A modified Delphi consensus to reframe and prioritise the management of chronic insomnia in UK primary care

Treat Chronic Insomnia With CBT-I, Says American College of Physicians

PurposeInsomnia is a highly prevalent disorder that is seen across all age groups causing significant morbidity to the patients. Its prevalence has further risen during COVID-19 pandemic. It is widely acknowledged that untreated insomnia can lead to significant health risks and socio-occupational dysfunction.MethodsA narrative review was conducted following focused search of databases.ResultsAvailable guidelines mention two different approaches for the management of insomnia—pharmacological and non-pharmacological. Non-pharmacological therapies like multicomponent cognitive behavior therapy for insomnia (CBT-I) have been advocated for the management of acute as well as chronic insomnia in the literature as it has been found efficacious and useful. Multiple variants of CBT-I, e.g., digitally delivered CBT-I, brief CBT-I have been tested during pandemic owing to closure of clinics. However, there are certain issues to be considered while choosing CBT-I as therapy. For example, like other forms of psychotherapies, is there a need for assessing the candidature of patient before administering CBT-I; is CBT-I free of adverse effects as commonly thought; is CBT-I more efficacious than hypnotics; and at last, how to manage cases that are not candidate for CBT-I.ConclusionThis narrative review addresses the scientific robustness of evidence for issues related to adherence, efficacy and adverse effects of non-pharmacological therapies. Available literature suggests that data related to adherence and efficacy of CBT-I suffer from methodological shortcomings and careful selection of patient is important for the successful therapy. At the same time, attempts have been made to shed light to the areas where CBT-I can be helpful in the management of insomnia.

Insomnia and depression are highly co-morbid conditions that share a complex, bi-directional relationship. By reviewing the literature examining the links between insomnia and depression, it becomes apparent that insomnia symptoms need to be directly targeted alongside depression symptoms when co-morbidities exist for optimal outcomes. The most common treatment in Australia for co-morbid insomnia and depression is currently antidepressant medication. Because a large percentage of individuals given antidepressants fail to remit from their depression and insomnia symptoms, an effective adjunct treatment to antidepressants for co-morbid insomnia and depression is required. Cognitive behavioural therapy for insomnia (CBT-I) is an empirically validated treatment for insomnia, and is efficacious in improving insomnia that is co-morbid with depression. Recent evidence also suggests that CBT-I produces significant improvements in depression severity. The main aim of the thesis was therefore to develop a cost-effective CBT-I intervention that could be easily administered, distributed and implemented on a wide-scale basis, both on its own for insomnia, and primarily as an adjunct therapy for co-morbid insomnia and depression. A therapist manual of CBT-I, based on the latest empirical findings, was specifically developed to increase consistency and ease of treatment administration by therapists wanting to deliver CBT-I treatment. A resource booklet was also developed to give to all individuals undergoing CBT-I treatment, to ensure that they were provided with the latest information about sleep and how to reduce their insomnia severity. A randomised controlled trial was then developed to investigate the efficacy of this CBT-I intervention in individuals with co-morbid insomnia and depression whose symptoms have failed to remit through antidepressant treatment. Forty-one participants (aged 18-64 years) were randomized to receive four sessions of either CBT-I or sleep education (self-help therapy) over an 8-week period (one session every two weeks). Participants had been treated with antidepressants for at least six weeks prior to screening, but were otherwise healthy. The Insomnia Severity Index and the Beck Depression Inventory were assessed at baseline, following each session, and at 3-month follow-up. Secondary outcomes were sleep quality and duration (actigraphy and self-report), anxiety, fatigue, and daytime sleepiness. Results indicated that CBT-I, compared to sleep education, produced significantly reduced depression and insomnia severity, and improved anxiety, fatigue, sleep quality and sleep efficiency. It is the first randomised controlled trial of CBT-I for co-morbid insomnia and depression, with an active control treatment, to show significant reductions in both insomnia and depression severity at post-treatment and follow-up. Large effect sizes were found for both insomnia and depression at post-treatment, and these effect sizes increased further by three month follow-up. At follow-up, ten times more CBT-I participants were in remission from both insomnia and depression than sleep education participants. This demonstrates that CBT-I is an efficacious treatment for co-morbid insomnia and depression, and should be considered an important adjunct therapy in individuals whose symptoms have not remitted through antidepressant treatment. Following the positive results of the randomised controlled trial, the proposed mediators of CBT-I were examined to determine which aspects of the intervention had the largest influence on reductions in insomnia and depression severity at post-treatment and 3-month follow-up. Changes in time-in-bed, bedtime variability, rise-time variability, sleep hygiene practices, dysfunctional beliefs about sleep and stress levels were assessed as potential mediators. Post-treatment results indicated that the significantly reduced depression severity through CBT-I was primarily via reduced stress levels, improved sleep hygiene practices, and other therapeutic effects of CBT-I, whereas reduced insomnia severity was primarily via reduced dysfunctional beliefs about sleep. By follow-up, the significantly reduced depression severity in the CBT-I group was primarily via reduced stress levels and reduced dysfunctional beliefs about sleep, whereas reduced dysfunctional beliefs about sleep and other therapeutic effects of CBT-I explained the significantly reduced insomnia severity. These results indicate that reducing stress levels through CBT-I treatment is required for optimal depression outcomes, whereas reducing dysfunctional beliefs about sleep is essential for optimal insomnia outcomes. Improving sleeping practices behaviourally is important for initial depression improvements, but reducing dysfunctional beliefs about sleep becomes more important for longer-term remission of depression symptoms. Other non-factual therapeutic elements of CBT-I treatment appear to be important, and may lead to a greater willingness to engage in the CBT-I strategies, which can improve depression in the short-term and insomnia in the longer-term. These mediators of CBT-I treatment had not been specifically examined in individuals with co-morbid insomnia and depression before this study. Their identification suggests that relaxation and behavioural sleep interventions should be prioritized initially through CBT-I for co-morbid insomnia and depression, followed by cognitive interventions to target unhelpful beliefs about sleep. By increasing the efficiency of CBT-I, optimal treatment outcomes can be achieved for individuals with co-morbid insomnia and depression, and the risk of future relapse can be minimized.

Comparative effectiveness of CBT interventions for co-morbid chronic pain & insomnia: A pilot study

Introduction Insomnia is the most common sleep disorder affecting up to 30% of the US population with Chronic Insomnia at 10%. Cognitive behavioral therapy for insomnia (CBT-I) has been recommended as the first line treatment and standard of care by the American College of Physicians and American Academy of Sleep Medicine. The goal of CBT-I is to help remedy symptoms and improve sleep quality with the aim of eliminating the reliance on prescription medications. Nonetheless, the use of CBT-I is limited while the use of sleep medications remains high, up to 8% of the US population. The aim of this pilot was to test the use of self-guided CBT-I using mobile app (CBT-I Coach) to reduce chronic insomnia and decrease the need for new sleep aide prescriptions. Methods The one-arm pilot was conducted in a diverse, large university-based family medicine practice. Family medicine providers (n=11) received education on insomnia and recommended primary management with CBT-I. Patient recruitment was completed in 8 weeks and included both referrals and from chart reviews (ICD 10 codes for insomnia). Participants received sleep education including sleep hygiene education and insomnia management with a CBT-I mobile app. Results The 23 participants, aged 25 to 64, reported significant improvement in ISI from moderate to sub-threshold insomnia (baseline M=19.26, SD=3.60 to final M= 14.04, SD=7.0, paired t-test=4.47, df=22, p<.001, Cohen’s d=.93). In response to the intervention, 54.5% assessed their insomnia as “improved”, 36.4% as “stable”, and only 9.1% as "worse.” 71.4% of those taking prescribed medications rated their insomnia as “stable”, 66.7% of those taking Melatonin rated their insomnia as “improved” and 66.7% of those taking nothing at all rated their insomnia as “improved.” Notably, for those taking any sleep aide or medication, there was neither an increase in dosage nor a new prescription during this study. Conclusion Primary care implementation of a self-guided insomnia management program delivered through the app CBT-I Coach can improve sleep quality and insomnia severity. This intervention can especially be beneficial for those taking nonprescription sleep aide (melatonin) or no medication at all. Support (if any)

Guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) as first-line treatment for chronic insomnia, but it is not clear how many primary care physicians (PCPs) in Switzerland prescribe this treatment. We created a survey that asked PCPs how they would treat chronic insomnia and how much they knew about CBT-I. The survey included two case vignettes that described patients with chronic insomnia, one with and one without comorbid depression. PCPs also answered general questions about treating chronic insomnia and about CBT-I and CBT-I providers. Of the 820 Swiss PCPs we invited, 395 (48%) completed the survey (mean age 54years; 70% male); 87% of PCPs prescribed sleep hygiene and 65% phytopharmaceuticals for the patient who had only chronic insomnia; 95% prescribed antidepressants for the patient who had comorbid depression. In each case, 20% of PCPs prescribed benzodiazepines or benzodiazepine receptor agonists, 8% prescribed CBT-I, 68% said they knew little about CBT-I, and 78% did not know a CBT-I provider. In the clinical case vignettes, most PCPs treated chronic insomnia with phytopharmaceuticals and sleep hygiene despite their lack of efficacy, but PCPs rarely prescribed CBT-I, felt they knew little about it, and usually knew no CBT-I providers. PCPs need more information about the benefits of CBT-I and local CBT-I providers and dedicated initiatives to implement CBT-I in order to reduce the number of patients who are prescribed ineffective or potentially harmful medications.

Efficacy of cognitive behavioral therapy for insomnia in geriatric primary care patients.

Objective To compare the effectiveness of protocols for acceptance and commitment therapy for insomnia (ACT-I) and cognitive behavioral therapy for insomnia (CBT-I) in adults. Method Participants were 37 adults (74.3% women; M = 43.7 years, SD = 10.7) with chronic insomnia who were randomized to 6 weekly group sessions consisting of ACT-I (n = 19) or CBT-I (n = 18). The primary outcome measures were based on the Insomnia Severity Index (ISI) total score, a measure of insomnia complaints, and included the proportions of treatment responders (defined as a change in score of 8 points or more) and remitters (defined as a final score below 8). Results Both treatment modalities significantly reduced insomnia severity. Post-treatment, the proportion of treatment responders was higher in the CBT-I than the ACT-I (64.7% vs. 50.0%, respectively) group and six months later, ACT-I made further improvements whereas CBT-I had a reduced treatment response (58.8% vs. 55.6%, respectively). CBT-I was associated with a higher proportion of insomnia remission at post treatment. Conclusions Both CBT-I and ACT-I are effective, with a higher proportion of insomnia remitters in CBT-I post-treatment. The different change trajectories for the two therapy groups provide insights into behavioral change via a cognitive versus contextual approach.

Effectiveness of cognitive behavioral therapy for pharmacotherapy-resistant chronic insomnia: a multi-center randomized controlled trial in Japan

IntroductionInsomnia is the most common sleep disorder, and it adversely impacts daily living and increases the risk of chronic and acute health problems. Of the few individuals who seek treatment...

Introduction Insomnia affects 10 to 20 percent of Americans annually. Unfortunately, evidence-based training on the diagnosis and management of insomnia during U.S. undergraduate medical education is limited. This educational gap may promote use of off-label medications or supplements (e.g., melatonin) and contribute to the “medicalization of sleeplessness”. By contrast, cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommendation of the American Academy of Sleep Medicine and the American College of Physicians, and CBT-I is increasingly available in a digital format that can even be prescribed by primary care providers. Most physicians are not trained in how CBT-I works, however, and thus are ill-equipped to prescribe or refer this service. Therefore, this pilot study evaluated a brief educational intervention to improve medical student knowledge about insomnia. Methods The first author (AST) developed a 20-minute in-person lecture on insomnia which was delivered to 122 undergraduate medical students during their third-year medical curriculum. Topics included epidemiology, Spielman’s 3-P model of pathophysiology, and the treatment recommendations from the AASM with an emphasis on CBT-I. A total of 43 students (36%) provided informed consent and provided pre- and post-presentation ratings (0–100-point scale) of 1) their comfort in discussing insomnia with their patients, 2) the importance of insomnia for human health, 3) their familiarity with the pathophysiology of insomnia, and 4) their familiarity with treatments for insomnia. Participants were additionally asked to categorize a list of treatments as evidence-based or not. Results Following the presentation, students reported increased comfort in discussing insomnia with their patients, knowledge of the pathophysiology of insomnia, and knowledge of evidence-based treatments. In selecting treatments, more students chose CBT-I as an evidence-based treatment, while fewer students identified sleep hygiene, PAP therapy, diphenhydramine, hydroxyzine, melatonin, quetiapine, and trazodone. Conclusion A brief lecture on insomnia improved medical students’ knowledge of the disease process and evidence-based treatments for insomnia. Forthcoming analyses will determine whether students utilized this knowledge during subsequent clerkships. Future work will examine whether alternative formats (e.g., flipped-class, case-based instruction, interactive modules) are more effective for conveying this information. Support (if any)

Cognitive behavioural therapy for insomnia (CBTi): From randomized controlled trials to practice guidelines to implementation in clinical practice.

Background Practice guidelines recommend that chronic insomnia be treated first with cognitive behavioural therapy for insomnia (CBT-I), and that hypnotic medication be considered only when CBT-I is unsuccessful. Although there is evidence of CBT-I’s efficacy in research studies, systematic reviews of its effects in primary care are lacking. Aim To review the effects on sleep outcomes of CBT-I delivered in primary care. Design and setting Systematic review of articles published worldwide. Method Medline, PsycINFO, EMBASE, and CINAHL were searched for articles published from January 1987 until August 2018 that reported sleep results and on the use of CBT-I in general primary care settings. Two researchers independently assessed and then reached agreement on the included studies and the extracted data. Cohen’s d was used to measure effects on sleep diary outcomes and the Insomnia Severity Index. Results In total, 13 studies were included. Medium-to-large positive effects on self-reported sleep were found for CBT-I provided over 4–6 sessions. Improvements were generally well maintained for 3–12 months post-treatment. Studies of interventions in which the format or content veered substantially from conventional CBT-I were less conclusive. In only three studies was CBT-I delivered by a GP; usually, it was provided by nurses, psychologists, nurse practitioners, social workers, or counsellors. Six studies included advice on withdrawal from hypnotics. Conclusion The findings support the effectiveness of multicomponent CBT-I in general primary care. Future studies should use standard sleep measures, examine daytime symptoms, and investigate the impact of hypnotic tapering interventions delivered in conjunction with CBT-I.

Practice guidelines recommend that chronic insomnia be treated first with cognitive behavioural therapy for insomnia (CBT-I), and that hypnotic medication be considered only when CBT-I is unsuccessful. Although there is evidence of CBT-I's efficacy in research studies, systematic reviews of its effects in primary care are lacking. To review the effects on sleep outcomes of CBT-I delivered in primary care. Systematic review of articles published worldwide. Medline, PsycINFO, EMBASE, and CINAHL were searched for articles published from January 1987 until August 2018 that reported sleep results and on the use of CBT-I in general primary care settings. Two researchers independently assessed and then reached agreement on the included studies and the extracted data. Cohen's d was used to measure effects on sleep diary outcomes and the Insomnia Severity Index. In total, 13 studies were included. Medium-to-large positive effects on self-reported sleep were found for CBT-I provided over 4-6 sessions. Improvements were generally well maintained for 3-12 months post-treatment. Studies of interventions in which the format or content veered substantially from conventional CBT-I were less conclusive. In only three studies was CBT-I delivered by a GP; usually, it was provided by nurses, psychologists, nurse practitioners, social workers, or counsellors. Six studies included advice on withdrawal from hypnotics. The findings support the effectiveness of multicomponent CBT-I in general primary care. Future studies should use standard sleep measures, examine daytime symptoms, and investigate the impact of hypnotic tapering interventions delivered in conjunction with CBT-I.

This European guideline for the diagnosis and treatment of insomnia was developed by a task force of the European Sleep Research Society, with the aim of providing clinical recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The target audience for this guideline includes all clinicians involved in the management of insomnia, and the target patient population includes adults with chronic insomnia disorder. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations. The diagnostic procedure for insomnia, and its co-morbidities, should include a clinical interview consisting of a sleep history (sleep habits, sleep environment, work schedules, circadian factors), the use of sleep questionnaires and sleep diaries, questions about somatic and mental health, a physical examination and additional measures if indicated (i.e. blood tests, electrocardiogram, electroencephalogram; strong recommendation, moderate- to high-quality evidence). Polysomnography can be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders), in treatment-resistant insomnia, for professional at-risk populations and when substantial sleep state misperception is suspected (strong recommendation, high-quality evidence). Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence). A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence). Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence). Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).