Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians
Venue: Annals of Internal Medicine

Sleep difficulties, including the inability to initiate or maintain sleep, are common in adults. Sleep difficulties are typically transient; however, when they become chronic and cause distress or daytime dysfunction, insomnia disorder may be present. The American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, defines insomnia disorder as a predominant symptom of difficulty with sleep initiation, difficulty maintaining sleep, or early morning waking with inability to return to sleep causing clinically significant distress or impairment in activities, occurring at least 3 nights per week for 3 months or more (1) Furthermore, individuals must have adequate opportunity for sleep and the symptoms cannot be better explained by medical or mental conditions, including another sleep disorder (such as breathing related sleep disorder) or medication or substance use. The term previously used for insomnia disorder is chronic insomnia (14) for which diagnostic criteria required sleep problems lasting from weeks to months. These criteria are empirically similar to current criteria for insomnia disorder. We use the term insomnia disorder even though much of the primary research has used other terminology (such as chronic insomnia and persistent insomnia) Between 6% and 10% of adults meet the diagnostic criteria for insomnia disorder (4) Duration ranges from 1 to 20 years across longitudinal studies (5) Insomnia disorder is more common in female patients and older adults (6, 7) Older adults typically report difficulty maintaining sleep as opposed to initiating sleep, which is common in younger adults (8) Many treatment types are available once insomnia disorder is accurately diagnosed by using established diagnostic criteria (4, 9) These include psychological and behavioral treatments, pharmacologic therapies, and complementary and alternative medicine. The American Academy of Sleep Medicine recommends psychological and behavioral interventions and supports short term supplementary medication (9, 10) Psychological and behavioral interventions include cognitive behavioral therapy for insomnia (CBT I) multicomponent behavioral therapy (brief behavioral therapy for insomnia) and single component interventions (such as sleep hygiene and education, stimulus control, sleep restriction, and relaxation) (Table) Cognitive behavioral therapy for insomnia most commonly includes behavioral therapies (sleep restriction, stimulus control, relaxation training) cognitive therapy (cognitive restructuring) to change dysfunctional beliefs about sleep, as well as sleep hygiene education (3) Multicomponent behavioral therapies combine several behavioral therapies and do not include a cognitive component. Table. Psychological and Behavioral Interventions for Insomnia Disorder* Treatment goals include improving quality and quantity of sleep and associated impairments (10) Ideally, meaningful improvements in global outcomes measuring sleep and associated distress and dysfunction are realized. The Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index (PSQI) are commonly used for measuring global outcomes. Sleep outcomes include specific sleep variables (sleep onset latency [SOL] wake time after sleep onset [WASO] total sleep time [TST] sleep efficiency (sleep time/time in bed) and sleep quality. Sleep variables can be measured objectively (with polysomnography or actigraphy) or subjectively (sleep diaries) Guidelines suggest monitoring symptoms with sleep diaries and polysomography is not indicated (10) We conducted a systematic review on the management of insomnia disorder for the Agency for Healthcare Research and Quality (11) This article reports evidence on psychological and behavioral interventions. Another article reports on the evidence on pharmacologic interventions and the comparison of pharmacologic interventions with psychological and behavioral interventions (12) and the full report provides evidence on complementary and alternative interventions. This evidence was used by the American College of Physicians to develop the guideline on the treatment of insomnia disorder in primary care. Evidence summarized here enhances previous reports (1315) by providing a comprehensive evaluation of psychological and behavioral interventions across all delivery modes with a primary emphasis on global outcomes.  Data Sources and Searches We searched bibliographic databases, including MEDLINE, Embase, and PsycINFO via Ovid, as well as the Cochrane Library, to identify randomized, controlled trials published from 2004 through September 2015 (Supplement) We identified studies published before 2004 by searching the citations in relevant systematic reviews.  Two investigators independently reviewed titles and abstracts of search results to identify potentially eligible references. Two investigators independently screened full texts of those references to determine whether inclusion criteria were met. We included randomized, controlled trials of psychological and behavioral interventions if they enrolled adults, provided at least 4 weeks of treatment, reported global or sleep outcomes, and were published in English. We excluded trials enrolling pure subgroups of patients with major medical conditions or conditions that may explain the sleep problems (such as menopause, pregnancy, and neurologic conditions) Data Extraction and Quality Assessment Risk of bias was independently assessed by two investigators using an instrument developed using Agency for Healthcare Research and Quality guidance (16) and was summarized as low, medium, or high on the basis of summary risk of bias and confidence that results were believable given limitations. Study, participant, and treatment characteristics; outcomes; and adverse events were extracted from eligible trials with low or moderate risk of bias.  We used RevMan 5.2 (Nordic Cochrane Center) for pooling when adequate data were provided and populations, interventions, and outcomes were similar (17) DerSimonian and Laird random effects estimates of risk ratios and absolute risk differences with 95% CIs were calculated for categorical outcomes, and weighted mean differences (WMDs) and/or standardized mean differences with 95% CIs were calculated for continuous outcomes. We assessed heterogeneity with the Cochran Q test and I 2 statistic (75% indicates substantial heterogeneity) (18) We analyzed the general adult population and older adults separately because sleep measures vary. We used established minimum important differences (MIDs) to capture clinical significance in global outcomes. The MID for the ISI is a 6 point change from baseline (19) Trials that conducted remitter or responder analysis on the basis of established MID offer simplistic interpretation. When trials provided mean scores, we interpreted WMDs in relation to MID by using the method of Johnson and colleagues (20) Weighted mean differences equal to or greater than the MID suggest that many patients gain important benefits, WMDs greater than half the MID but less than the MID suggest that an appreciable number of patients benefit, and WMDs less than half of the MID suggest that patients do not achieve important benefits (20) One investigator assessed strength of evidence for unique comparisons as high, moderate, low, or insufficient (21) assessments were confirmed through consensus. Role of Funding Source This topic was nominated to and funded by the Agency for Healthcare Research and Quality Effective Health Care Program. Key informants representing various perspectives offered suggestions as refined the review scope. Our draft protocol was shared with a technical expert panel that had the opportunity to review the draft report. The American College of Physicians provided support for this manuscript preparation. The authors are solely responsible for its contents.  We identified 3572 citations; 559 required full text review after title and abstract screening ( Seventy six articles (2297) reporting on 70 trials that compared psychological and behavioral interventions with inactive controls or other psychological and behavioral interventions were eligible. We extracted data and analyzed results for 60 trials with low to moderate risk of bias. We grouped trials by intervention type and comparison. Interventions for CBT I had cognitive and behavioral components; multicomponent behavioral therapy interventions had several behavioral components and no cognitive component; and single component interventions included sleep restriction, stimulus control, and relaxation.  Intervention type totals do not equal total references because several trials were used in the analysis for 2 different types of interventions. RCT randomized, controlled trial. Eligible trials (Tables 1 and 2 of the Supplement) enrolled individuals most commonly diagnosed with chronic insomnia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with mean durations of several years. Participants were predominantly female and white. Trials were conducted in the United States, Canada, the United Kingdom, Sweden, Australia, Norway, Scotland, the Netherlands, and China. Mean age was mid 40s in general adult populations and lower 70s in older adults. Baseline ISI scores were approximately 17, indicating moderate severity, and baseline SOL was more than 45 minutes. Comparisons varied across trials. Inactive controls included information (such as sleep hygiene education) or waitlist; trials infrequently used sham treatments. Adverse effects were rarely reported. Withdrawals were not always reported by group. Evidence on adverse effects and withdrawals was insufficient for all comparisons. We assessed strength of