1、 Behavioral and psychological treatments for chronic insomnia disorder in adults:an American Academy of Sleep Medicine clinical practice guideline Jack D.Edinger,PhD1;J.Todd Arnedt,PhD2;Suzanne M.Bertisch,MD,MPH3;Colleen E.Carney,PhD 4;John J.Harrington,MD5;Kenneth L.Lichstein,PhD6;Michael J.Sateia,
2、MD,FAASM7;Wendy M.Troxel,PhD8;Eric S.Zhou,PhD9;Uzma Kazmi,MPH10;Jonathan L.Heald,MA10;Jennifer L.Martin,PhD11,12 1National Jewish Health,Denver,CO 2University of Michigan,Ann Arbor,MI 3Brigham and Womens Hospital,Harvard Medical School,Boston,MA 4Ryerson University,Toronto,CA 5University of Nebraska
3、 Medical Center,Omaha,NE 6University of Alabama,Tuscaloosa,AL 7Geisel School of Medicine at Dartmouth,Hanover,NH 8RAND Corporation,Pittsburgh,PA 9Harvard Medical School,Dana-Farber Cancer Institute,Boston Childrens Hospital,Boston,MA 10American Academy of Sleep Medicine,Darien,IL 11David Geffen Scho
4、ol of Medicine at the University of California Los Angeles,Los Angeles,CA 12VA Greater Los Angeles Healthcare System,Geriatric Research,Education and Clinical Center,Los Angeles,CA Address correspondence to:Jack D.Edinger,PhD,National Jewish Health,1400 Jackson St,Denver,CO 80206;Email:EdingerJNJHea
5、lth.org ManuscriptDownloaded from jcsm.aasm.org by 36.112.171.122 on November 11,2020.For personal use only.No other uses without permission.Copyright 2020 American Academy of Sleep Medicine.All rights reserved.ABSTRACT Introduction:This guideline establishes clinical practice recommendations for th
6、e use of behavioral and psychological treatments for chronic insomnia disorder in adults.Methods:The American Academy of Sleep Medicine(AASM)commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an as
7、sessment of the evidence using Grading of Recommendations Assessment,Development and Evaluation(GRADE)methodology.The task force evaluated a summary of the relevant literature and the quality of evidence,the balance of clinically relevant benefits and harms,patient values and preferences,and resourc
8、e use considerations that underpin the recommendations.The AASM Board of Directors approved the final recommendations.Recommendations:The following recommendations are intended as a guide for clinicians in choosing a specific behavioral and psychological therapy for the treatment of chronic insomnia
9、 disorder in adult patients.Each recommendation statement is assigned a strength(“strong”or“conditional”).A“strong”recommendation(ie,“We recommend”)is one that clinicians should follow under most circumstances.A“conditional”recommendation is one that requires that the clinician use clinical knowledg
10、e and experience,and to strongly consider the patients values and preferences to determine the best course of action.1.We recommend that clinicians use multi-component cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults.(STRONG)2.We suggest that clinici
11、ans use multi-component brief therapies for insomnia for the treatment of chronic insomnia disorder in adults.(CONDITIONAL)3.We suggest that clinicians use stimulus control as a single-component therapy for the treatment of chronic insomnia disorder in adults.(CONDITIONAL)4.We suggest that clinician
12、s use sleep restriction therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults.(CONDITIONAL)5.We suggest that clinicians use relaxation therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults.(CONDITIONAL)6.We suggest tha
13、t clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults.(CONDITIONAL)Downloaded from jcsm.aasm.org by 36.112.171.122 on November 11,2020.For personal use only.No other uses without permission.Copyright 2020 American Academy of Sleep M
14、edicine.All rights reserved.INTRODUCTION Chronic insomnia disorder is a common sleep disorder that leads to impairment in health and functioning 1,2.This clinical practice guideline is intended to update the previously published American Academy of Sleep Medicine(AASM)guidelines on the psychological
15、 and behavioral treatments of insomnia.3 This guideline,in conjunction with the accompanying systematic review(SR)4,provides a comprehensive update of the available evidence and a synthesis of clinical practice recommendations for the psychological and behavioral treatments of chronic insomnia disor
16、der.It is intended to optimize patient-centered care by providing actionable recommendations for the use of specific behavioral and psychological treatments in adults with chronic insomnia disorder.Separate clinical practice guidelines for pharmacologic treatment of chronic insomnia disorder are ava
17、ilable.5 The treatment of chronic insomnia disorder should be based on a diagnosis established using ICSD-3 or DSM-5 criteria,6,7 and a comprehensive clinical history.Historically,in some settings patients have been offered only sleep hygiene as treatment for their chronic insomnia disorder;however,
18、standard of care should be to provide one of the recommended interventions discussed within the guideline to patients with chronic insomnia disorder,taking into consideration the accessibility and resource requirements when deciding on the most appropriate treatment for a given patient.Follow-up car
19、e to evaluate symptoms at the conclusion of treatment is indicated,and residual sleep-related symptoms should be evaluated and addressed.METHODS The AASM commissioned a task force(TF)of sleep medicine clinicians with expertise in chronic insomnia disorder.The TF was required to disclose all potentia
20、l conflicts of interest(COI),per the AASMs COI policy,prior to being appointed to the TF and throughout the research and writing of the guideline and SR documents.In accordance with the AASMs conflicts of interest policy,individuals were not appointed to the TF if they reported a professional or fin
21、ancial conflict that might diminish the integrity,credibility or ethical standards of the guideline.Individuals reporting professional or financial conflicts that represented potential bias but did not prohibit participation in the development of the guideline,were required to recuse themselves from
22、 discussion or writing responsibilities related to the conflicts.All relevant conflicts of interest reported by the TF are listed in the Disclosures section.The TF conducted a SR of the published scientific literature,4 to answer two Patient,Intervention,Comparison,and Outcomes(PICO)questions relate
23、d to the behavioral and psychological treatments for insomnia in adults.The review focused exclusively on efficacy of behavioral and psychological interventions of chronic insomnia disorder in adults,with and without comorbid conditions(Table 1),compared to control or minimal intervention(PICO 1).Th
24、e review also compared the effectiveness of different intervention delivery methods(eg,individual,group,telehealth,internet-based programs,telephone;PICO 2).The SR focused on the following critical patient-oriented,clinically relevant outcomes:patient reported sleep quality,sleep latency,wake after
25、sleep onset and remission and responder rates.The TF considered remission and responder rates as the most influential critical outcomes for evaluating the quality of evidence.The review did not conduct comparisons of different interventions or combinations of pharmacotherapy with behavioral and psyc
26、hological therapy.These clinical practice recommendations were then developed according to the Grading of Recommendations Assessment,Development and Evaluation(GRADE)process 8,9,based on the literature that provided data suitable for statistical analyses of the critical outcomes.The TF assessed the
27、following four factors to determine the direction and strength of a recommendation:quality of evidence,balance of beneficial and harmful effects,patient values and preferences,and resource use.Details of these assessments can be found in the accompanying systematic review.Taking these major factors
28、into consideration,each recommendation statement was assigned a strength(“strong”or“conditional”).When deemed necessary by the TF,additional information is provided in the form of“remarks”immediately following the recommendation statements.Remarks are based on the evidence evaluated during the syste
29、matic review and are intended to provide context for the recommendations and to guide clinicians in the implementation of the recommendations in daily practice.Downloaded from jcsm.aasm.org by 36.112.171.122 on November 11,2020.For personal use only.No other uses without permission.Copyright 2020 Am
30、erican Academy of Sleep Medicine.All rights reserved.The recommendations in this guideline define interventions that should meet the needs of most patients in most situations.A“strong”recommendation is one that clinicians should follow for almost all patients(ie,something that might qualify as a qua
31、lity measure).A“conditional”recommendation reflects a lower degree of certainty in the appropriateness of the patient-care strategy for all patients(Table 2 shows the implications of recommendation strength).It requires that the clinician use clinical knowledge and experience,and strongly considers
32、the individual patients values and preferences to determine the best course of action.The ultimate judgment regarding any specific care must be made by the treating clinician and the patient,taking into consideration the individual circumstances of the patient,available treatment options,and resourc
33、es.The AASM expects this guideline to have an impact on professional behavior,patient outcomes,andpossiblyhealth care costs.This clinical practice guideline reflects the state of knowledge at the time of publication and will be reviewed and updated as new information becomes available.RECOMMENDATION
34、S The following clinical practice recommendations are based on a systematic review and evaluation of evidence using the GRADE process.The implications of the strength of recommendations for guideline users are summarized in Table 2 and the recommendations for interventions are summarized in Table 3.
35、Remarks are provided as context for the recommendations and to guide clinicians in the implementation of these recommendations.There was insufficient evidence to make recommendations for specific delivery methods(eg,individual,group,internet,self-help,video)for any of the treatments.For all treatmen
36、ts except for cognitive behavioral therapy for insomnia(CBT-I),there was insufficient data to evaluate efficacy within patient subgroups(ie,with or without comorbidities).In addition,there were fewer than three studies meeting our inclusion criteria for the use of cognitive therapy,paradoxical inten
37、tion,mindfulness,biofeedback and intensive sleep retraining;as a result,no recommendations are made about these treatments.A detailed review of the data for all interventions can be found in the accompanying systematic review.Cognitive behavioral therapy for insomnia Recommendation 1:We recommend th
38、at clinicians use multi-component cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults.(STRONG)Remarks:This recommendation is based primarily on studies in which CBT-I was delivered by a trained professional to patients with and without comorbid conditio
39、ns.The TF made a strong recommendation in favor of CBT-I based on a large body of moderate quality evidence from 49 studies,including multiple,recent,large RCTs,showing clinically meaningful improvements in critical outcomes,patients highly preferring behavioral and psychological treatments,and favo
40、rable information on cost-effectiveness of CBT-I.The TF assessed whether CBT-I improved patient-reported critical outcomes:remission rate,responder rate,sleep quality,sleep latency and wake after sleep onset.The TF identified 66 randomized controlled trials(RCTs)in adult patients diagnosed with chro
41、nic insomnia disorder that compared CBT-I to wait-list,minimal interventions,or placebo therapies.Forty-nine of the studies provided data suitable for meta-analyses for at least one critical outcome.Meta-analyses demonstrated clinically significant improvements in remission and responder rates with
42、CBT-I compared to control conditions.Of these 49 studies,11 studies included patients with insomnia and no comorbidities,six studies included patients with insomnia and comorbid psychiatric conditions and 12 studies included patients with insomnia and comorbid medical conditions.Each of these patien
43、t groups was analyzed separately.Twenty studies included a mix of patients with and without comorbidities and were not separately analyzed.Meta-analyses of sleep quality demonstrated clinically significant mean improvements in Downloaded from jcsm.aasm.org by 36.112.171.122 on November 11,2020.For p
44、ersonal use only.No other uses without permission.Copyright 2020 American Academy of Sleep Medicine.All rights reserved.patients with insomnia and no comorbidities and patients with insomnia and comorbid psychiatric conditions.Meta-analyses of sleep latency and wake after sleep onset demonstrated cl
45、inically significant mean improvements in patients with insomnia and comorbid psychiatric conditions and in patients with insomnia and no comorbidities.Meta-analyses of remission and responder rates were clinically significant for all three subgroups.The overall quality of evidence was moderate due
46、to imprecision.The quality of evidence was moderate for sleep latency,remission and responder rates.Benefits of CBT-I include treatment gains that are potentially durable over the long term without the need for additional interventions.CBT-I may reduce the need for pharmacologic therapy and thereby
47、reduce patient risk of drug-related adverse events.The principal harms associated with CBT-I are symptoms of daytime fatigue and sleepiness,mood impairment(eg,irritability),and cognitive difficulties(eg,attention problems)during treatment;however,these undesirable effects are primarily restricted to
48、 the early stages of treatment,when behavioral therapies are introduced,and improve over time,typically resolving by the end of treatment.Based on clinical experience,the TF determined that the benefits of CBT-I strongly outweighed the short-term undesirable effects for adults with chronic insomnia
49、disorder.Clinicians should also note that when sleep restriction therapy is used as a component of CBT-I,this treatment may be contraindicated in certain populations such as those working in high risk occupations(eg,heavy machinery operators or drivers)or those predisposed to mania/hypomania or with
50、 poorly controlled seizure disorders.While cost of treatment varies by delivery method,the cost-effectiveness of CBT-I is favorable,as CBT-I is a time-limited treatment,and the limited available data suggests significant costs of untreated chronic insomnia disorder.The clinical consensus of the task