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Introduction: This guideline establishes clinical practice recommendations for the 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 and sleep psychology to develop recommendations and assign strengths based on a systematic review of the literature and an assessment 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 resource 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 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 knowledge and experience, and to strongly consider the patient’s values and preferences to determine the best course of action. We recommend that clinicians use multicomponent cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults. (STRONG) We suggest that clinicians use multicomponent brief therapies for insomnia for the treatment of chronic insomnia disorder in adults. (CONDITIONAL) We suggest that clinicians use stimulus control as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL) We suggest that clinicians use sleep restriction therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL) We suggest that clinicians use relaxation therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL) We suggest that clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL) Citation: Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med . 2021;17(2):255–262.

Introduction: The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for chronic insomnia disorder in adult populations. Methods: The American Academy of Sleep Medicine commissioned a task force of 9 experts in sleep medicine and sleep psychology. A systematic review was conducted to identify randomized controlled trials that addressed behavioral and psychological interventions for the treatment of chronic insomnia disorder in adults. Statistical analyses were performed to determine if the treatments produced clinically significant improvements in a range of critical and important outcomes. Finally, the Grading of Recommendations Assessment, Development, and Evaluation process was used to evaluate the evidence for making specific treatment recommendations. Results: The literature search identified 1,244 studies; 124 studies met the inclusion criteria, and 89 studies provided data suitable for statistical analyses. Evidence for the following interventions is presented in this review: cognitive-behavioral therapy for insomnia, brief therapies for insomnia, stimulus control, sleep restriction therapy, relaxation training, sleep hygiene, biofeedback, paradoxical intention, intensive sleep retraining, and mindfulness. This review provides a detailed summary of the evidence along with the quality of evidence, the balance of benefits vs harms, patient values and preferences, and resource use considerations. Citation: Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021;17(2):263–298.

Abstract Study Objectives Cognitive behavioral insomnia therapy (CBT-I) combined with supervised open-label tapering is effective for helping hypnotic-dependent patients discontinue their hypnotics. This study tested whether slowing the tapering pace and blinding the tapering process enhance outcomes. Methods Seventy-eight benzodiazepines (BZD) or benzodiazepine receptor agonists (BZRA) users completed 4 CBT-I sessions, followed by a randomly assigned blinded tapering protocol wherein hypnotic dosage was: held constant, reduced by 10% every two weeks, or reduced by 25% every two weeks. After 20 weeks those who did not have their medications reduced were offered an open-label tapering protocol. Participants completed assessments 3 months after completing their respective tapering protocols. Outcomes included discontinuation rates, hypnotic withdrawal effects, and responder and remission rates determined by Insomnia Severity Index (ISI) scores. Results No differences were observed between the two tapering paces (10% vs. 25%). Blinded tapering had a consistent association with better outcomes that did not reach statistical significance. At 3-month follow-up the number of patients needed to be treated with blinded taper instead of open-label tapering in order for one additional individual to achieve desired endpoints was 7.7 for BZD/BZRA discontinuation, 3.4 for hypnotic withdrawal effects, 4.4 for ISI responder status, and 5.0 for insomnia remission. One-third (32.3%) of the sample was using benzo-related hypnotics at 3-month follow-up. Twice as many individuals (64.6%) were using some type of medication or substance for sleep at this time point. Conclusions Blinding tapering may enhance hypnotic discontinuation rates and insomnia treatment response and remission rates. Trial Registration: Clinicaltrials.gov Identifier: NCT02831894, “The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation;” URL:https://clinicaltrials.gov/ct2/show/NCT02831894?term=hypnotics&cond=Insomnia&cntry=US&state=US%3ACO&city=Denver&draw=2&rank=2

Background Obstructive sleep apnea (OSA) and insomnia are commonly co-occurring conditions that amplify morbidity and complicates the management of affected patients. Unfortunately, previous research provides limited guidance as to what constitutes the best and most practical management approach for this comorbid patient group. Some preliminary studies show that when cognitive behavioral insomnia therapy (CBT-I) is combined with standard OSA therapies for these patients, outcomes are improved. However, the dearth of trained providers capable of delivering CBT-I has long served as a pragmatic barrier to the widespread use of this therapy in clinical practice. The emergence of sophisticated online CBT-I (OCBT-I) programs could improve access, showing promising reductions in insomnia severity. Given its putative scalability and apparent efficacy, some have argued OCBT-I should represent a 1st-stage intervention in a broader stepped care model that allocates more intensive and less assessable therapist-delivered CBT-I (TCBT-I) only to those who show an inadequate response to lower intensity OCBT-I. However, the efficacy of OCBT-I as a 1st-stage therapy within a broader stepped care management strategy for insomnia comorbid with OSA has yet to be tested with comorbid OSA/insomnia patients. Methods/design This dual-site randomized clinical trial will use a Sequential Multiple Assignment Randomized Trial (SMART) design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with OCBT-I improves short-term outcomes of comorbid OSA/insomnia and (2) providing a higher intensity 2nd-stage CBT-I to patients who show sub-optimal short-term outcomes with OCBT-I+PAP improves short and longer-term outcomes. After completing baseline assessment, the comorbid OSA/insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT-I or UC (usual care PAP + sleep hygiene education). Insomnia will be reassessed after 8 weeks. OCBT-I recipients who meet “remission” criteria (defined as an Insomnia Severity Index score < 10) will continue PAP but will not be offered any additional insomnia intervention and will complete study outcome measures again after an additional 8 weeks and at 3 and 6 month follow-ups. OCBT-I recipients classified as “unremitted” after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, extended access to OCBT-I or a switch to TCBT-I. Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points. The primary outcome will be insomnia remission. Secondary outcomes will include subjective and objective sleep data, including sleep time, sleep efficiency, fatigue ratings, PAP adherence, sleepiness ratings, sleep/wake functioning ratings, and objective daytime alertness. Discussion This study will provide new information about optimal interventions for patients with comorbid OSA and insomnia to inform future clinical decision-making processes. Trial registration ClinicalTrials.gov, NCT03109210 , registered on April 12, 2017, prospectively registered.

Sleep is vital to cognition, yet underlying mechanisms remain unclear. Although sleep duration and continuity are two well-established contributors, additional factors-including homeostatic sleep drive processes-may also underlie cognition-related sleep restoration. This study investigates the relative contributions of sleep EEG factors to psychomotor functioning in adults with insomnia and healthy controls (HC) to identify the most significant sleep factors supporting psychomotor functioning. Adults with insomnia ( = 37) and HC ( = 39) completed 3 nights of polysomnography and a complex psychomotor task (switching attention task; SAT). Univariate correlations identified the most significant predictors (traditional PSG, spectral EEG, initial delta peak, and overnight delta decline) of SAT performance, which were then entered into multivariable linear regressions examining whether predictors remained significant after accounting for shortened/fragmented sleep and whether relationships differed across groups. In addition to greater wake after sleep onset (WASO; = 0.33), a slower overnight delta decline ( = 0.50) and a lower initial delta peak ( = -0.38) were the most significant predictors of poorer SAT performance. Both overnight delta decline (F(7, 68) = 12.52, < 0.001) and initial delta peak (F(7, 68) = 7.85, = 0.007) remained significant predictors after controlling for demographics, total sleep time, and WASO. Relationships were analogous across subject groups. Findings suggest that, in addition to sleep duration and continuity, processes related to recovery from and dissipation of homeostatic sleep drive may support psychomotor performance and broadly support daytime functioning in individuals with and without insomnia. Future research may examine overnight delta dynamics as transdiagnostic processes supporting cognition-related sleep restoration across a range of clinical populations.

Abstract Study Objectives: This study examined whether individuals with insomnia and objective short sleep duration <6 h, a subgroup with greater risks of adverse health outcomes, differ in their response to cognitive–behavioral therapy for insomnia (CBT-I) when compared to individuals with insomnia and normal sleep duration ≥6 h. Methods: Secondary analyses of a randomized, clinical trial with 60 adult participants (n = 31 women) from a single academic medical center. Outpatient treatment lasted 8 weeks, with a final follow-up conducted at 6 months. Mixed-effects models controlling for age, sex, CBT-I treatment group assignment, and treatment provider examined sleep parameters gathered via actigraphy, sleep diaries, and an Insomnia Symptom Questionnaire (ISQ) across the treatment and follow-up period. Results: Six months post-CBT-I treatment, individuals with insomnia and normal sleep duration ≥6 h fared significantly better on clinical improvement milestones than did those with insomnia and short sleep duration <6 h. Specifically, individuals with insomnia and normal sleep duration had significantly higher insomnia remission (ISQ < 36.5; χ2[1, N = 60] = 44.72, p < .0001), more normative sleep efficiency (SE) on actigraphy (SE > 80%; χ2[1, N = 60] = 21, p < .0001), normal levels of middle of the night wake after sleep onset (MWASO) <31 minutes (χ2[1, N = 60] = 37.85, p < .0001), and a >50% decline in MWASO (χ2[1, N = 60] = 60, p < .0001) compared to individuals with insomnia and short sleep duration. Additionally, those with insomnia and normal sleep duration had more success decreasing their total wake time (TWT) at the 6-month follow-up compared to those with insomnia and short sleep duration (χ2[2, N = 60] = 44.1, p < .0001). Receiver–operating characteristic curve analysis found that using a 6-h cutoff with actigraphy provided a 95.7% sensitivity and 91.9% specificity for determining insomnia remission, with the area under the curve = 0.986. Conclusions: Findings suggest that individuals with insomnia and objective short sleep duration <6 h are significantly less responsive to CBT-I than those with insomnia and normal sleep duration ≥6 h. Using an actigraphy TST cutoff of 6 hours to classify sleep duration groups was highly accurate and provided good discriminant value for determining insomnia remission.

Study Objectives: Parents of children with chronic illnesses have poorer health related quality of life (HRQoL), shorter sleep duration, and poorer sleep quality than parents of healthy children. However, night-to-night variability of sleep in parents has not previously been considered. This study compared the sleep patterns of parents of ventilator-assisted children (VENT) and healthy, typically developing children (HEALTHY), and examined the relationship between sleep variability and perceived HRQoL. Methods: Seventy-nine mothers and 33 fathers from 42 VENT families (n = 56) and 40 HEALTHY (n = 56) families completed the SF-36 and wore an actigraph for 2 weeks. Reported bedtime and wake time, along with actigraphic total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE) were examined using both average values and night-tonight instability (mean square successive differences). Results: VENT parents showed significantly later bedtimes, shorter TST, longer WASO, and lower SE than HEALTHY parents. VENT parents also exhibited greater instability in their reported wake time, WASO, and SE. Adjusting for family type and gender, greater instability of wake times, WASO and SE were related to poorer SF-36 subscale scores, while averaged sleep values were not. Conclusions: Many parents of ventilator-assisted children experience deficient sleep and show significant instability in their sleep, which was related to HRQoL. Similar to shift workers, variable sleep schedules that may result from caregiving responsibilities or stress may impact parental caregivers' health and well-being. Additional studies are needed to determine how support and other interventions can reduce sleep disruptions in parental caregivers. Citation: Meltzer LJ, Sanchez-Ortuno MM, Edinger JD, Avis KT. Sleep patterns, sleep instability, and health related quality of life in parents of ventilator-assisted children. J Clin Sleep Med 2015;11(3):251–258.

Abstract Study Objective: To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. Design: A blinded, randomized split-plot experimental study. Setting: Two urban academic clinical centers. Participants: 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Interventions: Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Measurements and Results: Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Conclusions: Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH’s sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of CBT-I.

To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions. The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators. The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account. We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.

Study Objectives: This study tested the ecological validity of actigraphy (ACT) for estimating objective sleep parameters in participants' homes. We also examined how well ACT and polysomnography (PSG) measures discriminated (1) individuals with and without insomnia; and (2) nights participants rated worse , the same as , or better than average . Methods: Thirty-one primary insomnia sufferers and 31 normal sleepers completed up to 3 consecutive monitoring nights with wrist ACT and PSG in their homes. They also rated how each night compared to their “average night's” sleep. ACT and PSG measures of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE) were then compared using Bland and Altman correlational procedures and repeated measures ANOVAs. Differences between groups and among nights assigned distinctive ratings were tested via mixed-model ANOVAs. Results: Medium to large between- and within-subject correlations were observed for all measures in the insomnia sufferers sample and for most measures in the normal sleepers sample. Two (ACT vs. PSG) × 3 (nights) repeated measures ANOVAs showed that, in both samples, SOL derived from ACT was consistently lower than SOL derived from PSG across the 3 nights of recording. By contrast, ACT and PSG produced estimates of WASO, TST, and SE that did not differ from each other across nights. Subsequent 2 (insomnia vs. normal sleeper) × 3 ( worse , same , better than average ) mixed-model ANOVAs showed only ACT SOL discriminated those with and without insomnia and nights assigned distinctive ratings. Among the PSG-derived measures, only SE showed such a pattern. Conclusions: ACT provides informative data for insomnia sufferers and normal sleepers in their usual sleep environments. The ACT estimate of SOL seems sensitive to night-to-night differences in subjective sleep ratings. A possible strength of ACT lies in its assessment of nocturnal movement, a parameter different from PSG-based sleep measures. Citation: Sánchez-Ortuño MM; Edinger JD; Means MK; Almirall D. Home is where sleep is: an ecological approach to test the validity of actigraphy for the assessment of insomnia. J Clin Sleep Med 2010;6(1):21–29.