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CLINICAL REVIEW

Self-report measures of insomnia in adults:rationales, choices, and needs

Douglas E. Moul*, Martica Hall, Paul A. Pilkonis, Daniel J. Buysse

Department of Psychiatry, Western Psychiatric Institute and Clinic, Sleep and Chronobiology Center,University of Pittsburgh, Room E-1119, 3811 O’Hara Street, Pittsburgh, PA 15213, USA

KEYWORDSInsomnia; Methodology;

Questionnaires;

Literature review;

Adults; Priorities;

Criteria

Summary Self-report measures continue to provide key information in the evaluationand treatment of insomnia. While knowledge development about insomnia continuesto require multi-trait, multi-method studies, self-report measures remain central inmost study designs. The available stock of insomnia-related questionnaires has asubstantial heterogeneity in their formats, foci, scopes, and other attributes. Whilethere may be benefits from using specially tailored questionnaires in particularcircumstances, in other cases the information quality of a study will be downgraded bypoor choice of questionnaires. To assist clinicians and investigators in selectingquestionnaires wisely, the present paper reviews questionnaire criteria and attributepriorities for clinical trials, theory tests, observational studies, and aging studiesconcerning insomnia. An extensive table of currently available questionnaires isprovided, and some needs for future questionnaire development are also identified.q 2003 Elsevier Ltd. All rights reserved.

Insomnia has become a topic of increasing interestas more becomes known about the impact ofinsomnia on psychological functioning and physicalhealth. Many kinds of studies are important forresearching insomnia, and many kinds of self-reportinstruments will be needed to investigate it fully.The selection of instrument(s) for a particular studydepends partly upon the definition of insomnia aninvestigator selects. Kleitman made the point that‘hyposomnia’ might be a better term to describethe problem that most people experience. In thehistorical past, ‘insomnia’ denoted any poor sleep-ing (including sleep apnea). However, insomnia nowhas more constrained definitions, all without well-defined polysomnographic (PSG) criteria.1

The International Classification of Sleep Disorders(ICSD) defines mild insomnia as ‘an almost nightlycomplaint of an insufficient amount of sleep or notfeeling rested after the habitual sleep episode’2

The American Psychiatric Association’s Diagnosticand Statistical Manual (DSM) defines PrimaryInsomnia as ‘a complaint of difficulty initiating ormaintaining sleep or of non-restorative sleep thatlasts for at least 1 month,’ along with the presenceof functional impairment or significant distress.3

These differing definitions reflect the lack ofconsensus in defining insomnia as a syndrome. Asa symptom, insomnia is also understood to beintegral to well-defined medical conditions (e.g.depression, pain, head trauma) that, when present,disqualify an experienced insomnia as being psy-chophysiologic or primary. Stated differently, thegeneral construct validity of insomnia as a clinicalproblem is generally acknowledged, yet as a specific

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*Corresponding author. Tel.: þ1-412-624-5281; fax: þ1-412-624-2841.

E-mail address: [email protected] (D.E. Moul).

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syndrome, its construct validity remains proble-matic. Both the ICSD and DSM definitions refer toinsomnia as a collection of symptoms (i.e. com-plaints) rather than as a collection of clinical signs.

Broadly speaking, insomnia research makes useof various approaches in attempting to understandthe causes and consequences of poor sleeping. Self-report questionnaires have remained a mainstay ofinsomnia research for several reasons. First, self-reports remain the primary metric for clinicianswho treat insomnia patients. Second, obtainingself-reports is comparatively inexpensive. Third, inthe absence of biomarkers of insomnia, and in thepresence of competing definitions of insomnia, self-report questionnaires provide key data throughwhich one study may be compared to another. Incontrast to many other syndromes, unique meth-odological problems may arise when studyinginsomnia because some of the subjective andobjective data represent the same phenomena(e.g. sleep latency). The resulting subjective–objective contrasts may challenge the validity ofself-reports of sleep beyond the usual difficulty ofestablishing the semantic validity of self-reports.4,5

The clinical definition of chronic insomniaprobably cannot be based only on self-reports oronly on PSG or other objective measures ofsleeping. For this reason, it is highly important tobe conceptually precise about the relation of self-reports to PSG data. A clear reference point is thatthe validity of PSG data cannot be regarded as anabsolute, monolithic measure of sleep. PSG leads(e.g. C4) report on only a small fraction of thebrain’s activity during sleep, and illuminate littleabout brain activity during waking to correlate withdaytime symptoms of insomnia. Self-reports remaina part of any syndromal definition of chronicinsomnia, and because of this also have validity,albeit a validity different from that of PSG data.While self-reports have this generalized validity, aseparate question asks what relation existsbetween self-reports having different periods ofrecall (e.g. past-night versus past-week). At firstglance, this relation between recall periods appearsto concern validity, or truthfulness, in reporting.However, because self-reporting is inherentlyexperiential rather than strictly ‘factual’, it isclear that these relations are merely phenomen-ological rather than subject to strict tests ofcontradiction. (Interestingly, the same might besaid for comparisons between objective measures.For example, it would make no sense to say thatPSG data from the C4 lead was the ‘objective’measure of sleep state, whereas the data from theF3 lead was not valid because it may not be in strict

synchrony with the C4 lead or present the samedata.)

Self-report data and PSG data can certainly beexamined for their validity in relation to oneanother where they concern the same phenomena,for example, sleep latency. However, self-reportdata may report on sleep-related phenomena thatare currently impossible to measure objectivelywith current technologies. In any case, conceptualdifficulties persist regarding what is actually beingmeasured in current measurement systems. Whilethis conceptual difficulty inhibits confidence incurrent theories about insomnia, it also meansthat there still are many opportunities for research-ing how candidate objective and subjectivemeasures are related to one another. By impli-cation, these difficulties indicate the need formulti-trait, multi-method programs of researchusing various measures associated with subjectiveand objective poor sleeping. For example, a traitsuch as a person’s habitual sleep latency may beresearched with multiple methods of objective andsubjective measurement. Similarly, various traits(e.g. sleep latency, number of awakenings, sleepefficiency) may be investigated with cross-correla-tional methods. In the future, new traits to studymay be identified, and new methods of measure-ment may be developed.

Self-report measures are not the sole data forstudying insomnia, and should be correlated withdata derived from the PSG and other physiologicalmeasures. On the other hand, even if biomarkers ofchronic insomnia become well established, self-report data will remain a vital source of infor-mation. Just as with any other syndrome in clinicalmedicine, a complete explanation of chronicinsomnia will require precise and detailed concep-tual linkages between objective physiologicalabnormalities in insomnia patients and patients’symptoms, as expressed in self-reports.

To assist researchers in selecting instruments,this paper has the following aims: (1) To reviewsome criteria by which insomnia self-report instru-ments may be evaluated, (2) to prioritize differentcriteria for different classes of insomnia research,(3) to review current insomnia-related self-reportinstruments, and (4) to identify self-report instru-ments that are needed.

Measurement domains and criteria

Testing self-report instruments psychometrically isimportant because the average research subjectmight provide imprecise or biased responses in

D.E. Moul et al.178

relation to a questionnaire’s measurement objec-tives. These problematic responses impair accuratescaling of the latent dimensions (e.g. sleep quality,usual sleep length, sleepiness) that the instrumentproposes to measure. Several authors discuss gen-eral methods of assessing instruments.6,7 Inaddition, assessment of an instrument’s feasibility,theory relevance, and other qualities is also import-ant. Furthermore, when variables or instrumentshave different scopes of reference (e.g. particularsymptom versus quality of life), how variables relateto one another becomes an analytic problem.8 Table1 presents an assessment of priorities for selectedgeneral measurement domains and criteria withinseveral research contexts.

Pro and Con: making your owninstrument, or using an established one

Why not just make up ad hoc questions for one’sstudy, as needed? In some cases this is a goodstrategy, particularly if one is venturing into a new

and unique area. Pioneers of new areas need toinvent new questions and instruments, since newtopics require new measures. Designing one’s owninstrument gives one flexibility. However, whensimilar studies already exist, overuse of study-specific measures generally lowers the scientificvalue of a particular study, and of studies ingeneral. An example illustrates what happenedover time in a collection of studies conductedwithout standardized instruments.

A review of randomized, double-blind studies oflonger-term hypnotic use in patients with chronicinsomnia shows that they used a wide variety ofstudy-specific measures. However, several stub-born problems present themselves when one wantsto generalize across these studies. First, subjectswere diagnosed using the different definitions andprocedures. This makes comparisons betweenstudies difficult, and impairs the extrapolation offindings to other research or clinical settings.Second, the measures of outcome werenot uniform. Where one investigator choseself-reported sleep latency as a critical variable,9

Table 1 Priorities for characteristics in various study types.

Domain Characteristics Study type

Clinicaltrials

Theorytest

Epidemiologicalcross-section

Genetics Servicesresearch

Economic

Scaling and scoring Continuous measurement scaling A A B C B ATransparency of scoring A B B C A CItem-response characteristics B A B C B B

Symptoms and impacts Nighttime and daytime symptoms A B A B B CCognitive domains B A C C B CFunctional impairment and qualityof life

A C A C A A

Time and prediction Short time-frame for self-report B A A B B BTreatment responsivity A B C C A APredictive validity C A B B A A

Sensitivity and specificity Sensitivity for caseness C C B C A ASpecificity for caseness C C A A B BPositive predictive value C C A C A A

Instrument burden Brevity of instrument B C A C A BLow costs C B A C A A

Theories and causes Construct validity C A C C B CMeasures potential confounders B A A A B BMeasures causal intermediates C A C B B C

Aspects of care Ease of implementation C C A C A ALinkages to service use C C B C A AAcceptability to end users C C B B A B

Costs and utility Direct cost estimates of care A C A C A AIndirect cost estimates of syndrome C C A C A AUtility assessments A C C C A A

A: high priority; B: intermediate priority; C: low priority.

Self-report measures of insomnia in adults: rationales, choices, and needs 179

another chose self-reported quality of life.10 So forthe question of long-term effectiveness of hypno-tics, the overuse of study-specific measures hascontributed to uncertainties about prescribinghypnotics.

Why not only use well-validated, ‘brand-name’instruments? This may be a good strategy aswell, depending on the circumstances. Validatingquestionnaires requires psychometric testing thatincludes test–retest reliability and validity (i.e.‘truth value’) assessments. Concurrent validity inrelation to insomnia refers to how the instrumentcorrelates to other existing measures of phenomenarelated to chronic insomnia. For example, howrelated is the instrument to PSG measures of sleep,or to other self-report measures of fatigue? Inaddition, discriminant validity testing asks if differ-ent samples of subjects (e.g. insomnia vs.depressed) provide different questionnaireresponses. Completing such psychometric studiesis specialized and time-consuming. Thus, using avalidated, study-appropriate instrument onlyupgrades a study’s scientific value. A researcher iswise to stipulate a study’s specific measurementobjectives carefully and to decide if an availableinstrument meets those objectives.

Before discussing the role that the study aimshave in guiding instrument selection, a few generalcriteria for instrument selection are worth noting.First, is the instrument at the correct reading levelfor the study sample? Second, does the instrumentuse words that local subjects normally use to referto subjective states? For example, a questionnairein Spanish written in Spain may not be suitable foruse in Mexico. Third, does the instrument use wordslargely free of double meanings? For insomniapatients, a particularly difficult word here is‘sleepiness,’ which different patients use variouslyto refer to an actual tendency to fall asleep, tolowered levels of alertness, or to increased feelingsof somatic fatigue. Empirical tests of a words’semantics in the target population may be requiredbefore it can be used in a questionnaire. Finally, isthere a reasonable correspondence between thesample in which the instrument’s psychometricswere studied and the sample in the particular study?

Study aims: some general types

A specific study’s research design might fit into oneof several general categories that occur commonlyand that share rationales for instrument selection.Several considerations can be reviewed whenselecting instruments for a particular study. First,

what general kind of research question is beingasked, considering the study’s specific aims?Second, given the general kind of question, whatare the usual measurement priorities for this studytype? Third, what are the practical constraints ofusing a particular instrument? Lastly, will one ormore established instruments suffice, will someneed to be modified, or will a new instrument needto be invented? We review several general situ-ations by way of illustration, asking these fourquestions in turn. We will avoid review of instru-ments with time frames of one-day (e.g. diaries) or‘now’ (e.g. self-reports at time of awakening)reporting (reviewed by Spielman et al.11), andfocus more on instruments with a week-to-weektime frame.

Scenario 1: efficacy studies

One common study design tests the efficacy of aparticular hypnotic medication or defined beha-vioral intervention, compared to another medi-cation, another intervention, or placebo.

What is the general kind of question that isasked in efficacy studies for insomnia? The generalquestion is whether one can detect a statisticallysignificant difference in one or more defined out-come variables between comparable samples ofsubjects ideally differing only by the specificmedication or intervention to which they wereexposed. Often there are accompanying investi-gations about the safety and side-effects ofmedication(s).

What are the measurement priorities in efficacystudies for insomnia? The attributes of highestimportance are those of treatment responsivity,relative temporal precision, continuous measure-ment scaling, and transparency of scoring, inaddition to broad symptom coverage and overallsummary scoring.

If the goal of the study is to find differencesbetween treatments, one needs to employ ameasure that produces timely and precise numeri-cal changes as soon as the subject experiencessymptomatic improvement in target symptoms.However, the time frame of reporting should beconsidered in relation to the study question. Aweekly time frame of self-report questionnaires is acritical external validity issue for studies thatinvestigate the stability and/or safety of longitudi-nal interventions because that comparison is madeto clinical contexts where only weekly visits areusually possible. ‘Now’ reporting enhances internalvalidity because the self-reporting time frame is

D.E. Moul et al.180

more immediate, but it does not reflect how theweek-by-week and longitudinal effectiveness ofinterventions are usually assessed by clinicians.‘Now’ self-reports are not more or less valid thanweekly self-reports (unless the respondents areconsciously lying) because these time frames ofreporting exist in a phenomenological, and not avalidity, relationship to one another, in the absenceof an ‘objectively’ subjective standard. (Thedebate about long-term hypnotic use has been ill-served by studies using questionnaires and labora-tory-based studies that facilitate only high internalvalidity.)

Breadth of coverage and overall summary scoringprotects the study against individual differences insymptoms or in their semantic descriptions. Trans-parent scoring rules ensure that the data obtainedwill be conceptually and statistically unambiguous.

Attributes of medium priority are scoring ofsymptom subdomains and quality of life. Subdomainand quality of life attributes help localize where thetherapeutic benefits occur. Attributes of lowpriority for efficacy studies include trait measure-ment, high diagnostic specificity, and theoryrelevance. These last attributes are more appro-priate for questions about diagnosis, mechanisms ofdisease, or mechanisms of action, none of which arethe primary focus of efficacy studies.

A special caution is worth noting about symptomsin efficacy studies. If a medication has side-effectsthat resemble the one or more symptoms ofinsomnia (e.g. mild sleepiness, fatigue), thentheir inclusion as items in the outcome measurewill reduce the chances of demonstrating a treat-ment effect.

What practical constraints should be weighed inselecting an instrument for an efficacy study? Onemajor consideration is whether the data collectionprocess may be too burdensome for the subjects sothat they drop out from the study. Too manydropouts degrades a study’s ease and quality ofanalysis, creates potential non-response biases,and decreases the overall likelihood of demonstrat-ing a treatment effect. If the instrument needed isactually an interview conducted by properly trainedclinical interviewers, then the cost of employing,training, and supervising these interviewers can behigh. In some circumstances, data collection maybe possible only using interviews or relatedmethods.

Will one or more instruments suffice to answerthe general outcome question across medicationefficacy studies, or is there a need for betterinstruments? Several instruments have been usedsuccessfully in aiding investigators to establish theefficacy of treatments for insomnia. The Leeds

Sleep Evaluation Questionnaire (LSEQ),12 con-structed for use in medication trials, has beenuseful in documenting clinical change. Morin’sInsomnia Severity Index (ISI)13 has been usedsuccessfully in conjunction with comparisons ofmedication versus cognitive-behavioral treatmentsof insomnia. Spielman’s Insomnia Symptom Ques-tionnaire (SISQ),14 a set of visual analogue scales,has been used quite successfully in documentingtreatment efficacy. The recently described AthensInsomnia Scale (AIS)15 attempts to integrate day-time with nighttime perceptions in one metric, butawaits use in a clinical trial. The Pittsburgh SleepQuality Index (PSQI)16 has robust psychometriccharacteristics related to general sleep qualityand is widely applicable in adult populations. Ithas been used in several efficacy trials. Hoelscher’sInsomnia Impact Scale (IIS)17 covers a broad rangeof subjective distress and cognitive items in auniform Likert-scale format, and has been used inoutcome studies. Jenkins’ Sleep Problems Ques-tionnaire (SPQ)18 asks for the number of nights/dayswith four kinds of sleep difficulties in the lastmonth. To our knowledge, the SPQ has not beenused in efficacy trials. The ISI, SISQ, AIS, PSQI, SPQare brief. The Quality of Life in Insomnia (QOLI)scale19 might also be considered in efficacy trialswhere broader outcomes are considered. The ISIhas been translated into French. The PSQI and QOLIhave been more widely translated.

All these questionnaires appear to have at leastsome psychometric validity, but have limitations asefficacy measures. The current best questionnairesfor week-to-week assessments probably are theLSEQ, ISI and SISQ. The LSEQ asks about bothnighttime and morning domains, but does notinclude subjective sleep parameters, uses thereference to ‘usual’ experience, and is designedfor use in medication rather than behavioral trials.The ISI and SISQ focus mostly on daytime symptoms.The AIS attempts to integrate daytime with night-time perceptions, but does not attempt to obtainsubjective sleep parameters. The PSQI does inte-grate nocturnal and daytime assessments thatinclude parameters, but uses a one-month recallperiod and complicated scoring rules. The SPQ isshort, but without items reflecting subjectivedistress. The IIS focuses more on subjectivedistress, but has a 2-week reporting period. TheQOLI does not query subjective sleep parameters,and contains 51 wordy items in differing responseformats. Yet the QOLI is preferred where quality oflife in relation to insomnia is the main focus. Thepopular SF-3620 is suboptimal in insomnia popu-lations because some of its quality-of-life questions(e.g. ‘Does your health now limit you in…lifting or


carrying groceries?’) relate poorly to the healthconcerns of insomnia patients.

At the present time there is no establishedinstrument best suited to broad-based efficacyevaluations in clinical trials. Recently, our grouphas begun testing the Pittsburgh Insomnia RatingScale (PIRS)21 which we hope will meet this need.Many questionnaires, including the PIRS, have beendesigned to instrument symptoms, rather than toobtain endorsements of improvements. To ourknowledge, no instrument is available with psycho-metrics for use in this ‘positive’ sense, although theLSEQ asks about comparisons to ‘usual.’ Severallimited attempts at designing questionnaires in thepositive style can be found among insomnia efficacystudies.

Scenario #2: testing a theory-basedintervention

Several behavioral and psychological interventionsare available for helping insomnia patients. Theseinclude sleep hygiene interventions, relaxationtraining, stimulus control, sleep restriction, andcognitive therapy. Studies have documented theefficacy of each of these interventions with theexception of sleep hygiene. From a medical point ofview, these interventions must, on principle, berelated to physiological improvements in the sleepof insomnia patients. Medical theories explainingthe physiological mechanisms of action of beha-vioral interventions require studies to actually testthe theories underlying these interventions. Paral-lel requirements are also present for theories aboutthe mechanism(s) of action of pharmacologicalinterventions, yet those theories do not rely asmuch upon self-report data for verification.

What is the general kind of question that isasked in studies of theory-based interventions forinsomnia? These studies ask the general question ofhow the sequence of intermediate outcomes occurduring the intervention to produce the therapeuticoutcome. A related and more discriminating kind ofquestion is whether the therapeutic change occursmore in accordance with one or another particularmechanistic theory of action.

All mechanistic theories about interventions mustprovide time-series predictions that explain theexplicit order in which various phenomena occurduring the therapeutic transformation. At the end ofthe transforming time series, all theories mustprovide the linkage of neural phenomena back tothe self-reportable states that underpin patients’symptom reports. By providing such an account, such

a theory about insomnia therapy explains how anintervention improves sleep onset, maintenance, orquality.These process theories concernantecedents,intermediate outcomes or effects, and final thera-peutic outcomes. For example, in theories explaininghow hypnotic medications work, some intermediateeffectsnormallycitedare thoseof themedicationsonneuronal receptors and ion channels in the chain ofevents that result in patients going to sleep. Intheories explaining how physical interventions (e.g.sleep restriction, hot baths) work, some temporallyprior outcomes concern the physiological effects ofthe physical exposures on intermediate brainphenomena in the path to sleep induction. In thecase of medication-based or physical interventions,this linkage is normally given in a theoretical accountderived from pre-clinical neuroscience (e.g. regard-ing how hypnotics work chemically). Where suchneuroscience is unavailable, the theoretical linkage isdrawn through a time series of phenomenal data,with the theory stipulating what phenomena occurfirst, second, etc., in explicit sequence. Since theneuroscience of behavioral interventions for insom-nia is still unavailable, behavioral theories can nowonly be properly tested in relation to whether theyaccurately stipulate the sequence of phenomenaoccurring in the therapeutic process along the path tothe final therapeutic outcome(s).

What are the measurement priorities in theory-based interventions for insomnia? For theoriesexplaining the mechanism of action of hypnoticsor physical interventions, self-report instrumentsare largely irrelevant as measures of intermediateeffects or outcomes, even while such instrumentsare necessary as measures of final therapeuticoutcomes. For example, the explanation of ahypnotic’s chemical effects on neurons relies in noway on any self-report. The same cannot be claimedfor behavioral or psychological theories. For thelater kinds of theories, the characteristics of theself-report instruments used to measure intermedi-ate effects in a causal series becomes criticalbecause it is such data that are needed tosubstantiate whether the particular theoreticalmechanism occurs as postulated. With theory-testing studies, the study goal is not so much toadvance knowledge of effects as it is to advanceknowledge of causes.

The highest priority attributes in such circum-stances are treatment responsivity, constructvalidity, theory-relevant process measurement,and high temporal precision. Here, theoriesstipulate two main requirements: particular latentvariables and temporal sequences. The instru-ment(s) should have theory-driven construct val-idity for those latent variables that change during

D.E. Moul et al.182

the therapeutic intervention(s). For example, if atheory postulates that insomnia patients arecognitive worriers, then the selected instru-ment(s) should quantify cognitive worrying faith-fully in relation the postulated theory in orderthat the study may substantiate the theory.Theory-postulated intermediate states should bewell instrumented with high (even instantaneous)temporal precision in order to test whethertherapeutic processes are accurately predictedby the theory. For example, if a theory states thatdysfunctional cognitions mediate between theintention to sleep and sleep itself, then someinstruments are required to measure such cogni-tive events in exact temporal series. In this case,it would be highly important to select a self-report instrument with a short recall period, andfrankly wrong to select a self-report instrumentwith a long recall period. If the instrument(s)cannot place intermediate events exactly in thepostulated event series, then the study designcannot comment on whether the theory is true,false, or misattuned.

Medium-priority attributes for theory-testingstudies are continuous measurement scaling, speci-ficity, and trait measurement. These attributes canbe important, depending on the circumstances.Continuous measurement scaling may be critical forstatistical power considerations. If the theory isspecific to one kind of insomnia, then specificity inthat sense may be rather important. Likewise, traitmeasurement may be important for identifying thosepsychological types for whom the theory is especiallydescriptive. Lower priority attributes are widesymptom domain, quality of life measurement,transparency of scoring, or transportability to usualclinical settings. These last attributes are generallyunimportant because the design tests a theory, not afinal outcome or ordinary clinical feasibility.

What practical constraints should be weighed inselecting an instrument for a theory-testing study?An instrument’s everyday practicality is notimportant for a theory-testing study. Testing atheory usually requires ‘laboratory-grade’ con-ditions with high internal validity, where thesample and therapeutic exposures are very care-fully characterized. Using less than ‘laboratory-grade’ measurements actually contradicts theunderlying research aim. It is a sad calamitywhen a theory-based study lacks the design qualityto test the postulated theory because of poorinstrument selection: No new knowledge becomesavailable. For theory-based studies, investigatorsare wise to select subjects willing to completeexhaustively all the therapeutic interventions andmeasurement activities. Such selection will create

sampling biases, yet the presence of samplingbiases is only a secondary consideration in theory-testing studies.

Will one or more instruments suffice to answertheory-testing question across studies, or is there aneed for better self-report instruments? Severalestablished questionnaires can be productivelyused for some theories and some purposes. Sincemany theories are relevant in insomnia research,Table 2 provides a listing of questionnaires thatinvestigators have used to address theories inrelation to insomnia. In constructing this table,we refrained from providing reliability and validitydata because we believe it is the responsibility ofindividual investigators to ascertain whether par-ticular instruments have reliability and validity intheir own samples and research contexts.

On general review, many of the questionnairesaddress process theories only indirectly, or rep-resent outcomes rather than precursors. Forexample, the SII was constructed with a conceptionthat dysfunctional cognitions are an importantinterference in the sleep of insomnia patients.This seems intuitively correct. Yet the SII does nothave the temporal resolution necessary to confirmor disconfirm this clinical theory. Instead, itsquestions are more focused at a dispositional (e.g.‘Are you now the kind of person who…’) time-scale.In the past, the Minnesota Multiphasic PersonalityInventory was used in this way, too, but withvariable results. Helpful theories have been con-structed at dispositional levels of time-scale, yet itis not clear how to use such research predictively inclinical or psychophysiological laboratory settingsbecause dispositional notions are probabilisticrather than deterministic in their predictivecapacity. Furthermore, if the sleep patterns ofinsomniacs behave chaotically in the mathematicalsense, then currently available questionnaires arepoorly suited to elucidating causal processes ininsomniac patients.

If a study focuses on a theory’s generalizability innew populations, then using a theory’s standar-dized instrument is rather mandatory. A goodexample of a theory-based measure is Morin’s useof the SII and related instruments22 that track thecognitive aspects of insomnia patients. Morin’s owntherapy-optimizing studies focus on patients withprimary insomnia. However, if one wanted to knowwhether the same theory also applied to bipolardisorder patients with insomnia, then using the SIIwould be clearly important. On the other hand, if aninvestigator has a new intervention based on a newtheory, then using a well-standardized instrumentsimply because it is well known may not properlytest the new theory. Investigators need to use or


Table 2 Selected conceptual frameworks in insomnia research and related questionnaires.

Conceptualframeworka

Questionnaire Time-frame Commentsb

SleepSleepevaluation

Diagnostic questionnaires are desirable;however, the validity of these questionnaires tofinal diagnoses is not established

Sleep DisordersQuestionnaire37

Indefinite One hundred and seventy-five five-point scaleitems; directed at diagnosis. Subscalesc forsleep apnea, periodic limb movement disorder,narcolepsy, and psychiatric sleep disorder

Sleep questionnaire andassessment of wakefulness38

Indefinite Eight hundred and sixty-three mixed-formatitems; directed at exhaustive survey of causesand consequences of sleep problems of all types

Basic nordic sleepquestionnaire (PNSQ)39

Past 3months

Twenty-one mixed-format items. Domains ofsleep patterns, insomnia symptoms, snoring,excessive sleepiness

Dutch sleep disordersquestionnaire40

Indefinite One hundred and seventy-six five-point scaleitems; directed at diagnosis. Domains ofhealthy, depression, narcolepsy, and apnea

Lacks’ sleep historyquestionnaire41

Indefinite Forty-eight mixed-format items; designed tofocus diagnostic questioning in a structure sleephistory interview

Post-sleepevaluation

‘Now’ instruments have the greatest intuitiveappeal for ‘accurate’ reports, but theirrelationships to reports from other time framesneeds clearer description. These instrumentsfocus on the past night

VSH sleep scale42 Today Eight VAS (Visual Analogue Scale) items forhospital patients. Domains of fragmentation,length, delay, and depth

Sleep and signs and symptomsquestionnaire43

Today Eleven mixed-format check-box items formedication studies. Domains of sleepparameters, sleep quality, awakening quality,medication effectiveness, and dreamdisturbance, with additional clinician-ratedside-effect items

The post-sleep inventory44 Today Thirty thirteen-point-scale items. Domains of‘going to bed,’ ‘during the night,’ and ‘onawakening.’ Factors of mental activity,morning factors, sleep factors, evening/nightailments, dream amount, sleepiness in evening,and dream emotion

Wolff’s morning questions45 Today Eight Yes/No items. Reports onmedication/pillow use, bedpartner presence,sleep onset difficulty, awakenings, sleep length,morning restedness

St. Mary’s hospital sleepquestionnaire46

Today Fourteen mixed-format items, many withcheckboxes. Reports on sleep parameters,sleep quality, awakenings, sleep onsetdifficulty, morning alertness. Available inFrench47

Kryger’s subjectivemeasurements48

Today Nine mixed-format items. Reports on sleepparameters, sleep quality, sleep onsetdifficulty, awakening quality

Morning sleep questionnaire49 Today Four mixed-format items: sleep onset difficulty,sleep length, sleep depth, and sleep goodness

Subjective evaluation ofsleep50

Today Six VAS and three sleep parameter items.Domains of various specific sleep qualities andmorning restedness

(continued on next page)

D.E. Moul et al.184

Table 2 (continued)



Schlaffregebogen A (SF-A)51 Today Twenty-three mixed-format items written inGerman. Domains of sleep quality, post-sleepevaluation, evening psychological composure,evening psychological exhaustion, and somaticsymptoms in sleep

Sleep quality ‘Sleep quality’ is a term of art. Yet thereremains a need to assess poor sleeping and itsconsequences in a comprehensive fashion

Pittsburgh sleep qualityindex16

Past month Nineteen mixed-format items and fiveroommate-rated items. Algorithm for globalscore from components of sleep quality, sleeplatency, sleep duration, habitual sleepefficiency, sleep disturbance, use of sleepingmedication, daytime functioning. Available innumerous languages

Sleep questionnaire52 Indefinite Fifty-nine mostly five-point-scale items;Eighteen scales derived. Factors of sleep depth,difficulties waking, sleep latency, negativeaffect/dreams, sleep length, dreamrecall/vividness, sleep irregularity. Some scales(e.g. masculine/feminine) go beyond themes inother scales

Sleep disturbancequestionnaire53

Indefinite Twelve five-point-scale items. Factors of‘mental anxiety,’ ‘stress problem pattern,’ and‘physical tension’

Schlaffregebogen B (SF-B)51 Past 2 weeks Twenty-nine mixed-format items written inGerman. Factors of sleep quality, post-sleepevaluation, evening psychological composure,evening psychological exhaustion, somaticsymptoms in sleep, dream recall, sleep–wakeregulation

Sleep onset Sleep latency is an obvious focus forquestionnaires on insomnia. The process ofsleep onset should be more completelyinvestigated, both clinically and scientifically

Nocturnal sleep onset scale(NSOS)54

Past 2 weeks Two four-point-scale items: Difficulty fallingasleep, taking ,5 min to fall to sleep

Genericoutcomes

Relatively theory-independent outcomemeasures are desirable for enablinggeneralizable comparisons of results acrossvarious kinds of efficacy and theory-basedstudies

Spielman insomnia symptomquestionnaire (SISQ)14

Past week Thirteen VAS items covering nighttime anddaytime symptoms

Athens insomnia scale (AIS)55 Past month Eight four-point-scale items covering nighttimeand daytime symptoms

Pittsburgh insomnia ratingscale (PIRS)21

Past week Sixty-five four-point-scale items. Domains ofnighttime/daytime symptom distress, sleepparameters, and quality of life. Underevaluation. Available from the authors of thispaper.56

Leeds sleep evaluationquestionnaire (LSEQ)57

Indefinite Ten VAS items with some comparing experiencewith a hypnotic to that of usual experience.Asks about sleep onset, sleep quality,awakening quality. Available in French47

Epidemiology Epidemiological studies provide prevalencedata, allow development of new hypotheses,and inform public health polices about insomniaand its treatments



Table 2 (continued)



Angst’s questions58 Indefinite Ten VAS scale items. Covers nighttime sleepdifficulties, panic, nightmare, being unrested,daytime sleepiness, sleep worry.

Chevalier’s questions59 Past month Three three-point-scale items for nighttime(sleep latency .20 min, difficulty returning tosleep, ,6 ho sleep) and one three-way(tired/irritable/neither) daytime item

Hatoum’s questions60 Indefinite Five Yes/No items. Insomnia graded into Level Iand Level II severity

Sleep problemsquestionnaire18

Past month Four five-point-scale frequency items: troublefalling asleep, waking up at night, troublestaying asleep, awakening tired

Leger’s Q1 Questionnaire61 Indefinite Four three-point-scale items written in French.Estimates diagnoses of DSM-IV primaryinsomnia, grading insomnia into mild and severe

SLEEP-EVAL30 Various Computer assisted personal interview (CAPI)system in which an interviewer asks verbatimquestions given by the computer. It makesdiagnostic classifications for DSM, ICSD, and ICDsystems under conditions of inferentialuncertainty. Translated for use in severallanguages

Composite internationaldiagnostic interview (CIDI)29

Various Historical descendent of the DiagnosticInterview Schedule. Able to make DSM and ICSDdiagnostic estimates with a structuredinterview

Behavior therapiesSleephygiene

A generally useful clinical focus, yet definitionsof sleep hygiene vary, and appropriate sleepbehaviors may vary by age group

Sleep hygiene awareness andpractice scale41

Past week Actually three scales: Sleep Hygiene Knowledge(13 seven-point-scale items), CaffeineKnowledge (18 Yes/No items), and SleepHygiene Practice (19 items countingdays/nights of particular activities)

Sleep behavior self-ratingscale62

Indefinite Twenty five-point-scale items. Contrastsbedtime and daytime items

Sleep hygiene questionnaire63 Indefinite Ten Yes/No items asking about particularpractices

Sleep behaviors scale: 60 þ 35 Indefinite Thirty five-point-scale items. Factors of activebehaviors (11 items), relaxation (8 items), andcognitive arousal (5 items). Normed on an agingsample

Relaxationtraining

Scales for rating physical tension have beenrather overlooked, and are needed to helpdistinguish somatic from cognitive stimuli thatmay interfere with sleep in insomnia patients

Tension thermometer35 Now A single VAS from ‘not at all tense’ to ‘verytense’

Stimuluscontrol

A useful motivating concept for manybehavioral interventions. For clinical andtheoretical reasons, more specificity in stimulusidentification and specific stimulus-responsepatterns is needed

Practice record-stimuluscontrol41

Today Six mixed-format daily items for clinical loggingacross one week


D.E. Moul et al.186

Table 2 (continued)



Sleeprestriction

Sleep log data addresses the therapeuticmechanism of sleep restriction because theyprovide subjective sleep parameters

The Pittsburgh sleep diary64 Today Twenty-three complex mixed-format items.Records daily food and drug intakes, sleepparameters, nocturnal events, daytime naps,exercise, and ratings of sleep quality, mood andalertness

The Karolinska sleep diary65 Today Thirteen mixed-format items plus a derivedsleep efficiency items. Records sleepparameters and sleep quality items

DGSM-Abend/MorganProtokollefur Schlaffuntersuchungen66

Today Twenty-seven complex mixed-format itemswritten in German with separate evening andmorning reports. Reports daily food and drugintakes, sleep parameters, nocturnal events,daytime naps, sleep hygiene, and bedtimearousing-stimulus items

Johns’ Instrument67 1 Week Eleven mixed-format items. Reports sleepparameters by weekday/weekend, sleepquality, nightmare frequency

Sleep questionnaire68 Today Nine mixed-format items with item definitions.Reports sleep parameters, napping, qualityrating, and medication use. Designed for use inaging samples

Morin’s sleep diary22 Today Ten mixed-format items. Reports sleepparameters, napping sleep aid/alcohol use,morning refreshment and sleep restedness

Lacks’ daily sleep diary41 Today Ten mixed-format items. Reports some sleepparameters, with items on sleep difficulty,mental/physical activation, and daytimefunctioning

Visuelle Analogskala zurErfassung vonSchlafqualitat (VIS-A)69

Today Twenty-eight mixed-format items written inGerman. Has evening (daily feeling summaries,napping report) and morning (awakeningquality, sleep parameters) sub-forms

Cognitive-behavioral

The cognitive perspective postulates thatadverse mental events occur between theintention to sleep and actual sleeping. Thoughtsinterfere with sleep in many patients. In some,the interfering events are images. Still othersidentify no mental events interfering withsleep. Thus, many questionnaires are neededfor the cognitive perspective on insomnia

Insomnia severity index13 Past week Seven five-point-scale items. Domains ofinsomnia severity, sleep worry, functionalimpairment, social concern, and sleepsatisfaction

Dysfunctional beliefs andattitudes about sleep scale22

Indefinite Thirty VAS items. Themes of consequences ofinsomnia, control and predictability of sleep,sleep requirement expectations, causalattributions of insomnia, and sleep-promotingpractices

Dysfunctional beliefs andattitudes about sleep scale-10

Indefinite Ten items from the DBAS. Factors of immediateconsequences, long-term consequences, andneed for control

Fragebogen zuschlafbezogenenKognitionen70

Indefinite Thirty four-point-(never to always)-scale itemswritten in German. Factors of sleep anxiety,catastrophizing, self-composure, positive self-instructions, and beliefs about medication use



Table 2 (continued)



Penn State worryquestionnaire: past week71

Past week Fifteen six-point-scale items. Focused ongeneral pathological worrying, possibly distinctfrom sleep worry

Hewitt’s multidimensionalperfectionism scale72

Indefinite Fifteen seven-point-scale items in publication;45 items discussed. Domains of self-orientedperfectionism, other-oriented perfectionism,social prescribed perfectionism. Perfectionismis a possible impediment to sleep

Anxious self-statementsquestionnaire73

Past week Thirty-two four-point-scale frequency-baseditems. Factors of a) inability to maintain copingand a negative view of the future, b) self-doubt/questioning, and c) confusion and worryabout future plans

The Self-Statement Test:60 þ 74

Indefinite Thirty-four five-point-scale frequency-baseditems asking about thoughts duringwakefulness. Factors of generalized positivethinking, generalized negative thinking, andsleep-related thoughts

Post-sleep evaluationquestionnaire

Today Twenty-eight VAS items with Yes/No lead-inbranch points. Asks about thoughts, mentalimages, emotions, and bodily sensations thatoccurred during prior night’s sleep onset.Available from the authors of this paper

Floyd-Medler sleep beliefsscale75

Indefinite Twenty-five five-point-scale items for use innormal adults. Dimensions of next-dayconsequences, health consequences, sleepneed, psychological consequences, sleepregularity, white noise, coping strategies,sleeping in, and napping

Expectancyandacceptability

Treatment effectiveness may depend upon howthe patient views the insomnia problem or theoffered treatment

Self-efficacy scale41 Indefinite Nine five-point-scale items. Describes self-efficacy about sleeping

Insomnia treatmentacceptability scale22

Indefinite Sixteen VAS items. Domains for behavioral andpharmacological treatments

Impacts and statesInsomniaimpacts

Documenting the behavioral, emotional, andhealth consequences of insomnia is importantfor justifying the public health need forresearch on insomnia

Quality of life of insomnia19 Indefinite Fifty mixed-format items mainly focused ondomains of daily functioning. Translated into anumber of languages

Sleep effects index76 Past week Twenty-five five-point-scale items. Factors ofnon-clinical dysphoria, sleepiness/cognitiveinefficiency, motor impairment, and socialdiscomfort

Insomnia impact scale (IIS)17 Past 2 Weeks Forty five-point-scale Agree/Disagree itemsfocusing on insomnia-related distress symptoms

Sickness impact profile (SIP)77 Indefinite One hundred and thirty-six Yes/No items. Maindimensions of physical, psychosocial, andindependent categories. Categories ofambulation, mobility, body care andmovement, social interaction, alertness,behavior, emotional behavior, communication,sleep and rest, eating, work, homemanagement, recreation, and pastimes


D.E. Moul et al.188

Table 2 (continued)



SF-3620 Past month Thirty-six five-point-scale items. Indices forphysical function, role physical, role emotional,mental health, vitality, social, general health.Popular, but not designed specifically forinsomnia

Marchini monitoringinventory78

Now Twenty-one five-point-scale items. Reports ondaily activity rates

Leger’s Q2 questionnaire79 Indefinite Fifty-four Yes/No items written in French.Consequence domains include domesticaspects, physical fatigue, motivation,neurocognitive aspects, psychological fatigue,occupational, driving/accidents, leisure, familyrelations, and social relations

Arousal To move beyond the truism that arousalprevents sleep, ‘arousal’ will need to be definedin relation to something other than thelikelihood of sleeping. These questionnairesassess dimensions of arousal possibly relevantto insomnia research

Hyperarousal scale80 Indefinite Twenty-six four-point-scale items focusing orreactivity to events and stimuli

Arousability predispositionscale81

Indefinite Twelve five-point-scale frequency-based itemsfocusing on reactivity

Pre-sleep arousal scale82 Indefinite Fifteen five-point-scale items concerning pre-sleep experiences. Domains of cognitive andsomatic arousal

Activation-deactivationadjective checklist short form

Now Twenty four-point-scale items. Factors ofgeneral activation, high activation, generaldeactivation, deactivation-sleep from the ADACL long form83

The multidimensional angerinventory84

Indefinite Thirty-eight five-point-scale items. Factors ofanger arousal, range of anger-elicitingsituations, hostile outlook, anger-in, and anger-out

Fatigue Fatigue is a common, non-specific symptom ofinsomnia patients that needs more careful andprecise descriptions

Multidimensional fatigueinventory (MFI-20)85

‘Lately’ Twenty five-point-scale items. Subscales ofgeneral fatigue, physical fatigue, reducedactivity, reduced motivation, and mentalfatigue

Global vigor and affectinstrument86

Today Eight VAS items. Domains of global vigor, globalaffect

FACES87 Sixty-five four-point-scale items. Subscales forFaces, Anergy, Consciousness, Energized, andSleepiness

Sleepiness Some insomnia patients seem to feel sleepy, yetmay not be able to sleep or to nap. What theyreport when reporting sleepiness remainsunclear

Epworth sleepiness scale88 Past week Eight four-point-scale items rating the‘tendency to doze’ in particular situations.Available in French.47

Stanford sleepiness scale89 Now One item with seven ordinal categories. Thereis evidence it has separate, embedded factorsof activation and sleepiness. Available inFrench.47



design instruments that are properly tuned to theirtheories, and select instruments with appropriatevalidities suitable for answering their own theory-based research questions.

Theory-based instrumentation lives on the fron-tier of self-report questionnaires because theoriesplace greater demands on discriminating betweenpotential causal explanations. Improved testing of

Table 2 (continued)



The sleep–wake activityinventory90

Indefinite Fifty-nine VAS items. Factors of excessivedaytime sleepiness, psychic distress, socialdesirability, energy level, ability to relax, andnocturnal sleep. Intended as a sleepiness scale

Daytime sleepiness scale54 Past 2 Weeks Eight four-point-scale items: Fell asleep aspassenger, drowsy when still, asleep when withfriends, asleep during conversations, drowsydriving, sleepy after reading, and dosing whenrelaxed

Anxiety anddepression

Depression and anxiety are likely both causesand consequences of insomnia, but the causalsequences are not always clear, and therelationships may vary from person to person.Too many scales to mention here

Somaticfocus

Somatic symptoms may impair sleep.Estimating the degree of focus patients have onsomatic symptoms is important inunderstanding an insomnia complaint. (Painmetrics not included here)

Somatic symptom inventory91 Indefinite Twenty-six five-point-scale items about varioussomatic sensations

Extrinsic factorsStress andstrain

Stressful events and strains may precipitate ormaintain insomnia. Likewise, insomnia mayitself be a stress or strain. In either case, someassessment of stresses and strains is warranted

Impact of event scale92 Past week Fifteen four-point-scale items. Subscales ofintrusive thoughts and avoidance behaviors

Life events scale93 Past 6months

Ten Yes/No items about events: separations,deaths, illnesses, retirement, householdmoves, being a victim of crime, loss of driver’slicense, money problems. Designed for agingpopulations. One among many life eventschecklists available

Circadian Insomnia complaints often accompany irregularor non-standard sleep–wake activity patterns.Summary measures of these patterns may helpto place an insomnia complaint in context

Morning–eveningnessquestionnaire94

Indefinite Nineteen mixed-format items. Provides asummary score along the dimension ofmorningness-eveningness. Available in French[47: 2403]

Social rhythm metric36 Daily Fifteen time-reporting items about regular dailyactivities. Designed to quantify the overallregularity of activities

a This framework is provided only to generate convenience categories in the presentation of a heterogeneous collection ofquestionnaires.

b We attempted to format comments with as much consistency as possible. However, because of the heterogeneity of theinstruments, the formatting could not be entirely consistent without misrepresenting the unique qualities of the questionnaires.

c We use the term ‘subscales’ to refer to authors’ intentions to provide sub-metrics, ‘domain’ to refer to generalized themes in aquestionnaire, ‘factor’ to refer to results from factor analyses, and ‘report’ to refer to sleep parameters or more concretizedinformation.

D.E. Moul et al.190

theories must not only measure end-point dimen-sional outcomes, but also attempt to confirm ordisconfirm theoretical accounts of the series ofevents or phenomena occurring with poor sleepingand during various therapeutic transformations.Many current self-report instruments do not addressthis requirement for theory testing. On the otherhand, the psychologies of self-monitoring23 and ofself-interpretation24 raise methodological difficul-ties that may have special characteristics ininsomnia. Since the interface between distressand perceived insomnia remains a quandary,25

future theory-based questionnaire developmentcan be expected to take advantage of knowledgeadvancements regarding perceived insomnia dis-tress and its influences over other questionnaireresponses.

Results from studies that rigorously test processtheories in behavioral interventions will helpclinicians select and monitor interventions forvarious subtypes of insomnia patients. Havinggood process theories that clearly explain themechanisms of action of various interventions willenhance the intelligibility of interventions,increase their clinical specificity, and facilitatetheir export to everyday clinical settings.

Scenario #3: epidemiological, casecontrol, and genetic studies:observational studies

An ‘observational study’ generally refers to a study inwhich the investigator collects information largelywithout manipulating therapeutic or otherexposures: The researcher just ‘observes.’ Observa-tional studies fall into two general types. The firsttype of study focuses on population descriptions,ideally using samples drawn randomly from prob-ability-weighted population strata. The second kindof study focuses on analyzing available data to findrisk factors for a particular disease or disorder. Thesecond, analytic type of study can also use randomsamples,butoften formscomparatorgroupsbasedonoutcomes observed in convenience samples. Studiesthat sample on the basis of outcome are called case–control studies. Case–control studies are often usedby clinical researchers when they explore for differ-ences between insomnia patients and controls,because the diagnosis serves as the outcome andthe researcher is looking for potential risk factors.Genetic studies fall within the general class ofobservational studies as well. There is a wide varietyof observational study designs,26 so our generalizingabout them here should be taken as heuristic.

What is the general kind of question that isasked in studies of epidemiological or case–controlstudies of insomnia in populations? The main aim ofmany epidemiological studies is to characterize thepattern of disease or disorder in the targetpopulation. Classifying people accurately is oftenmore important than scaling a latent construct. Forgood epidemiological studies, high diagnostic speci-ficity is usually a high priority. Yet in a number ofpreliminary studies, insomnia prevalence was esti-mated from answers to inadequate questions like‘Do you have insomnia?’ without defining insomniaas a condition. In those preliminary studies,respondents that endorsed having insomnia wereperforce required to use their own definitions,which is exactly contrary to the goal of accurateclassification of cases. In good epidemiologicalwork, much attention is focused on the definitionof diseases or disordered functioning, the nature ofthe population studied, potential sampling biases,and potential measurement problems.

What are the measurement priorities in observa-tional studies on insomnia? If the study is focused onmeasuring general disability in the population, then ahigh priority attribute for instrument selection is highsensitivity. This means that the instrument identifiesas many persons as possible who have the disease orcondition. General disability questions are asked byinvestigators planning medical services or formulat-ing government policies, tasks where it is moreimportant to know what medical service demands apopulation may make than it is to know exactly whattheir medical conditions are.

Yet for most epidemiological studies, andespecially for case–control studies, the diagnosticspecificity of an instrument is an especially highpriority because these studies usually focus on oneor more specific diseases or disorders. Case defi-nitions of insomnia vary considerably acrossstudies, yet case definitions are the core of thesestudy designs. For example, an epidemiologicallyuseful insomnia instrument should differentiatedepression-related insomnias from psychophysiolo-gic or primary insomnias. In these circumstances,sensitivity has some importance, since there is aseverity spectrum of insomnia in the population,but it is not the main priority if unambiguous risk-factor analysis is attempted. To guard againstconfounding, the measurement of co-morbiditiesand independent risk factors are additional highpriorities in analytic epidemiological studies,especially in longitudinal and case–control studies.

Less important attributes are continuous measure-ment scaling, transparency of scoring, multidimen-sional scaling, and detailed reviews of symptoms thatare not directly linked to the syndromal definition(s).


Low priority attributes for epidemiological studiesare psychological construct validities, theory-depen-dence, or treatment responsivity.

What practical constraints should be weighed inselecting an instrument for a epidemiological study?In epidemiological studies, a study’s quality hinges ongetting a large sample size in order to obtainprevalence or incidence estimates with narrowconfidence intervals and on minimizing potentialnon-response bias. It is better if the instrument orinterview can be easily completed by respondentsfrom a wide range of backgrounds and with aminimum of ambiguity and bias. Question wording,hierarchy, and ordering are critical for a study’sknowledge value, so much so that pretestingthe questionnaire may be mandatory. Usingbranching question structures that drop non-pro-ductive lines of questioning may improve the instru-ment’s performance by reducing its usual length, butruns the risk of respondents using ‘no’ answers toshorten the data collection process. In some circum-stances, use of a computer-assisted phone interview(CAPI) may be best, but this may be a problem if thesample population does not have a phone, or does notanswer phone requests. Pretesting the interviewshould also address recall biases. In field studies,training and paying interviewers, photocopyingforms, and managing data quality impose substantialcosts. In circumstances where the insomniaresearcher is inserting substudy questions into alarger epidemiological study, the overall adminis-trative fit between the instrument and the otherinstruments used in the study should be assessed.

Will one or more instruments suffice for obser-vational studies, or is there a need for betterinstruments? Early innovators in the epidemiologyof insomnia were Balter et al.,27 who constructedan interview from questions on the Hopkins Symp-tom Checklist-90. This approach probably favoredsensitivity, but did not instrument psychiatricsyndromes very well, which are major confoundsof primary insomnia diagnoses. Some investi-gators18 have devised short question sequencesdesigned to gain estimates of insomnia prevalence,without regard to diagnosis. Short questionsequences may overlook relevant nighttime ordaytime symptoms, so present some risk of missedfindings. Such approaches may be more useful forservices planning or policy formulation.

By contrast, Ford and Kamerow,28 utilizing datafrom the Diagnostic Interview Schedule (DIS), alsoprovided some prevalence estimates from theEpidemiologic Catchment Area Study but inreference to formally modeled psychiatric diag-noses. The DIS is a structured interview given torespondents by trained interviewers, written to

estimate diagnoses from the DSM of the AmericanPsychiatric Association.3 The DIS and the Compo-site International Diagnostic Interview (CIDI)29 (itshistorical descendant) are a reasonably goodinstruments to use where direct interviewing ispossible. However, the DIS was not designed withinsomnia as its central focus, so nocturnalsymptoms are not explored in depth in the DISor CIDI. In recent years, Ohayon30 has developed acomputer-assisted interview (SLEEP-EVAL) thatcan be used to estimate prevalence not only ofprimary insomnia, but also of other confoundingconditions. It can provide research diagnosticclassifications based both on the DSM system,and with the ICSD.2 The SLEEP-EVAL interview alsooffers the advantage of distinguishing betweensleep dissatisfaction and a clear insomnia com-plaint. Its disadvantage is that it, like the DIS,does not query nocturnal symptoms in depth. Formore clinically based studies, the StructuredClinical Interview for DSM-IV Axis I Disorders31 isa well-regarded interview that reviews psychiatricdiagnoses systematically (but not sleep disorders).More recently, Schramm et al.32 have developedthe Structured Interview for DSM-III-R sleepdisorders, although symptoms are not exploredin detail. These latter two interviews are clinicallybased.

Because sleeping pill use is often a topic ofsome public concern, epidemiological studies ofinsomnia often are concerned with the estimationof sleeping pill use. Pharmacoepidemiologicalcomponents to such studies add significantly to astudy’s design complexity. Since benzodiazepinemedications can be used as both hypnotics andanxiolytics, disentangling whether prescriptionswere given appropriately involves not only deter-mining what medication was actually prescribedand how it was consumed, but also whether themedication was actually prescribed uniquely as ahypnotic for ‘pure’ insomnia. The latter methodo-logical problem, called confounding by indication,is a very common problem in pharmacoepidemio-logical studies.33 Simply measuring pill usage islargely uninformative, so studies investigatingthe appropriateness of prescribing and userequire careful methodological fits betweenthe epidemiologies of the insomnias and mentalhealth with the epidemiologies of psychotropicuse. The best methods for determining pill useinvolve the use of color photographic displays ofpills or actual inspections of home medicine cabi-nets. Actually taking blood levels or doing daily pillcounts is impossible in epidemiological studies. Insome cases, likelihood-of-indication markers arepostulated from dose/frequency relationships

D.E. Moul et al.192

(e.g. trazodone 50 mg qhs), which may be a usefulstrategy, but might not address use for insomniaversus for nightmares. Since both determining themedications taken and the indications for useinvolve possible faults of memory in the respon-dents, special methodological difficulties awaitresearchers who desire to understand whetherhypnotics are prescribed appropriately for insom-nia, and whether such prescribing is safe andeffective.

Epidemiological studies largely depend upondefinitions of disease or disorder. With this inmind, the SLEEP-EVAL, or perhaps the CIDI, maybe regarded as acceptable instruments for epide-miological studies if interviewers can be used.This is the usual context in which epidemiologicalstudies are conducted, owing to the need tomanage the sampling protocols. These interviewsoffer some measures of competing causes ofinsomnia other than primary insomnia. Advance-ments in knowledge about insomnia are now likelyto require improvements in such instrumentstailored to answer specific questions about riskfactors for or consequences of insomnia. Forservices research studies, Jenkins’ questionnairemay provide good information with a minimum ofsubject burden. Given the public concern aboutwhether sleeping pill use is appropriate or not,pharmacoepidemiological instrumentation willcontinue to be an enduring methodological chal-lenge. Currently, there are no standardizedinstruments available for pharmacoepidemiologi-cal studies of hypnotics.

Scenario #4: geriatric insomnia

What is the general kind of question that is askedin studies of geriatric insomnia? The heterogeneityin health statuses in aging populations makes itunlikely that there is one general kind of question.Even by itself, normal aging reduces slow-wavesleep, increases the number of awakenings, light-ens sleep, and possibly reduces the homoeostaticdrive for sleep. Extrinsically, retirement from workgenerally results in fewer daily scheduled events,which may also influence the timing of sleep andnapping. Many aged persons also develop healthconditions too numerous to list here. Furthermore,not all retirements are financially or sociallysecure. The elderly renegotiate their philosophiesof daily activities and sleeping (e.g. of napping)across a range of opportunities and constraints.Physical disabilities, disabilities in spouses, wor-ries, cognitive brittleness, reduced coping skills,

and monotonous daily routines all may facilitatedifficulties with sleeping. Medication use oftensustains one’s independence, and use of hypnoticsmay be more acceptable thanearlier in life. Strokeordementia may further injure a person’s ability toregulate one’s sleep–wake schedule, and lead toinstitutionalization. These and other considerationsimply that the study designs used in aging studies arelikely to require a careful subgroup focus and/or greatcare in selecting instruments to measure confoundingvariables.

What are the measurement priorities in agingstudies on insomnia? Specificity in measuring healthconditions is an obvious high priority. An additionalhigh priority is the specification of cognitive level,both as a health correlate, but also as cognitiveimpairment may affect self-reporting. For a symp-tom such as insomnia, the measurement issues arelikely to resemble those observed in geriatricdepression, as follows. In the Epidemiologic Catch-ment Area Study, data from the DIS supported theconclusion that depression was not a highly preva-lent problem in the aged; however, a separatestudy in a large substudy using the Present StateExamination suggested otherwise.34 Evidently, theway DIS wording and criteria were organized did notreflect how the elderly themselves might reportpoor mood functioning. Due to cohort biases orcognitive changes, the elderly may report symp-toms of demoralization, depression, or insomnia indifferent ways from younger populations. Thus, it isimportant that the selected instrument(s) usedreflect how the elderly subpopulation thinks aboutits sleep and other life difficulties.

What practical constraints should be weighed inselecting an instrument for study among theaging? One clear difficulty is whether to approachthe measurement of insomnia more in a categori-cal sense, or in a dimensional sense. The potentialvalue of conceptualizing insomnia diagnostically isthat criteria can be stipulated across subpopu-lations. This diagnostic approach is more appro-priate for case –control studies, where starkcontrasts are desired. Yet the dimensionalapproach may guide instrumenting chronic insom-nia more meaningfully. It will be even moredifficult to place 80-year-olds into diagnosticsubtypes of insomnia than it is to classify 20-year-old insomniacs into such archetypes. Investi-gators cannot ignore the implications of choosingbetween these approaches. In addition, minimizingrespondent burden by selecting shorter instru-ments with simply worded items may providebetter information across the aged study sample.When investigators need face-to-face interviews,the interviewers should have the skills for working


with the selected aging subpopulation(s). Usingskilled interviewers is a trade-off against rotestandardization, since the interviewersmay introducebiases by virtue of their expertise or prior experience.

Will one or more instruments suffice forinsomnia studies in the aging, or is there a needfor better instruments? The shallower and morefragmented sleep of normal aging poses interest-ing challenges for investigators in differentiatingnormal sleep from sleep that is dissatisfying to theperson but not a medical complaint, and fromsleep that generates a complaint but no obviousPSG abnormality. The SLEEP-EVAL examination byOhayon appears to approach this question to someextent in epidemiological studies, but it is notclear that the SLEEP-EVAL exam is fully ready foraging population studies. At more clinical levels,Fichten and colleagues have approached thequestion of instrumenting sleep distress in theaged with the Sleep Behaviors 60 þ Question-naire35 in concert with an ensemble of othermeasures. The work of Morin and colleagues haslikewise established the suitability of the SII instudies of aging insomnia patients. Monk’s SocialRhythm Metric36 must be regarded as especiallyrelevant in examining the circadian stability of thedaily regimens of aging persons. While not ‘insomnia’in the usual senseof the term, the extremely light andfragmented sleep of demented elderly patient alsorequires evaluation from the standpoint of the elder’scaregiver. Clearly, some investigators have begunuseful lines of inquiry regarding insomnia in theelderly, but sleep research on the aging will continueto need specially adapted questionnaires (1) tounderstand elderly subjects’ beliefs and experiencesof sleeping and activity regulation, and (2) to assistwith identifying and assessing patterns of poorsleeping as they may affect health outcome andsocial independence.

Questionnaire development needsfor the insomnia field

Insomnia research at this time probably is in asimilar situation to psychiatric research in the 19thcentury in that even the definitions of the termsemployed remains open to debate. Resolution ofsuch debates will depend partly on review of dataprovided by self-report questionnaires, as designedfor different populations and from differing theoreti-cal perspectives. Thus, progress in insomnia researchwill depend in part upon advancements in question-naire design. From this review, several needs forquestionnaire development can be identified:

1. Past-week insomnia rating scale integratingdaytime and nighttime distress, subjectivesleep parameters, and quality of life domainsfor use in outcome-based studies.

2. An instrument for thekindof subjective sleepinessthat insomnia sufferers endorse (i.e. feelingsleepy, but being unable to sleep or nap). Suchan instrument may require careful empiricalstudies of ‘sleepiness’ semantics among chronicinsomnia patients.

3. Improved instruments for tracking stimulus con-trol and cognitive behavior therapy interventionsin the in-bed time domain.

4. Instruments to clarify kinds of arousal betweengeneral activation, deactivation, generalizedanxiety, sleep anxiety, general worry, sleepworry, non-pathological worry, somatic acti-vation, paradoxical fatigued alertness, and‘pure’ alertness at bedtime.

5. Improved screening instruments for use in pri-mary care, designed to assist in triaging insomniacomplaints between depressive, anxiety, medi-cal, and primary insomnia disorders.

6. Instrumentation for understanding how insomniapatients decide between treatments that may beoffered, especially in the framework of relativeutility and cost-benefit thinking.

7. Improved techniques for experience samplinginsomnia patients during the daytime.

8. Improved longitudinal instruments to track thecourse of insomnia, with ability to detect period-icities of episodes. Such instruments could beespecially useful if they enabled the distinctionbetween qualitative classes of sleep: good sleep,adequate sleep, dissatisfying but tolerable sleep,sleep that causes a medical complaint, andinsomnia that causes substantial daytime distressor disability.

9. Since so many studies rely on case–controlmethodology, there is a great need for thedevelopment of diagnostic questionnaires andinterview schedules that can select kinds ofinsomnia with high grades of definitional speci-ficity. Without this, finding risk factors fordifferent kinds of insomnia will be much moredifficult.

10. Better instruments to place insomnia in thecontext of multiple medical comorbidities.

11. Improved methods to query hypnotic medicationuse in populations, in both primary and secondarydata sources, with specialized techniques toaccount for confounding by indication.

12. Since insomnia is a risk factor for institutionalplacement of demented persons living inthe community, caregiver-based questionnairesdesigned to identify poor sleeping in demented

D.E. Moul et al.194

persons may assist in targeting caregivers for cost-effective interventions.

Conclusion

Designing studies about insomnia in adult popu-lations begins with the problem of the definitionof insomnia itself. Even after an investigatordecides what definition to select for a study, heor she must still consider carefully what self-report measures to use. The process of selectingan ensemble of questionnaires wisely begins withconsideration of factors that include the popu-lation sampled, the kind of study anticipated, andthe theory of insomnia that is modeled. Wherereasonable, there are significant scientific benefitsfrom using questionnaires that others have devel-oped and/or characterized. However, whether aninvestigator is using a well established question-naire or inventing a new one, it remains his or herresponsibility to consider the reliability andvalidities of the questionnaires used if the studyis to contribute to the advancement of knowledgeabout insomnia.

Acknowledgements

The authors thank David Kupfer, M.D., Ronald Dahl,M.D. and Anne Germain, Ph.D. for helpful sugges-tions. This work was supported by grants AG15138,AG00972, MH30915, MH16804 and MH01554. Theauthors also thank the peer reviewers of this articlefor helpful suggestions.

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Practice points

† While insomnia is a common problem withdiverse causes, its consequences spannighttime distress, sleep parameters (e.g.sleep latency, hours of sleep), daytimedistress, functional impairments, anddecreased quality of life.

† A variety of insomnia-related instrumentsare available for use in clinical settings.Selecting the ‘best’ questionnaire for aparticular clinical practice context involvesconsidering carefully how the questionnairewill exactly help screen, diagnose, ormonitor the specific clinical populationserved.

† Great caution is needed when interpretingepidemiological studies of sleeping pill use,whether they report in favor or against suchuse. Such studies usually cannot properlyaddress the reasons and contexts in whichprescribing was actually undertaken.

Research agenda

General goals include:† Validation of insomnia as a unique syndrome

through identification of potentialbiomarkers that may be correlated withinsomnia self-report data.

† Integrated and consensus-based multi-domain descriptions of insomnia, collectedprospectively and with various time-framesof self-reports.

† Development of improved instruments foruse in clinical trials, theory tests,observational studies, and aging studies.

* The most important references are denoted by asterisk.


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