy; in contrast, group treatment with 5-sessions of CBT-I significantly 
improved sleep quality, even as pregnancy progressed.   
Objectives  
 
The primary aim of the current project is to evaluate the impact of a 6-week in-person CBT-I 
versus iCBT-I versus a waitlist (WL) in reducing symptoms of insomnia (assessed subjectively by 
self-report and objectively with actigraphy) experienced in pregnancy. We hypothesize that 

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participants who receive a 6-week program CBT-I and iCBT-I (versus WL) will report fewer 
insomnia symptoms and have improved objectively assessed sleep as measured by at one-week 
(T2) post treatment. Based on previous research findings, we do not expect that there will be a 
difference between in-person CBT-I and iCBT-I administration.  
The secondary aim is to investigate if CBT-I versus WL reduces symptoms of depression at T2 
(one week post-treatment). We hypothesize that participants who receive CBT-I and iCBT-I 
(versus WL) will report fewer depressive symptoms as measured at T2.  
METHODS  
Trial Design  
The proposed study is a randomized controlled trial of the efficacy of CBT-I for the treatment of 
insomnia experienced during pregnancy compared to WL. Assessments will occur at baseline, 
between 12-30 weeks of pregnancy (T1), and at one week posttreatment (T2).  
Recruitment Strategy  
Participants will be recruited through Low Risk Maternity Clinics associated with Primary  
Care Networks, the Perinatal Mental Health Clinic, and the Foothills Medical Center Women’s 
Mental Health Centre. Participants will also be able to self-refer to the study through several 
other methods including through posted announcements and pamphlets available in the main 
areas of family medicine clinics, midwifery clinics, ultrasound clinics, holistic/chiropractic clinics 
and other areas (community centres, libraries, and children’s stores). Participants will also be 
recruited through advertising on Internet (Healthy Hearts Lab website, Healthy Hearts Lab 
accounts on Twitter and Facebook). Media releases about the study may also occur in print 
media, on the radio, and television. In any media releases, active recruitment will not occur; 
however, the study investigator would give general information about the study, potentially in 
an interview. A research assistant will explain the study protocols involved in the project to 
interested participants. If a participant meets the inclusion criteria and agrees to be involved in 
the study, a baseline assessment will be conducted in the two weeks prior to the start of the 
intervention.  
Inclusion and Exclusion Criteria  
Inclusion: English speaking women over the age of 18, between twelve and thirty weeks of 
gestation, and identify as experiencing insomnia in pregnancy. Insomnia will be diagnosed using 
the Insomnia Interview Schedule (IIS).  
Exclusion: Experiencing symptoms of other sleep disorders (i.e. restless legs syndrome, sleep-
disordered breathing); history of untreated, serious psychiatric illness (i.e., bipolar disorder, 
schizophrenia); currently taking prescribed medications for sleep problems; smoking, drinking 
alcohol or drug abuse during pregnancy.    

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Pregnant women interested in study participation will contact the Healthy Hearts Laboratory 
and will receive additional information about the study protocols involved in the project. If a 
participant agrees to take part in the study, she will answer a series of questions during a 
phone-screening questionnaire (Insomnia Interview Schedule) (21). Potential participants who 
will not meet the inclusion criteria (e.g., reporting mild sleep problems) will be provided by 
email with a resource list of community services for pregnant women. Pregnant women 
excluded from the study for smoking, alcohol use, and/or drug use will also be provided with a 
list of community services, and referred to their primary care physician.   
Prospective participants who agree to be involved in the study will meet with a member of the 
research team, who will explain the study procedures in full detail and obtain written consent. 
After consent has been obtained, participants will also be administered a diagnostic interview 
(Structured Clinical Interview for DSM-5; SCID) to assess if any exclusionary criteria are present 
and collect information about Axis 1 mood disorders (26). Assessments will be conducted by 
master’s students in clinical psychology, under the supervision of a licensed clinical 
psychologist. Screening for Restless Legs Syndrome (RLS) and sleep-disordered breathing (SDB) 
will be conducted using the Cambridge-Hopkins questionnaire for Restless Legs Syndrome (CH-
RLSq) and STOP questionnaire, respectively; women whose scores are suggestive of a sleep 
disorder other than insomnia will be referred to their primary care provider for further 
assessment.  
Procedures  
Week 1 (T1): Eligible participants will meet with a member of the research team, who will 
explain the study protocols and obtain written consent. After completing a demographic and 
health practices questionnaire, women will be asked to read and complete self-report 
assessments of emotional and physical manifestations of fatigue, emotional health, social 
support, and sleep quality and quantity. Please see Figure 1 for a research design flowchart.  
Once complete, participants will be provided with an actigraphy device and instructed on how 
to use it. They will be asked to wear the device for a period of 7 days during and send it back in 
a prepaid, stamped, envelope which will be provided at their study visit.  
 
Participants will be randomly allocated to in-person CBT-I or iCBT-I or WL. Randomization will 
be determined using an online research randomization tool (27), which is not predictable and 
eliminates potential experimenter bias (28). Forty-five participants will be enrolled in the pilot 
RCT, with 15 randomized into each study group. A staff member who is not associated with the 
study will conduct the randomization and sequence generation and will put each participant 
assignment into opaque envelopes that contain the results of the randomization. After a 
baseline assessment is completed a study therapist will open an envelope and inform 
participants of their assignment.   

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Participants randomized to in-person or online treatment will be invited to participate in 6 
sessions of CBT-I. Participants randomized to the waitlist group, will receive a pamphlet with 
information about community resources for pregnant women.  
Week 2- Week 7: If randomized to the in-person treatment group, participants will be invited to 
attend 6 in-person sessions of cognitive-behavioural therapy for insomnia, which will take place 
at the University of Calgary in a newly renovated research space (see Appendix A for the 
structure of each session). Additionally, they will receive a manual which will include weekly 
readings relevant to the material being taught in the sessions and an informational pamphlet 
with helpful community resources for pregnant women. During this intervention, they will 
become familiarized with self-management approach for insomnia, sleep basics and sleep 
restriction, stimulus control, problem solving to cope with sleep disturbances and relapse 
prevention.  
Participants randomized to online cognitive behavioural treatment (iCBT-I) will complete a 
series of 6 modules, where the main learning components are included in video and audio 
materials. To log onto the CBT-I intervention website, participants will be given login 
information through an anonymized email address, which will be used only for the duration of 
the study. Like the in-person intervention, the iCBT-I intervention includes instruction and 
homework on sleep hygiene and relaxation strategies. Participants will be contacted regularly 
by a member of the study team to ensure that there are no issues with accessing online 
readings and audio/visual materials (29).  
Participants in the waitlist group will receive regular obstetric care provided according to the 
needs and current regime of the patient. The amount of contact with health care professionals 
outside of the study will be reported, as well as any treatment for insomnia (e.g., medication 
use) that the control participant engages in.  
 
Week 8 (T2): After 8 weeks, all the participants will be invited to complete the same set of 
questionnaires from the baseline assessment. Additionally, they will be provided with an 
actiwatch and asked to wear it for seven days during weekdays. WL participants will be offered 
the opportunity to access the iCBT-I treatment. 
3-Months Postpartum (T3): At 3-months postpartum, all participants will be invited to a web-
link with the same set of questionnaires from the previous points of assessment, as well as one 
additional questionnaire assessing infant sleep quality. The web-linked questionnaires are 
expected to take approximately 30 minutes to complete. 
Equipment  
Participants will be provided with an actigraphy device (Actiwatch II, Phillips, USA) and asked to 
wear it for 7 consecutive days at each assessment point.   
  

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Outcome Measures  
Complete descriptions of outcome measures are provided in Table 1.  
Primary Outcome Measures  
Insomnia Interview Schedule (IIS), Insomnia diagnosis will be confirmed using the IIS, which 
produces reliable and valid insomnia diagnoses, and provides information about developmental 
course and impact (21).   
Insomnia Severity Index (ISI) (21, 30, 31). The ISI is a 7-item questionnaire designed to identify 
cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, 
sleep maintenance and early wakening problems, sleep dissatisfaction and perceived distress 
caused by sleep problems and it was found to be a clinically useful tool in assessing changes in 
insomnia symptoms in insomnia treatment research (31).   
Pittsburgh Sleep Quality Index (PSQI). The PSQI instrument is used in assessing one’s sleep 
quality during the previous month. It consists of 19 self-rated items and 5 questions rated by 
the roommate or bed partner.  There are seven components of the PSQI and these are 
subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep 
disturbances, use of sleeping medications and daytime dysfunction. A score higher than 5 
suggests poor sleep quality (32).  
For assessing sleep quantity and quality, actigraphy (Actiwatch II, Phillips, USA) and sleep daily 
logs will be used in this study. Actigraphy monitoring provides objective information on 
circadian rhythm amplitude, acrophase, and mesor as well as indices of sleep efficiency, sleep 
latency, total sleep time, and number and frequency of awakenings (33). Participants will be 
asked to wear the actigraph for a period of 7 days at each assessment point.   
 
Secondary Outcome Measures  
Edinburgh Postpartum Depression Scale (EPDS) (34). Symptoms of depression in pregnancy 
and the postpartum will be assessed by the EPDS. The EPDS consists of 10 items and is a reliable 
and valid tool for identifying symptoms of depression experienced in pregnancy and the 
postpartum (35).  
Additional Measures and Questionnaires  
Additional questionnaires include the Multidimensional Fatigue Symptom Inventory- 
Short Form (MFSI-SF) (36), Dysfunctional Beliefs and Attitudes about Sleep  
Questionnaire (DBAS-16) (37), Sleep Self-Efficacy Scale (SES) (38), Sleep Hygiene  
Index (39), Pre-Sleep Arousal Scale (40), Glasgow Sleep Effort Scale (41), Sleep-Related 
Behaviors Questionnaire (SBRQ) (42), Epworth Sleepiness Scale (ESS) (43), Edinburgh Postnatal 

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Depression Scale (EPDS) (88), Generalized Anxiety Disorder (GAD-7) (44), Couple Satisfaction 
Index (CSI-16) (45), the Big Five Inventory (BFI-44) (46), the Extended Brief Infant Sleep 
Questionnaire (BISQ) (47), the Pregnancy-Specific Anxiety Measure (48), the PROMIS Adult 
Version 1.0 Pain Interference Short Form 8a (49), and the PROMIS Adult Version 1.0 Pain 
Intensity Short Form 3a (49).  
Data will also be collected regarding demographic and psychosocial variables known to impact 
sleep. Demographic information collected will include age, family socioeconomic status, and 
number of children at home. Health practices assessed include smoking, alcohol consumption, 
and level of habitual exercise. Assessment of previous mental health problems, sleep disorders 
and psychotropic medication use will be assessed via interview.  
ANALYSIS PLAN  
  
Sample Size Power Calculation  
The primary response variable, change in symptoms on the Insomnia Severity Index (ISI) 
between baseline (T2) and post treatment follow-up (T2), will be analyzed with using Repeated 
Measures Analysis of Variance (ANOVA) with a linear distribution specified at a significance 
level of α = 0.05. Using data from our pilot study, and insomnia symptoms on the ISI, we found 
that pre-post treatment yielded a d = 3.07. Prior studies of CBT-I for patients with insomnia 
have found large between-group effect sizes in a range from d =1.1 to d = 1.6, even in patients 
with comorbid mental illness; however, we completed our power calculations using a more 
conservative effect size estimate, which showed that 18 patients are required to have a 95% 
chance of detecting a between-group effect size of d = 0.8 at a significance level of α = 0.05 on 
the ISI. Although we had no attrition from our pilot study, we added a potential attrition rate of 
20%, resulting in 14 participants to detect group differences in our pilot RCT.   
 
Based on previous research, we do not expect to see differences in iCBT-I versus in person CBT-
I; however, we expect that both conditions will outperform the WL group. Although we had no 
attrition from our pilot study, we calculated a potential attrition rate of 20% based on previous 
research in this area, resulting in 45 participants in our pilot RCT. Across 3 arms, this will allow 
14 participants in each group and will provide a power of more than 90% to detect a difference 
of 8 points on the ISI, which is indicative of a clinically significant change (30).  
Primary Aims  
Hypothesis 1) Participants who receive in-person and online CBT-I (versus WL) will report fewer 
insomnia symptoms as measured by Insomnia Severity Index (ISI) at the post treatment 
assessment point (T2).  
Primary aims will be assessed using Generalized Estimated Equations (GEE) and an intent-to-
treat (ITT) basis, including data for each participant who was randomized, regardless of their 

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adherence to the intervention or whether they withdraw from the study. Analyses including 
only patients fulfilling the treatment will also be conducted.  
 
Secondary Aims   
Hypothesis 2.1) Participants who receive in-person and online CBT-I (versus WL) will experience 
fewer symptoms of depression as assessed by the Edinburgh Postpartum Depression Scale (EPDS) 
and will be less likely to be diagnosed with depression as assessed using Structured Clinical 
Interview for the DSM-IV (SCID) at T2.  
Hypothesis 2.2) Participants who receive online and in-person CBT-I (versus WL) will be less likely 
to be diagnosed with insomnia, as measured by the Insomnia Interview Schedule (21), at T2.  
Hypothesis 2.3) Participants who receive in-person and online CBT-I (versus WL) will experience 
better objective sleep as assessed by actigraphy (higher sleep efficiency and lower sleep onset 
latency) at T2.  
Secondary aims including changes in actigraphy parameters, diagnosis of insomnia, symptoms 
of and diagnoses of depression will be examined. Changes in binary outcomes will be tested 
using Generalized Estimated Equations (GEE) with a binary outcome specified.   
RESEARCH MANAGEMENT  
  
Dr. Tomfohr-Madsen, as the Primary Investigator will be responsible for the overall 
management of the project. She received extensive training in cognitive behavioral 
interventions and will be responsible for training clinical psychology master’s students in the 
delivery of in-person cognitive behavioural therapy for insomnia adapted for pregnant women. 
Dr. Campbell is an experienced clinician and will provide clinical support regarding the 
establishment of therapy protocols and ongoing consultation regarding fidelity to the CBT 
treatment protocol. Dr. Madsen will be responsible for supervising master’s students in 
administering diagnostic interviews for Axis I mood disorders. Dr. Vincent will be responsible for 
supervising the research assistant at the University of Manitoba who will be coordinating the 
online portion of the intervention.   
 
RESEARCH ENVIRONMENT  
  
All assessments and in-person CBT-I sessions will take place at the University of Calgary in a 
newly renovated research space designed specifically for conducting and evaluating evidence-
based interventions which is located in suite 292 of the Education Classroom Building.  
   
  
 

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Sleeping for Two Study Research Proposal 16  
  
Updated: 2017/09/28 
TABLES AND FIGURES 
Figure 1: Research Design Flowchart 

 
Updated: 2017/09/28 
Table 1: Measurement Reliability and Validity  
 
Measure  
Description  
Reliability and Validity  
Insomnia Interview 
Schedule   
Semi-structured interview, used to assess sleep 
history and insomnia complaints among participants. 
Gathers wide range of information about nature and 
severity of sleep problems. Assesses impact of 
insomnia on daytime functioning and quality of life 
[46].  
Provides all relevant clinical information for assessment of 
insomnia, produces reliable and valid insomnia diagnoses [46].  
Insomnia Severity 
Index   
This 7-item questionnaire was designed to detect 
cases of insomnia and evaluate treatment outcomes. 
ISI can be used to assess the severity of sleep onset, 
sleep maintenance and early wakening problems, 
sleep dissatisfaction and one’s perceived distress 
caused by the sleep problems [55, 74].  
Researchers recommended the use of ISI for detecting cases of 
insomnia in the population and for examining treatment 
responses in clinical patients [55, 74].   
Cambridge Hopkins  
Questionnaire for  
Restless Legs  
Syndrome   
Validated, self-report assessment of restless legs 
syndrome. Includes questions designed to exclude 
common health issues that are similar to RLS 
symptomatology [51].    
High specificity (94.4%) and sensitivity (87.2%) [51].  
Previously used among pregnant women with good predictive 
value [75].    
STOP  
Questionnaire  
The 4-item measure includes questions about 
snoring, tiredness during the day, stopped breathing 
during sleep time, and hypertension [52].  
Varied sensitivity of 76-96%, good negative predictive value 
among moderate to severe obstructive-sleep-apnea [52]. Used in 
previous research with pregnant women with great predictive 
value during last two trimesters [76].  
Pittsburgh Sleep 
Quality Index   
Used to assess sleep quality during previous month. 
19 self-rated items, 5 questions rated by roommate 
or bed partner.  Seven components: subjective sleep 
quality, sleep latency, sleep duration, habitual sleep 
efficiency, sleep disturbances, use of sleeping 
medications, daytime dysfunction. Score > 5 suggests 
bad sleep quality [26].  
Excellent internal consistency (Cronbach α of 0.90 and 0.91).  
86.1% sensitivity and 87.7% specificity for a cut-off score of 10. 
Validity confirmed by polysomnographic findings and sensitivity 
in discriminating patients from controls. Diagnostic sensitivity of 
89.6% and specificity of 86.5% [26].  

 
Updated: 2017/09/28 
Multidimensional 
Fatigue Symptom 
Inventory-Short 
Form   
30-item short form version of MFSI consists only 
empirically derived subscales, designed to assess 
general, physical, emotional and mental 
manifestations of fatigue [77]. 
Acceptable psychometric properties, can be safely used as 
substitute for the 83-item original version. Validity confirmed by 
correlation coefficient with relevant instruments (-0.21 to 0.82, 
p<.001), [77]. 
Dysfunctional  
Beliefs and  
Attitudes about  
Sleep  
Questionnaire  
Cognitive scale used for assessing problematic levels 
of unhelpful beliefs about sleep. 16 items, 10-point 
Likert scale ranges from 0 (Strongly Disagree) to 10 
(Strongly Agree). Captures four factors: perceived 
consequences of insomnia, worry/helplessness about 
insomnia, sleep expectations, and medication [78].  
Total scores correlate with insomnia severity, anxiety, and 
depression, as measured by ISI and Beck Depression and Anxiety 
Measures, with adequate temporal stability (r=0.83) [78].   
  
Sleep Self-Efficacy 
Scale   
9-item scale used for measuring one’s level of 
confidence in carrying out specific sleep-related 
behaviors [79].  
Has been found to predict response to CBT treatment for 
insomnia [80, 81].   
Sleep Hygiene Index   13-item self-report items used for assessing presence 
of behaviors thought to compromise sleep hygiene. 
Assesses how frequently behaviors engaged in 
(always, frequently, sometimes, rarely, never). Higher 
total scores indicative of more maladaptive sleep 
hygiene status [82].  
Adequate reliability (Cronbach’s α of 0.66); superior to previously 
published sleep hygiene instruments. Good validity - positively 
correlated with the Epworth Sleepiness Scale {r(269)=0.244, 
p<0.01} and the Pittsburgh Sleep Quality Index total score 
(r(269)=0.481, p<0.01) [82].  
Pre-Sleep Arousal 
Scale  
16-item self-report measure assessing two subscales 
of pre-sleep somatic and cognitive arousal. Five-point 
Likert scale (1, “not at all” to 5, “extremely”) used to 
rate extent to which each item is experienced [83].  
Adequate internal consistency h (α = .76 and .81 for somatic and 
cognitive scales, respectively), and elevated PSAS scores 
associated with sleep onset difficulties [83].  
Glasgow Sleep  
Effort Scale  
Measure of sleep-related effort. Example of an item: 
“I put off going to bed at night for fear of not being 
able to sleep” (Very much/To some extent/Not at all) 
[84].  
Cronbach’s α of 0.77, can discriminate between insomnia patients 
and “good sleepers”. Good predictive value of presence of 
insomnia [84].  

 
Updated: 2017/09/28 
Sleep-Related  
Behaviors  
Questionnaire   
Designed to assess use of safety behaviours to 
promote sleep and cope with tiredness, which are 
associated with impairment in sleep and daytime 
functioning. Scale will help determine effectiveness 
of treatment in reducing the use of unhelpful safety 
behaviours [85].  
Good internal consistency, able to discriminate normal sleepers 
from those with insomnia [85].  
Epworth Sleepiness  
Scale   
It is a self-report 8-item questionnaire producing 
scores from 0 to 24. The scale is designed to assess 
the tendency to fall asleep in situations such as while 
working or driving. Scores greater than 10 suggest 
significant daytime sleepiness [86]. 
The Epworth Sleepiness Scale has good psychometric properties 
[86] correlates with objective measures of sleepiness, and has 
been shown to differentiate between individuals with and 
without sleep disorders [87].   
Edinburgh Postnatal 
Depression Scale 
Useful in identifying women at risk for depression. 
Scale items assess depressive symptoms including 
sleep disturbance, low energy and suicidal ideation 
[59].  
Sensitivity and specificity varies by cut score, however, 
established as useful tool in field of perinatal mental health [88].  
Generalized  
Anxiety Disorder   
Brief measure for assessing symptoms of generalized 
anxiety disorder. Cut scores of 5, 10 and 15 
considered to reflect mild, moderate and severe 
anxiety [89].  
In perinatal research, sensitivity of 61.3% and specificity of 72.7% 
at cut score of 13. Researchers deemed scale useful in detecting 
perinatal anxiety symptomatology [90].  
Couple Satisfaction 
Index   
The CSI-16 scale will be administered to assess 
participants’ relationship satisfaction. Consists of  
16 six-point Likert Scale statements [91]  
  
In comparison with relevant instruments, has higher precision of 
assessment, superior sensitivity for detecting satisfaction 
differences. Strong convergent and construct validity, Cronbach’s 
α of .98 [91].  
Big Five Inventory   
Used for assessing five broad dimensions of 
personality traits (openness, conscientiousness, 
extraversion, agreeableness, neuroticism).  
Includes 44 five-point Likert scale items [92].  
Review demonstrates good reliability and acceptable discriminant 
and convergent validity across several studies [92].  

 
Updated: 2017/09/28 
Actigraphy  
Provides objective information on circadian rhythm 
amplitude, acrophase, and mesor as well as indices of 
sleep efficiency, sleep latency, total sleep time, and 
number and frequency of awakenings. Less costly 
and intrusive than polysomnography (gold standard 
in sleep measurement)  
Satisfactory accuracy (high sensitivity, low specificity), 
recommended as reliable and useful method for assessment of 
sleep (de Souza et al., 2003). Actigraphic estimates for sleep 
percentage and sleep latency correlated 0.82 and 0.90 (p<.0001) 
compared to polysomnography [93].